Patent Application
20090155124
1. Field of the Invention
The present invention generally relates to a diagnostic device. More particularly, this invention relates to a device for collecting and analyzing a biological fluid.
2. Related Art
Analytical devices for collecting samples and determining the presence or absence and/or quantifying the amount of various analytes in the samples are known in the market. Assays are usually available for abused drugs, pregnancy and fertility testing, and infectious diseases. Most of these existing analytical devices are typically designed and used to analyze urine samples for testing DOA (Drugs Of Abuse) chemicals. Urine has the traditional problem that the sample is usually collected in private, raising security and handling issues, such as sample tampering.
Therefore, it is preferable in some situations to conduct analysis on a saliva sample rather than on a urine sample. When applicable, saliva collection and analysis has several advantages over urine collection analysis. A saliva specimen can be taken at any convenient time, and can be obtained singly or sequentially. Moreover, saliva sampling may be done at any location and can be easily observed, if required.
Devices for collecting and analyzing saliva samples have been developed and introduced commercially. Such devices are generally divided into two types. The first type adopts a configuration wherein a collecting part is separated from the analyzing part. The second type adopts a configuration similar to a mid-stream urine pregnancy test, where samples are collected on a pad and delivered by capillary action to the testing channel in the same device.
However, the first type of devices requires multiple steps and may raise the issue of sample contamination. The second type of devices, which is a major improvement over the first type, is able to perform the sample collection and assay in one step. However, since the second type of devices has to serve both purposes of sample collecting and sample delivering, it requires a soft pad for collecting the sample and a rigid pad for delivering the sample to the testing channel. Further, since the pads cannot be squeezed, it needs a large liquid capacity with minimum retention volume. All these requirements render the designing and selection of padding materials difficult. In addition, since the testing device is attached to the collection pad, it is relatively inconvenient to handle the testing device and very likely to have fluids spilled over the whole device.
Accordingly, it is desirable and advantageous to develop a novel device, which have a separate section to implement sample collection independently and still maintains the functionality of one-step sample assay.
The present invention provides a device for collecting and analyzing a biological fluid. The device contains a sample collecting section having at least one collection pad for collecting a sample of the biological fluid, a sample accommodating section operatively engageable with the sample collecting section for extracting and accommodating the sampled collected by the sample collecting section, and a sample analyzing section, disposed within the sample accommodating section and having a sample analyzing means in fluid communication with the sample extracted and accommodated within the sample accommodating section.
In one aspect of the device, the sample collecting section contains a knob at the proximal end thereof for an operator to hold the sample collection section and an elongate shaft at the distal end therefore for attaching the collection pad. Preferably, the sample accommodating section contains a sample extracting means disposed within the sample accommodating section for engaging the collection pad and extracting the sample collected by the collection pad when the sample collecting section is operatively engaged with the sample accommodating section. Preferably, the sample extracting means contains a protrusion provided within the sample accommodating section and dimensioned to partly engage the collection pad to extract the sample from the collection pad when the sample collecting section is operatively engaged with the sample accommodating section. Preferably, the sample accommodating section has a lower inner surface, and the protrusion is formed on part of the lower inner surface to form a sample reservoir around the protrusion where the sample extracted by the protrusion is accommodated. Preferably, the sample analyzing means of the sample analyzing section is in fluid communication with the sample accommodated in the sample reservoir.
In another aspect of device, the sample collecting section contains an externally threaded portion and the sample accommodating portion contains an internally threaded portion engageable with the externally threaded portion.
In another aspect of the device, the device further contains an insulating means for securing the tight contact between the sample collecting section and the sample accommodating section when the sample collecting section and the sample accommodating section are engaged with each other.
In another aspect of the device, the analyzing means of the sample analyzing section contains a plurality of testing strips. Preferably, the sample analyzing section contains a sleeve with a plurality of grooves formed therein and each of the testing strips is slidably disposed within a corresponding groove.
In another aspect of the device, the sample accommodating section contains a transparent part for viewing the analyzing means of the sample analyzing section.
Although the device according to an exemplary embodiment of the invention will be described in connection with the collection and analysis of oral biological fluid such as saliva, it should be recognized that the application of the device is not limited to oral biological fluids. Rather, the device is applicable to any other suitable circumstances, where collection and analysis of any suitable biological fluids is required.
These and other features, benefits and advantages of the present invention will become apparent by reference to the following text figures, with like reference numbers referring to like structures across the views, wherein:
The present invention now will be described in detail hereinafter with reference to the accompanying drawings, in which preferred embodiments of the invention are shown. However, this invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Like numerals refer to like elements throughout.
As illustrated in
The elongated shaft 103 provides a structure for attaching a sample collection pad 300, which is normally made of sponge material. As shown in
Referring to
Referring to
As illustrated in
When the collection sample is squeezed out of collection pad 300 after protrusion 503 engages collection pad 300, the extracted sample flows into sample reservoir 504 due to the gravity of the sample. The reservoir provides a structure rendering fluid communication of the sample and the sample analyzing means of the sample analyzing section 400, which will be described below with reference to
In this exemplary embodiment of the device, sample analyzing section 400 is generally a hollow sleeve disposed within the sample accommodating section and through which shaft 103 and collection pad 300 pass. However, it should be recognized that the sample analyzing section could take any suitable shape and configuration to fulfill the functionality of sample analysis.
As illustrated in
Normally, when the sample is extracted from the collection pad 300 after the engagement of the collection pad 300 and the protrusion 503 and subsequently accumulated in the sample reservoir 504, the sample is absorbed by the analyzing strips 600, and consequently a series of immunoassays are performed. The assay usually can be accomplished within 10 minutes and the test results can be demonstrated by means of any physical or chemical changes of the trip that are perceptible or detectable by the operator.
For example, the sample accommodating section 500 may further includes a transparent portion, which provides a structure for viewing the testing results directly. In addition, an optional label 700 can be provided to cover the transparent portion before the assay of the sample and removed from the transparent portion to render an observing window after the assay of the sample. The label 700 can be utilized to provide information concerning the properties of the assay to be performed. For example, five DOA test strips are used for common drugs of abuse screen when conducting an on-site examination. When the fluid sample is negative for drugs abuse, each strip will generate a colored test line and a colored control line. In the event any of the testing drugs is presented in the sample fluid, the test line will be colorless on a specified analyzing strip. By reading the results through the transparent window of the sample accommodating section, a quick and accurate determination can be made on whether the sample donor has taken drugs and the type of the drugs.
In case that a quantitative test or a confirmation test is required, the on-site operator needs to send the remaining sample to a qualified lab for further analysis. The above exemplary embodiment of the invention is able satisfy the foregoing requirement. First, the sample absorbed by the analyzing strips does not backflow to reach the remaining sample collected in the collection pad and thus prevent the potential contamination of the remaining sample. Further, the device provides a leak-proof container for the sample fluid during the transportation of the sample. Thus, the change for the sample to spill over is minimized. In addition, since the only portion of the device that is touched by an operator is the lid, the chance for the operation to touch and smell the sample is also minimized, which improves the safety of the operator.
In an experiment, sample collection and analysis were performed on five volunteers, each of who rubbed his/her mouth with a collection pad for 5 minutes and then inserted the pad into the cylinder to initiate a sample assay by squeezing the collection pad. The immunoassay was completed within 10 minutes and the results were observed through the transparent window. The following Table 1 records the results. As a positive saliva control, an artificial saliva control containing a specified drug mixture at a concentration of two times of a specified cutoff value was used for demonstration, and five repetitive tests were performed by soaking a collection pad into the saliva control.
The invention has been described herein with reference to particular exemplary embodiments. Certain alterations and modifications may be apparent to those skilled in the art, without departing from the scope of the invention. The exemplary embodiments are meant to be illustrative, not limiting of the scope of the invention, which is defined by the appended claims.
