Strep A Rapid Test

Strep A Rapid Test

Strep A Rapid Test (Swab) is a rapid visual immunoassay for the qualitative, presumptive detection of Group A Streptococcus antigens in human throat swab specimens. Strep A Rapid Test is intended for use as an aid in the diagnosis of Strep A infection.

Description

Intended Use:

Strep A Rapid Test (Swab) is a rapid visual immunoassay for the qualitative, presumptive detection of Group A Streptococcus antigens in human throat swab specimens. Strep A Rapid Test is intended for use as an aid in the diagnosis of Strep A infection.


Materials

● Individually packed test devices

● Reagent 1

● Reagent 2

● Positive control

● Negative control

● Sterilized swabs

● Disposable pipettes

● Extraction tubes

● Workstation

● Package insert


Product Features

STA: Strep A swab(cassette)

Immunochromatography based one-step in virto diagnostic test

Specimen: Swab

Reading Time: 5 mins

Storage: 2-30°C

Kit package: 20 pcs


Procedure

Bring tests, specimens, reagents and/or controls to room temperature (15~30°C) before use.

1. Prepare swab specimens:

● Place a clean extraction tube in the designated area of the workstation. Add 4 drops of reagent 1 to the extraction tube, and then add 4 drops of reagent 2. Mix the solution by gently swirling the extraction tube.

● 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, and 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.

2. 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.

3. Add 3 drops (approximately 120 µL) of extracted solution with disposable pipettes from the extraction tube to the sample well on the test device.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the observation window.

As the test begins to work, color will migrate across the membrane.

4. Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.


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