Insert

Strep A

Immunoassay for the detection of Group A streptococcus antigen directly from throat swab specimens.

• Easy to use flip step eliminates need for pipetting.
• Fast, accurate detection of Group A Strep with "walk-away" convenience
• Results in 5 minutes
• Sensitivity of 96.2% and Specificity of 98.7%

Test Device

Procedure

1. Add 4 drops of Reagent A into Extraction Well.

2. Add 4 drops of Reagent B into Extraction Well.

3. Place the specimen swab in Swab Stand in Extraction Well.

Hold the device with one hand and the swab with the other. While pressing down on the swab, spin it in one direction about 5 times to mix the specimen.

4. Incubate 2-5 minutes with the swab in Extraction Well.

5. Hold the device with one hand and the swab with the other. While pressing down on the swab, spin in in one direction about 5 times to mix the specimen. Remove the swab and discard.

6. Raise the device upright.

7. Tap the device on a flat surface to ensure that the liquid flows into the hole.

8. Slowly lay the device back down onto flat surface.

9. Read test results after 5 minutes but not after 10 minutes.

Interpretation Of Results

Two Lines Positive (+)

Any visible T line is positive

C Line only Negative (-)

No C Line Invalid

Repeat with new sample and device