Tuberculosis (IgG&IgM&IgA) W/S/P Test Card

Tuberculosis (IgG&IgM&IgA) W/S/P Test Card

INTENDED USE

Tuberculosis (IgG&IgM&IgA) W/P/S Test Card is a rapid chromatographic immunoassay for the qualitative detection of anti-TB (M.tuberculosis, M. bovis and M. africanum) antibodies (all isotypes: IgG, IgM, IgA, etc.) in human whole blood, serum or plasma.
 
SUMMARY
 
Tuberculosis (TB) is spread primarily via airborne transmission of aerosolized droplets developed by coughing, sneezing and talking. Areas of poor ventilation pose the greatest risk of exposure to infection. TB is a major cause of morbidity and mortality worldwide, resulting in the greatest number of deaths due to a single infectious agent. The World Health Organization reports that more than 8 million new cases of active tuberculosis are diagnosed annually. Almost 3 million deaths are attributed to TB. Timely diagnosis is crucial to TB control, as it provides early initiation of therapy and limits further spread of infection. Several diagnostic methods for detecting TB have been used over the years including skin test, sputum smear, sputum culture and chest x-ray. But these have severe limitations. Newer tests, such as PCR-DNA amplification or interferon-gamma assay, have been recently introduced. However, the turn-around time for these tests is long. Because of the requirement of laboratory equipments and skilled personnel, these new methods are not cost effective and may not be practical in rural area or developing countries.
 
Serological methods constitute an attractive alternative as it is simple, inexpensive and non-invasive. The Rapid Tuberculosis (TB) Test is a rapid test to qualitatively detect the presence of anti-TB (M. tuberculosis, M. bovis and M.africanum) antibodies (all isotypes: IgG, IgM, IgA, etc.) in human whole blood, serum or plasma specimen. The test utilizes a combination of recombinant antigens to selectively detect elevated levels of anti-TB antibodies in whole blood, serum or plasma.
 
PRINCIPLE
 
Tuberculosis (IgG&IgM&IgA) W/P/S Test Card IS a qualitative, solid phase, two-site sandwich immunoassay for the detection of anti-TB antibodies in whole blood, serum or plasma. The membrane is pre-coated with TB recombinant antigen on the test line region of the Device. During testing, Serum or plasma specimen reacts with the particle coated with TB recombinant antigen. The mixture migrates upward on the membrane chromatographically by capillary action to react with TB recombinant antigen on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
 
PRECAUTIONS
 

• For professional in vitro diagnostic use only. Do not use after the expiration date.
• Do not eat and drink in the area where the specimens or kits are handled.
• Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.

• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are being tested.
• Once taking the test card out of the pouch, carry out your testing as quickly as possible (no more than 20 minutes) to avoid moisture. The nitrocellulose membrane can absorb water, which can affect the test chromatography performance.
• The used test should be discarded according to local regulations.

 
 
STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (4-30°C). The test device is stable through the expiration date as printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE.
Do not use beyond the expiration date.
 
SPECIMEN COLLECTION AND PREPARATION

• The Tuberculosis (TB) Test Card can be performed using whole blood, serum or plasma specimen. The specimen should be collected under standard laboratory conditions.
• Patient samples are performed best when tested immediately after collection. Specimen may be stored, if the sample cannot be tested within 24 hours. The red blood cells should be removed to avoid hemolysis. Serum or plasma should be frozen until the test can be performed. Whole blood samples should be refrigerated at 2–8°C, instead of being frozen. Allow sample to reach room temperature before proceeding.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
• The shipping of the specimens should compliance with the guidelines of transportation of etiologic agents.

 
MATERIALS PROVIDED
1. Rapid Tuberculosis (TB) Test Card individually foil pouched with a desiccant.
2. Transfer pipet.
3. Instructions for use
 
TEST PROCEDURE
1. Bring all materials and specimens to room temperature.
2. Remove the test device from the sealed foil pouch, place the test device on a flat horizontal surface and label the test device with specimen identity.
3. Using the transfer pipet to draw up the sample, dispense 2 drops (80-100 ml) of sample in a vertical position into the each sample well individually. See illustration below.
4. Read the result at 15 minutes after adding the sample. Do not interpret the result after 30 minutes
 
INTERPRETATION OF RESULTS
POSITIVE: Two distinct colored lines appear. One line should be in the control region (C) and another line should be in the test region (T).
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test Device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
 
 
NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of anti-TB antibodies present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive
 
QUALITY CONTROL
A procedural control is included in the test. A colored line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit.
 
LIMITATION
Tuberculosis (IgG&IgM&IgA) W/P/S Test Card is for in vitro diagnostic use only. The test should be used for the detection of anti-TB antibodies in whole blood/serum/plasma specimen. Neither the quantitative value nor the rate of anti-TB antibodies concentration can be determined by this qualitative test.
Tuberculosis (IgG&IgM&IgA) W/P/S Test Card will only indicate the presence of anti-TB antibodies in the specimen and should not be used as the sole criteria for the diagnosis of active tuberculosis diagnosis.
As with all diagnostic tests, all results must be considered with other clinical information available to the physician.

 
Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10^th and 11^th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
 
Our mission:
 

• Always best of all and always pay attention to innovation.
• Special customized service tightly following customers’ requests.
• Integrated excellent quality, competitive prices and super service together.