Audited Supplier
HSTR034GA
Detection Card
None
None
None
None
5-10 Minutes
3~5days After Get Payment
T/T, Western Union, Paypal
Accpet
PETX
Carton
10Tests/Kit
Hangzhou
38220010
Product Description
INTENDED USE
The Strep A Antigen Rapid Test is arapid chromatographic immunoassay for the qualitative detection of Group A Streptococcal antigen in human throat swab specimen. This kit is intended for use as an aid in the diagnosis of Strep A infection.
SUMMAR
MATERIALS
Materials Provided
| Each test contains colored conjugates and reactive reagents precoated at the corresponding regions. |
| 1.0 M sodium nitrite |
| 0.4 M acetic acid |
| Non-viable Strep A; 0.09% sodium azide |
| For specimen collection |
| For adding specimens |
| For specimen preparation |
| Workstation |
| For operating instructions |
Materials Required but Not provided
|
TEST PROCEDURE
Bring tests, specimens, reagents and/or controls to room temperature (1530°C) before use.- Prepare swab specimens:
• Immediately immerse the swab into the extraction tube. Use a circular motion to roll the swab against the side of the extraction tube so that the liquid is expressed from the swab and can reabsorb.
• Let stand for 1-2 minutes at room temperature, then squeeze the swab firmly against the tube to expel as much liquid as possible from the swab. Discard the swab following guidelines for handling infectious agents.
- Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
- Add 3 drops (approximately 75 µL) of extracted solution with disposable pipettes from the extraction tube to the sample well on the test device.
As the test begins to work, color will migrate across the membrane.
- Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:Sensitivity and Specificity
Relative Sensitivity: 94.93% (95%CI: 89.72%~97.71%)
Relative Specificity: 97.46% (95%CI:95.17%~98.73%)
Accuracy: 96.75% (95%CI:94.74%~98.03%)
Cross-Reactivity
Cross-reactivity studies with organisms likely to be found in the respiratory tract were also performed using the test. The following organisms were tested at 1×108 organisms/test, and all yielded negative results.
POL Studies
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:
- The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
- Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
PERFORMANCE CHARACTERIST
Sensitivity and Specificity
To determine the analytical sensitivity of the test, Group A Streptococcus bacteria organisms were grown by standard culture techniques. The detection limit of the Strep A Antigen Rapid Test was determined to be 1.5×105 organisms per test.
To determine the specificity of the test to Group A Streptococcal bacteria, the following Group A Streptococcal Strains were examined at different levels of organisms per test. Positive results obtained at a level of 1.5×105 organisms/test for all strains indicate that the test is sensitive to Group A Streptococcal bacteria.
Group A Streptococcal Strains:
SS-091 SS-410 SS-492 SS-496
SS-633 SS-634 SS-635 SS-721
SS-754 SS-799 ATCC-19615
Correlation Study
Table: Strep A Antigen Rapid Test vs. Culture
| Method | Culture | Total Results | ||
| Strep A Antigen Rapid Test | Results | Positive | Negative | |
| Positive | 131 | 9 | 140 | |
| Negative | 7 | 345 | 352 | |
| Total Result | 138 | 354 | 492 | |
Relative Specificity: 97.46% (95%CI:95.17%~98.73%)
Accuracy: 96.75% (95%CI:94.74%~98.03%)
Cross-Reactivity
Cross-reactivity studies with organisms likely to be found in the respiratory tract were also performed using the test. The following organisms were tested at 1×108 organisms/test, and all yielded negative results.
| Group B Streptococcus | Group C Streptococcus | Group D Streptococcus |
| Group F Streptococcus | Group G Streptococcus | Pseudomonas aeruginosa |
| Streptococcus bovis | Staphylococcus aureus | Proteus vulgaris |
| Streptococcus faecalis | Staphylococcus epidermidis | Escherichia coli |
| Streptococcus faecium | Staphylococcus saprophhyticus | Corynebacterium diphtheria |
| Streptococcus mitis | Neisseria gororrhoeae | Haemophilus parahaemolyticus |
| Streptococcus mutans | Neisseria lactima | Bordetella pertussis |
| Streptococcus pneumoniae | Neisseria meningitidis | Moraxella catarrhalis |
| Streptococcus salivarius | Neisseria sicca | Candida albicans |
| Streptococcus sanguis | Neisseria subflava |
