Strep A Rapid Test

The Strep A Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.

  • Sample : Throat Swab
  • Format : Cassette
  • Sensitivity : 97.4%
  • Specificity : 99.4%
  • Accuracy : 98.5%
  • Time to result : 5 minutes
Product Detail
Remark Specimen Format Cat. No.  Product
Strep A Throat Swab Strip HISTA-501 Strep A Rapid Test Strip
Cassette HISTA-502 Strep A Rapid Test Cassette



PRINCIPLE

The Strep A Rapid Test Device is a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab. In this test, antibody specific to Strep A carbohydrate antigen is coated on the test line region of the test. 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 color line in the test line region. The presence of this color line in the test line 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.

 

INTERPRETATION OF RESULTS




NOTE:
1、The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.
2、Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.

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As a professional IVD manufacturer, MOQ - Rapid Test: 1000 units; PCR: Negotiable.
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