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Manufacture rapid test strip, rapid test reader .

 

Fig. 1. Uniscan™: A 280 g handheld rapid test reader.

 

 

A platform to analyze all kinds of membrane-based lateral flow immunoassays

Fig. 2. Platform technology: Immunoassay rapid tests -> Uniscan™ -> Digital read-out results

 

 

 

Lateral flow membrane-based immunoassay for both sandwich and competitive methodology

Fig. 3. Lateral flow membrane-based immunoassay for both sandwich and competitive methodology.

 

 

 

A 600 dpi high resolution CIS is precisely controled by a stepper motor

Fig. 4. A 600 dpi high resolution CIS is precisely controled by a stepper motor.

 

 



Fig. 5. A data plot after signal processing guarantees high accuracy on its analysis. (c: control line; t1, t2, t3: test lines)

 

 

LCD screen shows digital read-out results of immunoassay test strips

Fig. 6. LCD screen shows date, time, serial number, panel number, analyte, concentration, and unit. (P4: progesterone)

 

 

 

Standard calibration strips corrcet Uniscan baselines

Fig. 7. Standard calibration strips calibrate Uniscan™ baselines.

 

 

Portable system with a rechargeable battery and a printer

Fig. 8. A convenient portable system with a rechargeable battery and a printer.

 

 

 

 

 

 

 

 

UNISCAN™ : Immunoassay Rapid Test Reader

 

A. Product Description

Digital read-out results

Uniscan™ is a 280 g, 20 cm x 10 cm x 3.5 cm (Fig. 1) handheld rapid test reader, designed to scan and provide rapid and objective digital read-out results for membrane-based lateral flow immunochromatographic assays. When read visually, these conventional rapid tests are at best semi-quantitative. When read by Uniscan™, however, those qualitative rapid tests can produce data that are as good as those produced by automated ELISA instruments and often better than those produced by manual analyses involving multiple pipettings and/or dilutions.

 

Platform technology

Uniscan™ serves as a platform capable to analyze all kinds of membrane-based lateral flow immunoassays (Fig. 2). By changing rapid tests made of different components (i. e., antibodies & antigens), Uniscan™ provides sensitive, accurate, multianalytes and reliable digital read-out results suitable for many immunoassay applications.

 

High throughput and easy to use

Uniscan™ is an easy-to-use random-access reader into which a rapid test strip can be inserted at any time. The simple operation procedures to analyze a developed rapid test involve: strip insertion, button pressing, scanning, data processing, strip withdrawal. An operation cycle time is approximately 15~20 seconds for analyzing one test strip. This short turn-around time guarantees a throughput reaching 180~240 test strips per hour.

 

Rapid test for multiple analytes

The rapid test used in the Uniscan™ bases upon a common lateral flow membrane-based type of configuration (Fig. 3): sample-loading pad, conjugate pad, nitrocellulose membrane, test lines, control line, and absorbent pad and are processed then assembled in a cassette (Fig. 2). The color substance accumulated in the test and control lines could be any chromogenic material, such as colloid gold, carbon nanoparticles, latex beads, and active dyes (please refer to the list of TUBI patents), etc. The rapid test strip is housing in a proprietary cassette which allows the sample to be analyzed by either a sandwich or a competitive immunoassay methodology. The current set-up of the cassette can accommodate up to three different analytes (three test lines) at a single strip detection.

 

High resolution CIS

Uniscan™ applies a linear contact image sensor (CIS) module to detect color density of a developed rapid test. A CIS module comprises a light emission diode (LED) array of light source and many small dot light sensors. The LEDs of CIS direct light to the surface of an inserted rapid test strip and the intensity of the reflected light from the strip is recorded by the CIS light sensors array. The intensity of the reflected light is related to color density, which is directly (or inversely) proportional to the concentration of analytes for a sandwich (or competitive) protocol. The reflected light intensity detected by the CIS sensors is then converted to voltages for a further signal processing. The characteristics of the CIS module used in the Uniscan™ are (1) yellow-green LEDs, (2) 600 dpi (dots per inch) high resolution, and (3) 2 ms/line fast scanning speed.

 

Stepper motor control

A modular CIS is mounted onto a stepper motor, which controls movement of CIS module while scanning (Fig. 4.). As moving across a cassette surface, the CIS module read 16 different signals from designated zone of a strip membrane. The average figure of the 16 positions is computed by a microprocessor to minimize the error caused by an uneven distribution of color substance in test and control lines. The CIS module records signals four times at each position, and the average value of the 4 data is obtained to minimize errors in the CIS components.

 

High accuracy signal processing

A typical data plot after signal processing by Uniscan™ 's microprocessor is presented in Fig. 5. The yellow line in Fig. 5 consists of about 500 dots read from CIS light sensors. Each dot on the yellow line is an average of 64 (= 16 position x 4 time) data. This indicates that the Uniscan™ performs with high accuracy on its analysis. The coefficient of variance (CV) of the Uniscan™ itself is only about 0.8%.

 

Other useful functions

The analyte concentration measured is computed automatically via a built-in calibration equation. The parameters of the calibration equation can be conveniently adjusted by users upon the cassette lot number changes. The LCD screen shows analyte concentrations, date, time, serial number, and panel number (Fig. 6). These data are automatically saved in the memory of the device with a maximum of 135 rapid test results of memory space. Through a RS-232 connector the saved results in the reader can either be printed out by a printer or can be downloaded to a computer for further data saving or analyzing. To minimize the components variation between one reader and another, a set of standard calibration strips is provided, consisting of a cassette with a white membrane strip and a cassette with a black membrane strip (Fig. 7). Thereby, the reader backgrounds could be corrected after a device has been used for an extended period of time. A convenient portable system with a rechargeable battery and a printer is also available (Fig. 8) for using in a place without electricity.

Applications

Uniscan™ has been successfully applied to detect:

•  Progesterone (P4)

•  Foot-and-mouth disease (FMD)

•  Drugs of abuse (DOA)

•  Prostate specific antigen (PSA)

 

Increasing competitiveness for rapid test manufacturers

Uniscan™ provides digital read-out platform to analyze all kinds of membrane-based lateral flow immunoassays. For rapid test manufacturers to significantly increase their competitiveness of traditional qualitative analysis based immunoassay, an important method is to provide digital analysis for customers by applying an accurate and reliable platform. The world-leading technology of Uniscan™ is certainly the best choice.

 

 

B. CE Certificate

1. Certificate of EMC Compliance (Certificate No.: EM/2006/50052)

C. Awards

1. The WIPO Award for the Best Inventor (2007) - DoA Mobile Laboratory

2. Gold Medal of National Exhibition of Inventions (2007, China) - DoA Mobile Laboratory

3. The 13th (2006) Taiwan SMEs Innovation Award. " A practical platform commomly used in immunoassay quantitation"

4. Innovative Product Awards 2005, Hsinchu Science Park. "A Reliable Handheld Quantitative Point-of Care Testing, POCT, Immunoanalyzer"

 

D. Patent

1. Quantitative scanning analyzer unit, 7,002,687/2006 USA  

2. Quantitative scanning analyzer unit, I245899/2005 ROC

3. Quantitative scanning analyzer unit, pending/2003 PRC

4. Detection component and strip cassette, M303000/2006 ROC

 

E. Contact Us

Tel: +886 (37) 586345
Fax: +886 (37) 586329

E-mail: kphsiung@tubi.com.tw

 




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