Patent Application
20250099951
The present invention relates to a device for collecting and testing a liquid sample, and in particular, to a device for collecting and testing an analyte in a liquid sample in the field of rapid diagnosis, such as a urine and saliva collection and testing device.
The following description is merely an introduction of some background knowledge and does not constitute any limitation to the present invention.
At present, the test device for detecting the presence or absence of an analyte in sample is widely used in hospitals or homes, and such test device for rapid diagnosis includes one or more test strips, such as early pregnancy detection and drug abuse detection. Such test device for rapid diagnosis is very convenient, and can obtain a testing result from the test strips after one minute or no at most about ten minutes. Drug detection is widely used by the drug control department, the Public Security Bureau, drug rehabilitation centers, physical examination centers, physical examination offices of national conscription, etc. The drug detection is diverse and frequent. Some detections are required to collect samples and then samples are detected in professional testing agencies or testing laboratories, and some detections need to be completed in the site in time, for example, roadsides, for example, persons who drive after drug use need to be tested on the spot (referred to as “Drug Driving”), to obtain the test results in time.
For example, the detection of saliva samples is gradually accepted and favored by testing agencies or testing personnel due to convenient collection. In some literatures, various sample collection and test devices for clinical and domestic uses have been described. For example, the U.S. Pat. No. 5,376,337 discloses a saliva sampling device in which a piece of filter paper is used for collecting saliva from the mouth of a subject and deliver saliva to an indicator reagent. U.S. Pat. Nos. 5,576,009 and 5,352,410 each disclose a syringe-type liquid sampling device. For another example, a US patent application with the application number of Ser. No. 14/893,461 and publication number of US2016/0121322A1 discloses a test device for a sample; the patent only discloses some basic detection schemes and principles, and appears more difficult in the actual implementation of a specific product. For example, how to compress the pipet tip for absorbing saliva and how to move it if the cover combination is matched with the detection combination, as well as how to mix with liquid effectively, the practical effects are undesirable.
For example, collectors disclosed in US patent applications US 2020/0141934 A1, U.S. Pat. Nos. 7,879,623 B1, 10,564,155 B1, and 7,879,623 B1 are connected with detection chambers, but cannot perform secondary validation; when the secondary validation needs to be performed, it is necessary to collect samples with two collectors, and then one of the collectors is used for testing, and the other thereof is used for secondary validation, so an operation is still cumbersome. In addition, such operation is not easy to implement in some cases where a sample size is small, and is cumbersome especially for saliva samples.
In view of the above technical problems in some conventional products, it is necessary to improve them and provide an alternative approach to solve the drawbacks of the prior art.
In view of the above situations, in order to overcome defects in the conventional technology, an objective of the present invention is to provide a device for detecting an analyte in a liquid sample, and the device can implement primary test of the liquid sample; when such detection needs to be performed and validated, a sample chamber and a detection chamber can be separated. This can realize primary sampling and two tests. In addition, an absorption element that can be compressed is used for storage and secondary sampling. The absorption element being used for storing samples during secondary test can ensure that liquid therein will not be volatilized or evaporated due to dry environment, and increase the safety of storage. For example, the liquid is not easy to leak from a container. However, a conventional container for storing secondary validation samples is an empty container, and an amount of liquid is very small; if the liquid sample is a saliva sample, the liquid sample is easy to evaporate and dry during transportation, thereby causing a sampling difficulty in the secondary validation. In the present invention, a water-absorbent element is used for absorbing and retaining liquid samples, for example, saliva samples, which can effectively preserve saliva. When the saliva is needed and tested, only the sample chamber is allowed to transport the saliva to a secondary validation center for detection, and the absorption element is allowed to be compressed to release the remaining liquid for secondary validation test.
In order to solve the problem, the present invention provides a test device, and the test device includes a sample chamber and a detection chamber, where the sample chamber is in fluid communication with the detection chamber. In some embodiments, the sample chamber is configured to receive a collector for collecting a liquid sample; and the detection chamber includes a testing element used for testing presence or absence of analytes in the liquid sample. In some embodiments, the sample chamber and the detection chamber are detachably combined, so when detection needs to be performed, the sample chamber and the detection chamber are combined and kept in fluid communication. After the detection, the sample chamber and the detection chamber are separated, such that the liquid sample in the sample chamber can be subjected to secondary assay. In some embodiments, a test strip is a lateral flow test strip based on the immune principle, and the secondary assay is a method whose sensitivity is higher than that of an immune lateral flow test, for example, liquid phase, mass spectrometry, gas phase, and other testing methods or measures having relatively high sensitivity. In some embodiments, such detachable combination means that the sample chamber and the liquid chamber are combined together at the beginning and are kept in fluid communication; after primary test, the sample chamber and the liquid chamber are separated.
In some embodiments, the detection chamber is a chamber enclosed by side walls of the detection chamber, and the chamber includes a carrier for carrying the testing element. Generally, the detection chamber is of a flat sheet structure, and the side walls of the detection chamber are provided with one or two notches; for example, a second notch or a second recess is provided in an upper end of the detection chamber; a first recess or a first notch is provided in a lower end of the detection chamber or proximal to a bottom thereof; and the notch is also similar to a tubular shape, and the first notch or the first recess is in fluid communication with the detection chamber. In some embodiments, a first protrusion and a second protrusion are externally provided in side walls of the sample chamber; the protrusions of the sample chamber can be inserted into the notches located in the side walls of the detection chamber, such that the detection chamber and the sample chamber are combined; when the detection chamber and the sample chamber are separated, the first protrusion and the second protrusion are allowed to depart from the first notch and the second notch that are located in the detection chamber to realize separation thereof. In some embodiments, the first protrusion includes a liquid channel, one end of the liquid channel is connected with the inside of the sample chamber, while the other end thereof is connected with the first notch; the first notch also includes a channel, one end of the channel is connected with the inside of the detection chamber, while the other end thereof is in fluid communication with the liquid channel of the first protrusion, such that the sample chamber is in fluid communication with the detection chamber through the liquid chamber. Thus, liquid in the sample chamber can flow into the detection chamber through the liquid channel. If the liquid channel is proximal to a bottom of the detection chamber, the liquid flows to the bottom of the detection chamber and contacts a sample application area of the testing element located at the bottom of the detection chamber, such that the liquid flows onto the testing element under capillary action to complete test or assay. Such test or assay is primary test or first test, or first assay. In some embodiments, the liquid channel is a channel without capillary force. Of course, the liquid channel can also be a channel without capillary force, and preferably the channel without capillary force. Here, the second protrusion and the second notch can be defaulted, and fitting of the second protrusion and the second notch only causes the sample chamber and the detection chamber to be more stably and firmly combined; and it is also feasible to omit the second protrusion and the second notch. In some embodiments, the detection chamber includes a sealing element for sealing an opening thereof, and the sealing element is used to allow the testing element in the detection chamber to be isolated from the outside, which prevents the testing element from test failure caused by moisture. In addition, an exhaust duct is provided on the sealing element, one end of the exhaust duct is in communication with air in the detection chamber, while the other end thereof is in communication with external atmosphere. When the liquid in the sample chamber flows into the detection chamber through the channel of the first protrusion, it generally enters the detection chamber under pressure and is not blocked by air pressure, such that the liquid can smoothly and quickly flow into the detection chamber. Pressure in the sample chamber generally increases when the absorption element of the collector is inserted into the sample chamber and the collector and an inner wall of the sample chamber are hermetically sealed to compress air in the sample chamber during the compression of the absorption element. The pressure compels liquid released from the absorption element to enter the detection chamber through the liquid channel, an exhaust duct on the detection chamber can reduce the volume of air in the detection chamber, such that the liquid can smoothly enter the detection chamber with the pressure in the sample chamber. The exhaust duct herein is usually millimeter in diameter, and can smoothly exhaust air or gas, instead of liquid.
In some embodiments, the sample chamber can further include a third protrusion, and a detachable cover is arranged on the third protrusion and used for sealing the channel of the first protrusion in the sample chamber. Thus, when the sample chamber and the detection chamber are separated, the liquid channel of the first protrusion in the sample chamber is in communication with the outside, and the first protrusion is sealed by the cover, thereby preventing the liquid in the sample chamber from leaking through the liquid channel or allowing the liquid in the sample chamber to evaporate through the liquid channel. In some embodiments, the cover and the first protrusion are meshed together through a thread structure. Thus, when the cover is combined at a partition between the sample chamber and the detection chamber, the cover cannot be found by an operator. Once the cover is separated, the liquid channel of the first protrusion in the sample chamber is not in communication with the detection chamber, but is exposed to the outside; the liquid channel is sealed by the cover, such that the remaining liquid in the sample chamber will not leak or evaporate under external dry environment.
In some embodiments, the sample chamber includes a secondary validation test chamber, and the sample chamber is used for receiving and storing the liquid sample for subsequent secondary validation test. In some embodiments, the secondary validation test chamber includes an absorption element, and the absorption element can absorb liquid and can be compressed to release the liquid. In some embodiments, a first absorption element that is located on the collector and has absorbed the liquid sample is compressed in the sample chamber to release a part of the liquid sample, the released liquid sample is absorbed and stored by a second absorption element in the secondary validation test chamber, while an excess amount of the liquid sample flows into the detection chamber through the liquid channel. Therefore, in some embodiments, the liquid channel is in fluid communication with the secondary validation test chamber and the detection chamber. Alternatively, the liquid released by the first absorption element on the collector flows into the secondary validation test chamber, a part of the liquid flows into the detection chamber through the liquid channel for primary test, and the other part thereof is absorbed and stored by the second absorption element. When the sample chamber and the detection chamber are separated, the second absorption element is allowed to be compressed to release the liquid sample for secondary test or assay. In some embodiments, an amount of the liquid absorbed by the second absorption element is constant, that is, an amount of liquid absorbed to a saturated state is constant, while a volume of liquid absorbed by the first absorption element to a saturated state is greater than that of liquid absorbed by the second absorption element to a saturated state, where the first absorption element is located on the collector and can be compressed. Thus, an amount or a volume of liquid released by compressing the first absorption element is greater than or the volume of liquid absorbed by the second absorption element to a saturated state. This causes the excess liquid to flow into the detection chamber for the primary immunity test.
In some embodiments, after the first absorption element on the collector absorbs the liquid, the liquid released by compressing the first absorption element in the sample chamber is completely absorbed by the second absorption element, and then a first pressure is applied to the second absorption element, such that the second absorption element is compressed to release a part of the liquid; the released liquid flows into the test device through the liquid channel of the first protrusion, in this case, some chemical reagents can be treated in advance on the second absorption element, and the chemical reagents can improve the fluidity of the liquid sample; for example, the chemical reagents can destroy proteins in the liquid sample or eliminate interfering substances therein, thereby facilitating the fluidity of the liquid sample on the testing element, for example, all chemical reagents in EP2823309B1 can be used in the present invention. After primary test and first detection, the sample chamber and the detection chamber are allowed to be separated, and then the cover on the sample chamber seals the liquid channel of the first protrusion; when secondary validation needs to be performed, the cover is removed, such that the second absorption element is subjected to a second pressure again and compressed again, thereby releasing the liquid; the released liquid also flows from the raised channel and is used for secondary test. In fact, the liquid sample absorbed by the second absorption element is compressed to release the liquid by applying the first pressure, and the released liquid is used for primary test. The other part of the liquid is compressed to release the liquid by applying the second pressure, and the released liquid is used for secondary validation test. In this case, the liquid released by the first absorption element on the collector is completely absorbed by the second absorption element; the amount of liquid absorbed by the second absorption element to a saturated state may be greater than or equal to an amount or a volume of liquid absorbed by the first absorption element to a saturated state. In some embodiments, applying pressure to the second absorption element twice is that the position of the collector in the sample chamber is changed to constantly apply pressure in stages, or may be that the collector is allowed to move as a whole to apply the first pressure to the second absorption element, and when secondary test is performed, some accessories in the collector move relative to the collector to apply the second pressure to the second absorption element. For example, after the collector is inserted into the sample chamber, the liquid sample collected by the collector is completely released to be absorbed by the second absorption element in the secondary validation test chamber, and the collector applies the first pressure to the second absorption element, such that the second absorption element is compressed to release the liquid, and the released liquid flows into the detection chamber through the liquid channel to complete primary test. After the sample chamber and the detection chamber are separated, the collector is allowed to move downward continuously to apply the second pressure to the second absorption element, such a part of the liquid is released for second detection validation. A stop block can be applied in the sample chamber, such that the collector has a first position and a second position in the sample chamber. At the first position, the collector releases the liquid and applies the first pressure to the second absorption element. At the second position, the collector applies the second pressure to the second absorption element. Generally, at the first position, the collector is distal to the bottom of the sample chamber; at the second position, the collector is proximal to the bottom of the sample chamber; in this case, the secondary validation test chamber is located near the bottom of the sample chamber and formed by sealing a part of the sample chamber through the collector, and the secondary validation test chamber includes the second absorption element.
In some embodiments, the second absorption element located in the secondary validation test chamber is higher than an inlet of the liquid channel in the first protrusion; thus, when the second absorption element is compressed by the first pressure, the released liquid can flow into the liquid channel and thus into the detection chamber. In some embodiments, the second absorption element on the secondary validation test chamber has a movable cover plate with holes, and the pressure can be applied to movable cover plate to compress the second absorption element. In some embodiments, on the one hand, the cover plate is used for receiving and compressing the first absorption element to release the liquid onto the second absorption element; on the other hand, the cover plate is pressed by the first absorbent element, which compresses the second absorption element. In some embodiments, the cover plate covers the surface of the second absorption element, and when the collector is inserted into the sample chamber and the first absorption element on the collector is compressed, the released liquid flows into the second absorption element through the holes on the cover plate; in this case, the collector seals the sample chamber, such that the secondary validation test chamber and the absorption element therein are hermetically sealed, the absorption element of the collector is compressed to allow the liquid to enter the second absorption element, and the second absorption element is allowed to absorb the liquid to a saturated state. After the second absorption element absorb the liquid to a saturated state, the excess liquid on the first collector enters the second absorption element, flows into the liquid channel of the first protrusion, flows into the bottom of the detection chamber through the liquid channel, and contacts the testing element in the detection chamber, thus completing the primary test of the immune principle.
In some embodiments, the sample chamber further includes a movable chamber for receiving the collector with the first absorption element, and the first absorption element on the collector can be compressed in the movable chamber to release the liquid. In some embodiments, the secondary validation test chamber is located in the sample chamber, and the movable chamber causes the secondary validation test chamber to be in a sealing state. At the same time, the secondary validation test chamber includes an absorption element, and the second absorption element absorbs the liquid sample. In some embodiments, the secondary validation test chamber is located in the sample chamber, and hermetically sealed by the movable chamber; thus, when the movable chamber moves downward, air in the secondary validation test chamber can be compressed. This facilitates the excess liquid in the secondary validation test chamber to flow from the liquid channel of the first protrusion into the detection chamber. When the first absorption element on the collector is inserted into the movable chamber, the bottom of the movable chamber is provided with a through hole, and the absorption element is in contact with the bottom of the movable chamber to be compressed to release the liquid sample into the sealed secondary validation test chamber below the absorption element, and the second absorption element is provided in the sealed secondary validation test chamber and used for absorbing and storing a part of the liquid for secondary test. It can be understood that the collector is inserted into the movable chamber and is also hermetically sealed with the walls thereof, such that the secondary validation test chamber is sealed.
It can be understood that the so-called “sealing” in the secondary validation test chamber here does not mean that the secondary validation test chamber is completely sealed and cannot exchange any gas or liquid with the outside. The sealing here means that the entire secondary validation test chamber is sealed, and only the liquid channel is in communication with the secondary validation test chamber and the detection chamber, and it can also be considered that only the liquid channel is in fluid communication with the outside; generally, the liquid channel is used for transporting the liquid, and when the volume of the sealed secondary validation test chamber shrinks, the pressure increases, and the increased pressure compels the internal liquid to flow out through the liquid channel. Thus, an ultimate goal is to remove the liquid, and at the same time, the pressure of the sealed secondary validation test chamber is kept in balance with the outside, such that the liquid flows more smoothly, and this is a necessary condition for the implementation of the present invention.
In some embodiments, there is a space between the second absorption element and the bottom of the movable chamber, and the space is the same as the liquid channel connecting the sample chamber and the detection chamber. When the movable chamber is at the first position, the liquid released by compressing the first absorption element on the collector flows into the space, and a part of the liquid is absorbed by the second absorption element in the secondary validation test chamber or absorbed by it to a saturated state, and the other part thereof is located in the space. In this case, the movable chamber drives the collector to move downward together. This actually compresses the space of the secondary validation test chamber, compelling the liquid in the space to flow into the detection chamber through the liquid channel for primary assay or test. After the primary assay, the sample chamber and the detection chamber are separated, the cover seals an outlet of the liquid channel on the first protrusion; and when the secondary assay needs to be performed, the movable chamber is allowed to compress the second absorption element at the bottom again to release the part of the liquid. In order to enable the movable chamber to directly compress the second absorption element, a structure for applying pressure is extended at the bottom of the movable chamber and is located in the space. Thus, when the movable chamber moves downward again, the extended structure directly applies pressure to the second absorption element, such that the second absorption element is compressed to release the liquid into the space, and the space continues to be subjected to the pressure of the downward movement of the movable chamber, thereby allowing the liquid to flow into the space through the liquid channel for the secondary test of the sample.
In other some embodiments, the sample chamber and the detection chamber are an integral structure, and cannot be disassembled or separated, and the secondary validation test chamber is not located in the sample chamber, but beside the detection chamber. The secondary validation test chamber, the sample chamber, and the detection chamber are kept in fluid communication. The liquid collected by the collector is released by applying the pressure to the sample chamber, and the released liquid flows into the bottom of the detection chamber through the liquid channel connecting the detection chamber to join in the primary test of the testing element. Any excess liquid sample, if any, flows into the secondary validation test chamber, and the secondary validation test chamber includes the second absorption element, where the second absorption element absorbs the excess liquid sample for storage or preservation. When secondary validation test needs to be performed, the second absorption element can be directly removed for secondary test. In some embodiments, for ease of removal, the second absorption element is fixed onto a carrier, the carrier has a sealing element, and the sealing element is sealed with the secondary validation test chamber, such that the second absorption element is sealed in the secondary validation test chamber. When secondary validation test needs to be performed, the carrier is directly removed from the secondary validation test chamber to compress the second absorption element to release the liquid. Alternatively, after the primary test, the carrier is directly removed from the secondary validation test chamber and loaded into a small bottle; then, the small bottle is delivered or transported to a secondary validation test center. In case of test, the carrier including the second absorption element is removed from the small bottle to compress the second absorption element to release the liquid. The second absorption element including the carrier can be called a second collector. Of course, the second collector does not directly collect liquid samples (for example, the second collector absorbs saliva from the mouth of a test subject), but absorbs a part of the liquid released by compressing the first absorption element. In some embodiments, the first absorption element and the second absorption element may be both compressed and have water absorptivity, and therefore may be made of same materials or different materials; for example, the materials may be filter paper, sponge, polyester fiber and any other materials that can absorb water and be compressed to release liquid.
According to the present invention, absorption elements are used for transferring or storing secondary validation samples; thus, the present invention has the advantages that the absorption elements absorbs the liquid, which is convenient for transportation and transfer; and the loss of the liquid caused by the evaporation thereof can be avoided during transportation. A conventional secondary sampling container is used for storing a liquid sample, which may result in leakage of the liquid sample during transportation; and the liquid sample is likely to evaporate if the secondary sampling container is not sealed properly. Especially for saliva samples, they are sticky and rich in protein; if the saliva samples have a relatively small amount of liquid, such as 10-100 μL, the liquid is likely to leak or evaporate and dry in the secondary sampling container, the saliva samples cannot be sampled for the secondary test. However, if the small amount of liquid is absorbed by the second absorption element and sealed for preservation, the liquid is not easy to evaporate and dry or leak because the absorption elements have the capillary force. Therefore, the first absorption element and the second absorption element may be made of same materials or different materials. It is proved based on our experiments that 50 μL liquid stored by a container without an absorption element and 50 μL liquid absorbed by the absorption element are both placed in dry air (with humidity of 20%); in a case that a temperature is 40° C., the container stored with the liquid will dry in 24 hours due to the evaporation of the liquid, the liquid stored in the absorption element still exists and can be released about 40 μL by compressing the absorption element, and the absorption element still can be compressed to release the liquid sample after kept continuously for 120 hours, which can meet the amount used in the secondary validation. Of course, the volume of liquid absorbed by these second absorption elements for secondary validation and sample storage is quantitative, for example, any volume of samples in 10-1000 μL, which depends on an amount of liquid absorbed by the second absorption element to a saturated state. Of course, the volume of the liquid absorbed by the second absorption element to a saturated state is determined by the volume of the second absorption element (when the material is unchanged). Such volume can be freely selected, and at the same time, the second absorption element is not stored in the sealed secondary validation test chamber, so the second absorption element can be compressed during the secondary validation; alternatively, the second absorption element can be removed from the sealed secondary validation test chamber and then compressed to release the liquid. Of course, the absorption element can also be soaked in an eluent to dissolve the liquid sample or the analyte on the absorption element, and then the secondary validation can be carried out.
The present invention also includes the following specific technical solutions:
A device for detecting an analyte in a liquid sample is provided, and the device includes: a sample chamber for accommodating a collector; and a detection chamber in fluid communication with the sample chamber; where the detection chamber includes a testing element therein, and the testing element is configured to detect the analyte in the liquid sample for the first time; and the sample chamber is detachably combined with the detection chamber.
In some embodiments, the collector includes a first absorption element that is used for absorbing the liquid sample and can be compressed.
In some embodiments, the device further includes a secondary validation test chamber, where the secondary validation test chamber includes an absorption element that can absorb the liquid sample and be compressed.
In some embodiments, the secondary validation test chamber is located in the sample chamber, and when the collector is inserted into the sample chamber, the secondary validation test chamber is hermetically sealed. In some embodiments, the first absorption element on the collector is configured to absorb the liquid sample; and when the sample chamber includes the collector, the first absorption element on the collector can be compressed to release the liquid sample, where a part of the released liquid sample can flow into the secondary validation test chamber. In some embodiments, the part of the released liquid can be absorbed and preserved by the second absorption element located in the secondary validation test chamber. In some embodiments, the liquid released by the first absorption element is completely absorbed by the second absorption element. In some embodiments, the second absorption element is allowed to release the liquid sample by applying a first pressure thereon, and the released liquid sample is used in the primary test of the testing element in the detection chamber; and the second absorption element is allowed to release a part of the liquid sample by applying a second pressure thereto, and the released liquid sample is used in the secondary validation test.
In some embodiments, the secondary validation test chamber is in fluid communication with the detection chamber. In some embodiments, a volume of liquid absorbed by the second absorption element in the secondary validation test chamber to a saturated state is constant. In some embodiments, a volume of liquid absorbed by the first absorption element is greater than a volume of liquid absorbed by the second absorption element. In some embodiments, the secondary validation test chamber is located in the sample chamber or in fluid communication with the sample chamber.
In some embodiments, the secondary validation test chamber is in fluid communication with the detection chamber through one liquid channel; alternatively, the secondary validation test chamber is in fluid communication with the sample chamber through the detection chamber and the liquid channel. Thus, the liquid flowing out of the secondary validation test chamber flows into the detection chamber through the liquid channel for primary test or secondary validation test. In some embodiments, the secondary validation test chamber is in fluid communication with the sample chamber through the detection chamber, and the liquid flowing out of the sample chamber can flow into the detection chamber for primary test, while the excess liquid flows into the secondary validation test chamber. In some embodiments, the secondary validation test chamber includes a second collector, where the second collector includes the second absorption element, and when secondary validation test needs to be performed, the second collector including the second absorption element is removed from the secondary validation test chamber, and the second absorption element is compressed to release the liquid for secondary validation.
In some embodiments, the sample chamber includes a first protrusion that includes the liquid channel, and the first protrusion is detachably connected with a first recessed interface of the detection chamber, such that the sample chamber can be in detachable communication with the detection chamber through the liquid channel. In some embodiments, the sample chamber further includes a cover, and the cover is configured to seal the liquid channel when the sample chamber and the detection chamber are separated.
In some embodiments, the sample chamber includes a second protrusion, and the second protrusion is detachably connected with a second recessed interface of the detection chamber. In some embodiments, the sample chamber further includes a third protrusion, and the cover is located on the third protrusion.
In some embodiments, the sample chamber further includes a movable chamber, the movable chamber is configured to receive the collector and allow the first absorption element to be compressed to release the liquid sample, and the movable chamber has a first position and a second position in the sample chamber. In some embodiments, the collector has a bottom; the bottom and the bottom and side walls of the sample chamber are enclosed into the secondary validation test chamber, and the secondary validation test chamber includes the second absorption element for absorbing the liquid sample. In some embodiments, when the first absorption element on the collector or the first collector is compressed to release the liquid, the released liquid flows to the secondary validation test chamber, the second absorption element is allowed to absorb the liquid, and the excess liquid flows to the detection chamber through the liquid channel to contact the testing element for testing and assaying, and the movable chamber is located at the first position. In some embodiments, the collector is inserted into the movable chamber, such that pressure in the secondary validation test chamber is increased, and the increased pressure facilitates the remaining liquid to flow into the detection chamber through the liquid channel. In some embodiments, the secondary validation test chamber is in fluid communication with the detection chamber through the liquid channel. In some embodiments, after the collector and the detection chamber are separated, and when the secondary validation test needs to be performed, the movable chamber is allowed to move the second position, and the second absorption element is compressed by the movable chamber, whereby releasing the liquid through the liquid channel; and the released liquid is used for secondary validation test. In some embodiments, the detection chamber includes a carrier for carrying the testing element, the testing element is located on the carrier, and the detection chamber is in communication with external atmosphere. In some embodiments, the detection chamber includes a sealing body that seals an opening of the detection chamber, a channel is provided on the sealing body, and the channel is in communication with the detection chamber and the external atmosphere. In some embodiments, the device further includes a base, where the detection chamber and the sample chamber are located on the base and combined with the base in a detachable manner. In some embodiments, the analyte is a drug micromolecule. In some embodiments, the liquid sample is saliva, urine or blood.
Further, the present invention provides a method for testing an analyte in a liquid sample, and the method includes: performing primary test on the liquid sample, and then performing secondary validation test on the same liquid sample, where secondary validation samples are stored in the absorption element.
In some embodiments, a test device is provided, and the device includes a sample chamber for inserting a collector, and the collector includes a first absorption element that is used for absorbing a liquid sample and is inserted into the sample chamber, such that the first absorption element is compressed to release the liquid sample into the sample chamber. In some embodiments, when the collector is inserted into the sample chamber, a sealing space is formed at the bottom of the sample chamber, and the sealing space includes a second absorption element, and a part of the liquid released by the first absorption element is absorbed by the second absorption element in the sealing space, and the excess liquid is kept in the sealing space. In some embodiments, there is a liquid channel between the sealing space and the detection chamber. With the movement of the collector, pressure is applied to the sealing space, such that the liquid kept in the sealing space is compelled to flow into the detection chamber through the liquid channel for the initial detection. After the initial detection, the sample chamber and the detection chamber are allowed to be separated.
The primary test and the secondary validation test of the analyte in the liquid chamber can be implemented through the above structure; particularly, the secondary test sample being kept in the absorption element can ensure the existence of the liquid sample to the greatest extent, rather than the reduction of the liquid sample, and the secondary validation test chamber is located in the sample chamber and can be detachably combined with the detection chamber.
The following further describes the structures involved in the present invention or the technical terms used therein. Unless otherwise specified, they shall be understood and explained according to the general terms commonly used in the prior art.
Detection means assaying or testing presence or absence of a substance or material, including but not limited to, chemical substance, organic compound, inorganic compound, metabolite, drug, drug metabolite, organic tissue, metabolite of organic tissue, nucleic acid, protein or polymer. In addition, detection means that the amount of a substance or material is tested. Further, assay also means immunoassay, chemical assay, enzyme assay, and the like.
The samples detected by the test device of the present invention include biological liquid (for example, case liquid or clinical sample). Liquid samples or fluid samples may be derived from solid or semi-solid samples, including feces, biological tissues and food samples. The solid or semi-solid samples may be converted to liquid samples by any appropriate methods, such as mixing, mashing, macerating, incubating, dissolving, or digesting the solid samples by enzymolysis in suitable solutions, such as water, phosphate solutions, or other buffer solutions. “Biological samples” include animal, plant, and food derived samples, including, for example, human or animal derived urine, saliva, blood and components thereof, spinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, cultures of tissues and organs, cell cultures, and media. Preferably, the biological sample is urine, and preferably, the biological sample is saliva. Food samples include food processed materials, final products, meat, cheese, wine, milk, and drinking water. Plant samples include samples derived from any plants, plant tissues, plant cell cultures, and media. “Environmental samples” include samples derived from the environment (e.g., liquid samples from lakes or other bodies of water, sewage samples, earthen samples, groundwater, seawater, and waste liquid samples). The environmental sample may further include sewage or other waste water.
An appropriate test device according to the present invention can be used to detect any analyte. Preferably, the test device of the present invention is used to detect small drug molecules in saliva and urine. Of course, the samples detected by the test device of the present invention may be any samples of the above forms, regardless of being solid or liquid at the beginning, provided that these liquids or liquid samples can be absorbed by the sample application area of the testing element. Generally, the sample application area is made of a water absorbent material, and liquid samples or fluid samples can be absorbed by the capillary or other characteristics of the material of an absorption element, so that the liquid sample can flow in the sample application area. The material of the sample application area may be any material capable of absorbing liquid, such as sponge, filter paper, polyester fiber, gel, non-woven fabric, cotton, polyester film, and yarn. Of course, the sample application area may be made of a water absorbent material or a non-water absorbent material. However, the absorption element is provided with holes, screw threads, and caves on which the samples can be collected. Generally, the samples are solid or semi-solid samples, and filled between screw threads and in the holes or caves for collection. Of course, optionally, the sample application area may be composed of some non-absorbent fibers and hairs, and these materials are used to scrape a solid, semi-solid or liquid sample, so that these samples can be retained on the sample application area. If detection needs to be performed, a buffer solution is applied to the sample application area to dissolve the sample, so that the dissolved sample flows on the testing element or the detection element.
In some embodiments, the liquid sample is located in the detection chamber, instead of being manually applied to the sample application area of the testing element of the present invention, where the sample application area is proximal to the bottom of the detection chamber; when there is the liquid sample at the bottom of the detection chamber, an end portion of the sample application area contacts the liquid sample, the liquid sample sequentially flows into the label area, the testing area, and the sample absorption area depending on the capillary force, thereby completing whole detection or primary test or first test.
Downstream or upstream is divided according to a flow direction of a liquid, generally, a liquid or fluid flows to a downstream area from an upstream area. The downstream area receives the liquid from the upstream area, and a liquid also may flow to a downstream area along an upstream area. Here, downstream or upstream is generally divided according to a flow direction of a liquid, for example, on some materials where capillary force is utilized to facilitate the flow of a liquid, a liquid may overcome gravity to flow towards an opposite direction to the gravity; and in this case, downstream or upstream is divided according to a flow direction of the liquid. For example, in the test device of the present invention, when there is the liquid sample at the bottom of the detection chamber, for example, the liquid sample from the sample chamber, such as a urine sample or a saliva sample of a test subject, can flow from the sample application area to the label area, and then to the testing area, for example, a test result area and a test result control area. The testing area may be a polyester fiber film, and the diversion element may be a glass fiber, a polyester chip, and a polyester film.
Gas flow or liquid flow means that liquid or gas can flow from one place to another place. In a flow process, the liquid or gas may pass through some physical structures to play a guiding role. The “passing through some physical structures” here means that liquid passes through the surface of these physical structures or their internal space and flows to another place passively or actively, where passivity is usually caused by external forces, such as flow under the capillary action and the action of air pressure. The flow here may also be a flow due to self-action (gravity or pressure) of the liquid or gas, and also may be a passive flow. The fluid under the action of air pressure may be a forward flow, or also a reverse flow; or a fluid is urged to flow to another position from a position under the action of air pressure. Here, the flow does not mean that a liquid or a gas is necessarily present, but indicates a relationship or state between two objects under some circumstances. In case of presence of liquid, it can flow from one object to another. Here it means the state in which two objects are connected. In contrast, if there is no gas flow or liquid flow state between two objects, and liquid exists in or above one object but is unable to flow into or on another object, it is a non-flow, non-liquid or non-gas flow state.
The “testing element” used herein refers to an element that can be used to detect whether a fluid sample or a fluid specimen (a liquid sample or a liquid specimen) contains an interested analyte. Such testing can be based on any technical principles, such as immunology, chemistry, electricity, optics, molecular science, nucleic acids, and physics. The testing element can be a lateral flow detection reagent strip that can detect a variety of analytes. Of course, other suitable testing elements can also be used in the present invention.
Various testing elements can be combined for use in the present invention. One form of the testing elements is a test strip. The test strips used for analyzing the analyte (such as drugs or metabolites that show physical conditions) in samples can be of various forms such as immunoassay or chemical analysis. The analysis mode of non-competition law or competition law can be applied for test strips. A test strip generally contains a water absorbent material that has a sample application area, a reagent area, and a testing area. Fluid or liquid samples are added to the sample application area and flow to the reagent area under the capillary action. If analyte exists in the reagent area, samples will bind to the reagent. Then, samples continue to flow to the testing area. Other reagents such as molecules that specifically bind to analyte are immobilized on the testing area. These reagents react with the analyte (if any) in the sample and bind to the analyte in this area, or bind to a reagent in the reagent area. Label used to display the detection signal exists in the reagent area or the detached label area.
Typical non-competition law analysis mode: if a sample contains analyte, a signal will be generated; and if not, no signal will be generated. Competition law: if no analyte exists in the sample, a signal will be generated; and if analyte exists, no signal will be generated.
The testing element can be a test strip, which can be water absorbent material or non-water absorbent material. The test strip can contain several materials used for delivery of liquid samples. One material of the test strip can cover the other material thereof. For example, the filter paper covers the nitrocellulose membrane. One or more materials may be used in one area of the test strip, and one or more other different materials may be used in the other area thereof. The test strip can stick to a certain support or on a hard surface for improving the strength of holding the test strip.
Analyte is detected through a signal generating system. For example, one or more enzymes that specifically react with this analyte is or are used, and the above method of fixing a specific binding substance on the test strip is used to fix the combination of one or more signal generating systems in the analyte testing area of the test strip. The substance that generates a signal can be in the sample application area, the reagent area or the testing area, or on the entire test strip, and one or more materials of the test strip can be filled with this substance. The solution containing a signifier is added onto the surface of the test strip, or one or more materials of the test strip is or are immersed in a signifier-containing solution. The test strip containing the signifier solution is made dry.
Various areas of the test paper can be arranged as follows: sample application area 405, reagent area 407, and testing area 408, where the testing area includes a test result area 411 and a test result control area 410. The test result control area is located behind the testing area. All areas can be arranged on a test strip that is only made of one material. Alternatively, different areas may be made of different materials. Each area can be in direct contact with the liquid sample, or different areas are arranged according to the flow direction of liquid sample; and a tail end of each area is connected and in overlapped with the front end of the other area. Materials used can be those with good water absorption such as filter papers, glass fibers or nitrocellulose membranes. The test strip can also be in other forms.
The nitrocellulose membrane test strip is commonly used, that is, the testing area includes a nitrocellulose membrane (NC) on which a specific binding molecule is immobilized to display the test result; and other test strips such as cellulose acetate membrane or nylon membrane test strips can also be used. For example, test strips and similar devices with test strips disclosed in the following patents: U.S. Pat. Nos. 4,857,453; 5,073,484; 5,119,831; 5,185,127; 5,275,785; 5,416,000; 5,504,013; 5,602,040; 5,622,871; 5,654,162; 5,656,503; 5,686,315; 5,766,961; 5,770,460; 5,916,815; 5,976,895; 6,248,598; 6,140,136; 6,187,269; 6,187,598; 6,228,660; 6,235,241; 6,306,642; 6,352,862; 6,372,515; 6,379,620, and 6,403,383. The test strips and similar device with test strips disclosed in the above patents may be applied to the testing element or test device of the present invention for the detection of an analyte, for example, the detection of an analyte in a sample.
Test strips used in the present invention may be commonly referred as lateral flow test strips. The specific structure and detection principle of the test strips are well known to a person skilled in the art in the prior art. A common test strip (
In addition to the foregoing test strip or lateral flow test strip which is used to contact with the liquid sample to test whether the liquid samples contain analytes. The testing element of the present invention may be used as a test device by itself to detect an analyte in a sample. Therefore, the test device here is equal to a testing element. For example, after being mixed with a treatment solution, the fluid sample is detected with a testing element directly, specifically described as follows: when a receiving device is described to treat a fluid sample, the testing element may be used for detection alone. In the present invention, the testing element is arranged on a carrier 501, and the carrier is provided with a plurality of grooves 504, and each of the grooves is provided with a testing element that can be used for testing an analyte, as shown in
Examples that can use an analyte related to the present invention include some small-molecule substances, including drugs (such as drug of abuse). “Drug of Abuse” (DOA) refers to using a drug (playing a role of paralyzing the nerves usually) not directed to a medical purpose. Abuse of these drugs will lead to physical and mental damage, dependency, addiction and/or death. Examples of drug abuse include cocaine;
amphetamine (AMP) (e.g., Black Beauty, white amphetamine tablets, dexamphetamine, dexamphetamine tablets, and Beans); methamphetamine (MET) (crank, meth, crystal and speed); barbiturate (BAR) (such as Valium, Roche Pharmaceuticals, Nutley, and New Jersey); sedatives (i.e., a sleep aid medicine); lysergic acid diethylamine (LSD); inhibitors (downers, goofballs, barbs, blue devils, yellow jackets, and methaqualone); tricyclic antidepressants (TCAs, i.e. imipramine, amitriptyline, and doxepin); dimethylenedioxymethylaniline (MDMA); phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); opiates (i.e., morphine (MOP) or opium, cocaine (COC), heroin, and hydroxydihydrocodeinone); and anxiolytic drugs and sedative-hypnotic drugs. The anxiolytic drugs are mainly used for relieving anxiety, tension, and fear, and stabilizing emotion, and have hypnotic and sedative effects. The anxiolytic drugs include benzodiazepines (BZO), atypical benzodiazepines (BZ), fused dinitrogen NB23C, benzodiazepines, ligands of BZ receptors, open-ring BZ, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazolinones, thiazine and thiazole derivatives, other heterocycles, imidazole-type sedative/analgesic drugs (e.g., oxycodone (OXY) and methadone (MTD)), propylene glycol derivatives-carbamates, aliphatic compounds, anthracene derivatives, and the like. The test device of the present invention may also be used for detecting drugs belonging to a medical use but easy to be taken excessively, such as tricyclic antidepressants (imipramine or analogues) and acetaminophen. These drugs are metabolized into micromolecular substances after absorbed by human body. These micromolecular substances exist in blood, urine, saliva, sweat and other body fluids or in some body fluids.
For example, the analyte detected by the pre invention includes but is not limited to creatinine, bilirubin, nitrite, (nonspecific) proteins, hormones (for example, human chorionic gonadotropin, progesterone, follicle-stimulating hormone, etc.), blood, leucocytes, sugar, heavy metals or toxins, bacterial substances (such as proteins or carbohydrates against specific bacteria, for example, Escherichia coli 0157: H7, Staphylococcus, Salmonella, Fusiformis, Camyplobacter genus, L. monocytogenes, Vibrio, or Bacillus cereus) and substances related with physiological features in a urine sample, such as pH and specific gravity. Chemical analysis of any other clinical urine may be performed by lateral flow test in combination with the device of the present invention. The sample of the present invention may be urine, and the analyte may be HCG, LH, and other substances, which are used for testing ovulation or early pregnancy.
Detachable combination means that connection relationship between two components is in several different states or positional relationship. For example, with two components being physical components, they can be separated at the beginning and then connected or combined in an appropriate first case, and separated in an appropriate second case. Physically, such separation is spatial separation without contact. Alternatively, the components are combined at the beginning, and can be physically separated from each other when appropriate. Alternatively, two objects are separated at the beginning, combined to achieve a specified function if necessary, then separated, or later combined again for a purpose. In short, combination or separation or two components or two objects can be easily made and repeated many times. Of course, the combination or separation can also be single-use. In addition, such combination can be a detachable combination between two components, or a two-by-two detachable combination between three or more components. For example, a first component, a second component, and a third component are provided, where a detachable combination is made between the first component and the second component or between the second component and the third component; and a detachable combination or separation is made between the first component and the third component. In addition, for the combination, two objects themselves can be detached or can be indirectly combined by other objects.
Sample Preservation after Secondary Validation Test
Second validation here means that after primary test on a sample is performed, it is hoped that secondary test on the sample is performed for validation. The samples for the primary test are the same as those for the secondary validation test. Here, the same samples refer to a same batch of samples, for example, a part of obtained samples are used for the primary test and the other part thereof are used for the secondary validation test. In some embodiments, the accuracy or sensitivity of primary test is lower than that of the secondary validation test. For example, the primary test is performed using an immune-based method for a lateral flow testing element according to the present invention, and a label is a colored particle. If the secondary validation test needs to be performed, a method with better accuracy than immunoassay is used; for example, chromatography, fluorescence immunoassay, radioimmunoassay, gas phase or liquid phase, or gas/liquid phase-mass spectrometry is used for detection. It can be understood that the primary test and the secondary test share methods, for example, the primary test is an immune test, and the secondary test can also be the same as the immune test of the primary test.
A specific embodiment of the present invention is as shown in
The structure of the sample chamber and the structure of the collector are as shown in
After the test, the sample chamber and the detection chamber are allowed to be separated, such that the cover 203 located on the protrusion 602 is meshed with the outside of the protrusion 603, thereby sealing the liquid channel 607; then, the entire sample chamber 60 is allowed to be separated from the base 40, as shown in
The other way is to remove the cover 605 instead of the cover 203. The absorption element has a step 680 in the sealed secondary validation test chamber 608 in the sample chamber, where the step has a big end 701 and a small end 702. The secondary validation test chamber 608 is fully filled with the second absorption element, and the big end 701 cannot be compressed again when compressed to the surface of the step, so the volume of the entire absorption element is reduced, and the second absorption element 70 absorbs the liquid to a saturated state. When the big end 701 is compressed, the liquid released by it normally flows out of the opening 611 of the sample chamber through the small end 702 and may be used for secondary validation test. In the above ways, generally, the volume of liquid absorbed by the second absorption element to a saturated state is constant, that is, the second absorption element can be up to a saturated state only by absorbing a specified volume of liquid instead of more liquid. However, the volume of the liquid absorbed by the first absorption element or the volume of the liquid released by compressing the first absorption element is greater than the volume of the liquid absorbed by the second absorption element to a saturated state, such that the excess liquid can flow into the detection chamber for the primary test. In some embodiments, a space under the baffle is not completely occupied by the second absorption element, but there is a space 785 (with reference to
In some embodiments, the sample chamber 600 can further be provided with a protrusion 6002; the protrusion is not connected with the detection chamber, but is provided with a sealing cover 6008; the sealing cover seals the liquid channel 780 in the sample chamber when the sample chamber 600 and the detection chamber are separated. In some embodiments, the movable chamber 721 is located in the sample chamber 600, and the bottom 782 of the movable chamber is proximal to the bottom of the sample chamber; a space is arranged between the bottom of the movable chamber and the bottom of the sample chamber, and the space is the secondary validation test chamber and used for receiving the liquid sample from the collector. A part of the liquid sample is absorbed by the second absorption element 716 located in the space, while the other part of the liquid sample flows into the detection chamber through the liquid channel for the primary assay.
In some embodiments, the movable chamber 721 includes an opening 426 for receiving the collector 10. In addition, a first sealing element 722 and a second sealing element 723 are arranged on the outer wall of the chamber, and such sealing elements fit with the inner wall 6010 of the sample chamber to form hermetic seal. The second sealing element 723 is arranged close to the bottom of the movable chamber, such that the bottom of the movable chamber and the bottom of the sample chamber form a hermetic seal structure. In some embodiments, the bottom of the movable chamber has a hole 784; when the collector is inserted into the hole, the first absorption element 105 contacts the bottom of the movable chamber and interacts with the bottom of the movable chamber, the first absorption element is compressed to release the liquid, and the released liquid flows into the secondary validation test chamber below the first absorption element through the hole 784. In some embodiments, the movable chamber has a first position and a second position in the sample chamber, the first position and the second position are controlled by the limit structure. When the limit structure is provided, the movable chamber is located at the first position; and if the limit structure is removed, the movable chamber can move from the first position to the second position. In some embodiments, the limit structure is a snap ring 700 with an annular structure, and the annular structure includes a notch 7003; the notch is laterally clamped outside the movable chamber, and a first fixed position of the movable chamber is limited by the opening of the sample chamber. In order to allow the position of the movable chamber to be fixed, an annular structure 724 is arranged near the outer wall of the movable chamber proximal to the opening, thus forming a snap ring area 725; and the snap ring is clamped in the snap ring area, such that the movable area can be better fixed at the first position. In order to allow the position of the snap ring to fit with the inlet of the sample chamber, an interface 6006 and an edge protruding area 6007 at the inlet of the sample chamber. The area and shape of the edge protruding area are just the radian and height of the notch 7003 of the snap ring, and the interface 6006 is an area where the hand-held area 7005 of the snap ring is allowed to be clamped. Thus, the snap ring is fixedly clamped on the outer wall of the movable chamber, and fixed to the sample chamber, and does not rotate axially. As shown in
When the primary test of the liquid sample is completed, the insertion elements 6001, 6003 of the sample chamber are detached from the jacks 207, 208 of the detection chamber, such that the sample chamber and the detection chamber are separated, and the cover 6008 is disassembled from a protruding structure 6002 and sealed on the insertion element that includes the liquid channel 780, thus sealing the entire secondary validation test chamber. In fact, the collector is used to hermetically seal the inside of the movable chamber and the movable chamber is used to hermetically seal the inside of the sample chamber; in the formed hermetic seal space, only the liquid channel is in communication with the detection chamber, while the detection chamber is in communication with the external atmosphere through a pipe 707. Therefore, as the collector moves, the volume of the formed hermetic seal space decreases and the pressure thereof increases, and the increased pressure facilitates the excess liquid (which refers to the remaining liquid sample after the released liquid is absorbed by the second absorption element 716 to a saturated state) to flow into the bottom of the detection chamber only through the liquid channel 780. It can be understood that inserting the collector into the movable chamber, sealing the inside of the movable chamber, and compressing the first absorption element to release the liquid do not need to take a long time, and are substantially completed in a few seconds or dozens of seconds. In some embodiments, a distance is allowed to exist between the surface of the second absorption element and the bottom of the movable chamber, and is not occupied by the second absorption element, as shown in
When the primary test is completed, the sample chamber 600 and the detection chamber can be separated, and the sample chamber includes the movable chamber 721, the first collector 10, and the second absorption element located in the sample chamber 600; in this case, the cover 6008 is used to seal the insertion element 6003 including the channel, and the entire secondary validation test chamber is in a sealed state and can be transported to the laboratory for the secondary validation test. When the secondary validation test needs to be performed, it can be implemented by the following ways. In a first method, the cover 6008 is removed to allow the liquid channel 780 to be in communication with the external atmosphere, and the snap ring 700 is removed to allow the movable chamber to continue to move in the sample chamber to apply the pressure to the second absorption element 716, and the second absorption element is compressed to release the liquid by applying the pressure thereon; and when the movable chamber moves downward, the pressure of the compressed air increases, and such pressure facilitates the liquid released from the second absorption element to flow out of the liquid channel 780 (for example, a test tube) for the secondary validation test. In a second way, the cover 6008 is not removed, but the cover 6009 at the bottom of the sample chamber is removed; then, the second absorption element is compressed to release the liquid, and the released liquid flows out of the bottom of the sample chamber for the secondary validation test. It can be understood that one hole 6004 is provided at the bottom of the sample chamber 600 and is sealed by the cover 6009, and the second absorption element is T-shaped and fixed to a T-shaped step; thus, when the movable chamber 721 moves downwards, the bottom thereof directly contacts the second absorption element and compresses it, and the excess liquid flows out of an opening 786 through the lower part 788 of the second absorption element. In some embodiments, in order to allow the first way to be more easily implemented, a protruding structure 789 is provided at the hole 784 in the bottom of the movable chamber; and the protruding structure extends from the bottom to the surface against the second absorbent element. With the downward movement of the movable chamber 721, the top of the extension structure contacts the second absorbent element, the extension structure compresses the second absorption element to release the liquid, the released liquid flows into the space between the surface of the second absorption element and the bottom of the movable chamber, and the liquid channel 780 communicating the outside is provided in the space; thus, the liquid flowing to the space flows to the outside through the liquid channel 780 for the secondary validation test. Of course, the extension structure can also be some protrusions extending from the bottom of the movable chamber toward the surface of the second absorption element, and the protrusions can also apply pressure to the second absorption element, thereby compressing the second absorption element to release the liquid sample for secondary validation.
Referring to examples as shown in
Correspondingly, a same structure is used for the sample chamber regardless of presence or absence of absorption elements, except that there is no second absorption element and 0.8 ml of the saliva sample is kept in the space 201 without the second absorption element. In other words, a same volume of the saliva sample is absorbed and preserved by the second absorption element of the present invention, or not absorbed and preserved by the second absorption element but preserved in the chamber, and the second absorption element is made of polyester foam.
The liquid sample storage capacity of the sample chamber in different states is investigated. The specific conditions are given below: the above sample chambers each store five liquid samples, the average value thereof is calculated, and the sample chambers are respectively placed in different sealing containers, and each sealing container is stored with five sample chambers. The sealing containers are connected with a negative pressure compression device, air therein is pumped out to keep them be in a constant negative pressure state for different times, and the remaining saliva samples in different conditions are measured. For the sample chamber excluding the second absorption element, the remaining saliva sample is directly measured; for the sample chamber including the absorption element, the absorption element is compressed and the volume of the released liquid is observed. Specific results are as shown in Table 1:
It can be seen from Table 1 that under such negative pressure, the sample chamber including the absorption element can continuously maintain the liquid sample storage capacity, but still has slight decrease mainly with negative pressure and evaporation, and the liquid sample storage capacity of the sample chamber excluding the absorption element rapidly decreases. The reason for evaporation is that it is impossible to accurately seal the sealing containers, but evaporation can occur under negative pressure, resulting in reduction in the liquid volume. The negative pressure is to mainly simulate transportation environment under air transportation.
It can be seen from results in Table 2 that under conditions of constant negative pressure, relatively high temperature and relatively dry external environment, the liquid sample storage capacity of the sample chamber including the absorption element is relatively excellent; generally, the secondary validation test chambers are transported to the laboratory by air or freight from a place where the primary test is performed. During the air transportation, it is easy to reduce volatilization of the liquid in a negative pressure and dry environment, and even sometimes secondary validation cannot be performed because the liquid samples evaporate and dry; in the present invention, the absorption element is used to store the liquid sample, which can effectively avoid the evaporation of liquid; therefore, the absorption element can be used for secondary validation.
All the patents and publications mentioned in the description of the present invention indicate that these are public technologies in the art and can be used by the present invention. All the patents and publications cited herein are listed in the references, just as each publication is specifically referenced separately. The present invention described herein can be realized in the absence of any one element or multiple elements, one restriction or multiple restrictions, where such restriction is not specifically described here. For example, the terms “comprising”, “essentially consisting of” and “consisting of” in each embodiment herein may be replaced by the rest 2 terms. The so-called “a/an” herein merely means “one”, but does not exclude including 2 or more instead of including only one. The terms and expressions which have been employed herein are descriptive rather than restrictive, and there is no intention to suggest that these terms and expressions in this description exclude any equivalents, but it is to be understood that any appropriate changes or modifications can be made within the scope of the present invention and appended claims. It can be understood that the embodiments described in the present invention are some preferred embodiments and features. A person skilled in the art can make some modifications and changes according to the essence of the description of the present invention. These modifications and changes are also considered to fall within the scope of the present invention and the scope limited by independent claims and dependent claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 202311258055.8 | Sep 2023 | CN | national |
