Rapid streptococcus A test ISA-502

for infectious diseasesfor respiratory infectionsthroat

Product Description
The Strep A Rapid Test Device (Throat Swab) 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.

Kit Components

• Test devices
• Sterile swabs
• Strep A Reagent A (1M Sodium Nitrite)
• Strep A Positive control (Non-viable Strep A; 0.09% NaN3)
• Workstation
• Test tubes
• Strep A Reagent B (0.4M Acetic Acid)
• Strep A Negative control (Non-viable Strep C; 0.09% NaN3)
• Dropper tips
• Package insert

Product table (relevant row)
Product | Item No. | Description | Specimen
Strep A | ISA-502 | Strep A test | throat swab

Additional Information
The device is a rapid chromatographic immunoassay intended to aid in the diagnosis of Group A Streptococcal infection by qualitative detection of Strep A antigen from throat swab specimens. The test uses antibody-coated particles and membrane-immobilized antibody to produce a visible color line for positive results and includes a control line as procedural control.

Technical specifications

• Test type: Qualitative lateral flow immunoassay (rapid chromatographic immunoassay)
• Target analyte: Strep A carbohydrate antigen
• Specimen type: Throat swab
• Model / Item No.: ISA-502
• Controls included: Positive control (non-viable Strep A) and Negative control (non-viable Strep C)
• Key reagents: Reagent A (1M Sodium Nitrite), Reagent B (0.4M Acetic Acid)
• Kit components: Test devices, sterile swabs, reagents, controls, workstation, test tubes, dropper tips, package insert