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

l  For professional in vitro diagnostic use only. Do not use after the expiration date.

l  Do not eat and drink in the area where the specimens or kits are handled.

l  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.

l  Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are being tested.

l  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.

l  The used test should be discarded according to local regulations.

Contact  Rebecca Yan 

Skype: span.biotech

Email: rebecca@spanbio.com

Tel:  +86(755)89589611

Web:

www.spanbiotech.com

 

Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th 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.
Efficiently structured to provide lasting and economic health care solutions with export ready goods, our main products cover the following immunodiagnostic rapid test kits:
Rapid Tests for Human Use :
1) Fertility: Pregnancy HCG, ovulation LH, menopause FSH
2) Infectious diseases: Hepatitis B, HCV, HIV
3) Drug abuse: AMP, BAR, BZO, COC, mAMP, MOP, MTD, OPI, PCP, TCA, THC
4) Tumor markers: CEA, PSA, AFP, FOB
5) STDs(Sexually Transmitted Diseases): Gonorrhea, syphilis, chlamydia
6) New products: Malaria, H. Pylori, Multi-Hepatis B Panel (HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc), Blood Glucose Test, Multi-drug of Abuse Panel, Avian (Bird) Flu Rapid Test, etc.
Rapid Tests for Veterinary :
1) Bovine: Cow Pregnancy , Cow Ovulation, Bovine Brucella, Bovine Tuberculosis ,Food and Mouth Disease NSP Ab Test
2) Canine: Canine Distemper, Canine Parvovirus, Canine Coronavirus
3) Feline : Feline Leukemia Virus Ag Rapid Test ,Feline Panleucopenia Virus Ag Test,Feline Immunodeficiency Virus Ab Test
Rapid Tests for Food Safety :
1)For Antibiotics Residue : Nitrofurans (AOZ,AMOZ, AHD, SEM), Streptomycin , Sulfonamides , Chloramphenicol , Quinolone , Beta-Lactam&Tetracycline Combo (2 in 1), β-Lactams & Streptomycin & Chloramphenicol & Tetracyclines Combo (4 in 1), Beta-Lactam, Tetracycline test
2) For Beta-Agonist Residue : Ractopamine, Clenbuterol ,Salbutamol