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RAPID TESTS: STREPTOP A

>TEST >REF.
S D M
Packaging CE mark Sensitivity Specificity Total running time
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STREPTOP A 5443
In bulk CE mark 96,8 % 94,7 % 3 h 15.
  • FORMAT: S: stick; D: device; M: midstream,
  • All the tests are packaged in individual, aluminium, hermetic pouch.

Bacteriology

STREPTOP A

Immunochromatographic rapid dipstick test for the detection of Strep A antigen in throat swabs specimens to aid in the diagnosis of group A streptococcal infection.

- RELIABLE :
- Quality system certified ISO 9001 and ISO 13485.
- Performances according to the AFSSAPS (*) recommendations.
- Performances comparable with culture methods : 499 tested patients.
-------- sentitivity : 96.8%, specificity : 94.7%,
-------- negative PREDICTIVE value : 98.9 %.
- Quality control : control + and control – provided.

- PRACTICAL :
- Tracability : possible strip archiving.
- Long shelf life : 18 months.

- PACKAGING :
- Kit of 20 tests.
- Provided swabs.

- FAST :
- three steps are enough :
-------1 - Take a troat sample,
-------2 - Extraction of the antigen,
-------3 - Deposit the strip in the extraction tube.
- Rapid results : available in 5 minutes.



STREPTOP A® is an immunochromatographic test on a membrane, using the sandwich capture method. An anti-streptocoque A antibody is fixed on to the membrane’s test region. A second anti-streptocoque A antibody is conjugated to purplelatex particles and placed just over the membrane’s immersion zone. The presence of a purple line at the test zone level, indicates a positif result, whereas no purple line indicates a negative result. The purple line at the control level, indicates that the test was functional.


INDICATIONS

Only the patients afflicted with an accute angina with group A streptocoques are justifiable for an antibiotic treatment. STREPTOP A® enables to determine with accuracy, the streptococcic origin of an angina.using it systematically, when confronted with any type of angina enables to prescribe the rational amount of antibiotics and contributes to fight efficientlyagainst antibiotic resistance.
The STREPTOP A® test is a qualitative, lateral flow immunoassay for the detection of Strep A antigen in a throat swab. In this test, antibody specific to Strep A antigen is coated on the test line region of the strip. During testing, the extracted throat swab specimen reacts with an antibody to Strep A that is coated onto particles. The mixture migrates up the membrane to react with the antibody to Strep A on the membrane and generate a red line in the test region. The presence of this red line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a red line will always appear in the control region if the test has been performed properly.  If a red control line does not appear, the test result is not valid.

Streptococus pyogenes which contains the lance field group A antigen that can cause serious infections such as pharyngitis, respiratory infection, endocarditis, meningitis and arthritis. Rapid diagnosis and early antibiotic therapy of groupe A Straptococcal infection appear to be the best means of preventing medical complications and reducing the spread of the disease.




STREPTOP A


PROCEDURE


INTERPRETATION




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