Product Specifications
| Prod Model: |
SM-DG04 |
| Markets: |
North America,South America,Eastern Europe,Southeast Asia,Africa,Oceania,Mid East,Eastern Asia,Western Europe |
| Size: |
2.5mm, 3.0mm |
| Usage: |
Tuberculosis Test |
| Packaging: |
1test/Pouch |
| Accuracy: |
>99.5% |
| Shelf Life: |
2 Years |
| Classification: |
Biological Diagnostics |
| Type: |
Biochemistry Analyzer |
| Certification: |
ISO13485 |
| Group: |
All |
Product Description
Product Description
INTENDED USE
The TB Rapid Test is a chromatographic immunoassay (CIA) for direct qualitative detection of Tuberculosis antibody in human serum or plasma.
PROCEDURE
1. Open a pouch containing a cassette and lay the cassette on a flat surface.
2. Carefully apply 4UL of sample onto the light blue line (sample indicating line) printed on the center area of membrane as illustrated in figure 1:
Note: Do not overload sample, 4UL is enough.
Do not scratch the membrane.
3. Wait one minute and let sample solution absorb on the membrane.
4. Add two drops (40-80UL) of chasing buffer into the sample well (S).
5. Read the result in 15 minute
INTERPRETATION OF RESULTS
1. Negative: Only one pink band appears control region (C), no band in test region (T). This indicates that there is no detectable TB antibody in the specimen.
2. Positive: Two pink bands appear on both test region and control region. This indicates that the specimen contains detectable amount of TB antibody.
3. Invalid: If no band appears in the control region(C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.
Sensitivity: 98.9%
Specificity: 91.5%
Jiaxing Smir Medical Devices Co., Ltd provides vitro diagnostic (IVD) rapid testsystems. Including fertilities test(HCG, LH, Torch, etc), infectious diseases(HBsAg, HIV, HCV, Dengue, Malaria, etc), HBV, drug of abuse(MOR, MET, AMP, BZO, etc), Alcohol Saliva Test Strip, Urine Strip, H. Pylori, Chlamydia, Syphilis, ELISA etc.
| Format | Specimen | Size(mm) |
| Strip | whole blood/serum | 2.5,3.0 |
| Cassette |
| Strip | serum/plasma | 2.5,3.0 |
| Cassette |
Jiaxing Smir Medical Devices Co., Ltd is a professional disposable medical devices company that has been serving domestic and overseas markets for 12 years since 2001.
Jiaxing Smir Medical Devices Co., Ltd has earned the trust from the customers on overseas markets, such as UK, Spain, Denmark, Netherland etc in Europe; Japan, Malaysia, Philippine, Thailand etc in East Asia; Tanzania, Mauritius, South Africa etc in Africa; Iran, Lebanon, Iraq etc in Middle East.
We offer a wide variety of medical products and supplies to select from so you may choose which product best fits your needs. We provide prompt shipping with each order and guarantee timely delivery. Our expert staffs take the time to give each of our customers the personal attention he or she deserves. We strive to always provide the highest level of service and care possible.
Satisfaction is our main priority and we strive to ensure our customers needs are met efficiently and professionally
