The Strep A Rapid Test is a quick and reliable diagnostic tool designed to detect Strep A antigens from throat swab samples. It helps identify Group A Streptococcal infections efficiently, providing fast results with a simple and equipment-free procedure.
With easy-to-read visual indicators and high accuracy, this test is ideal for use in clinics, schools, and other point-of-care settings where swift diagnosis is essential.
- Fast results
- Easy visual interpretation
- Simple operation, no equipment required
- High accuracy
Reading Results
POSITIVE:
Two colored lines will appear: one in the control line area (C) and one in the test line area (T). This means Strep A has been detected.
Note: The color intensity of the test line (T) may vary depending on how much Strep A is in the sample.
NEGATIVE:
Only one colored line appears in the control line area (C), with no line in the test line area (T). This means either there is no Strep A in the sample, or the amount is too low for the test to detect. A follow-up culture is recommended to confirm the absence of infection. If the result doesn’t match the patient’s symptoms, consider collecting a new sample for culture.
INVALID:
If the control line (C) does not appear, the test is invalid. This is usually due to too little sample or an error in the testing process. Review the instructions and repeat the test with a new device. If the
issue continues, stop using the test kit and contact your supplier.
Instructions
Before you begin, allow the test, reagents, and specimen to reach room temperature (15–30℃).
1. Open Test Kit:
Use the test strip within 1 hour of opening the foil pouch for best results.
2. Prepare Extraction Solution:
a. Add 4 drops (240 μL) of red Extraction Reagent 1 into the extraction tube.
b. Add 4 drops (160 μL) of colorless Extraction Reagent 2.
c. Swirl to mix; the solution should turn yellow.
3. Add Sample:
a. Insert the swab into the tube. Swirl vigorously 15 times.
b. Leave swab in the tube for 1 minute.
4. Remove Swab:
a. Press swab against the tube to extract liquid. Discard swab.
5. Apply Sample to Test Strip:
a. Attach the dropper tip.
b. Add 3 drops (about 100 μL) into the sample well (S).
c. Start timer.
6. Read Results:
a. Check at 5 minutes.
b. Do not interpret results after 10 minutes.
Note: Do not use the buffer more than 6 months after opening.
Results Interpretation
Positive: Two lines — one at control (C) and one at test (T). Color intensity may vary.
Negative: One line at control (C); no line at test (T). Follow up with a throat culture if symptoms persist.
Invalid: No control line. Repeat test with a new kit. Contact supplier if issue continues.
Intended Use
The Strep A Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of
Strep A antigens in throat swab specimens collected from individuals with signs and symptoms of
pharyngitis.
The Strep A Rapid Test is intended for use by healthcare professionals and laboratory personnel as
an in vitro diagnostic tool to help detect Group A Streptococcal infections. It provides preliminary
results; however, a negative result does not rule out a Strep A infection and should not be the only
basis for diagnosis or treatment decisions.
Not for self-testing use
Michelle L., Nurse, Toronto –
As a school nurse, getting clear results in 5 minutes brings such peace. No guessing, no delays—just swift action
Dr. Alan R., Family Physician, Vancouver –
This test has saved our clinic hours of waiting. It gives us quick answers and brings reassurance to anxious parents almost instantly
Sarah D., Pediatrician, Calgary –
It’s comforting to know within minutes whether it’s strep. Parents walk out relieved and thankful—we feel more confident with every test.
Jason M., Clinic Manager, Ottawa –
No machines, no fuss—just accurate results in five minutes. These kits have made diagnosing sore throats in our walk-in so much easier
Dr. Priya N., General Practitioner, Montreal –
During flu season, this test is a real peace of mind. We can rule out strep fast and move ahead with treatment confidently.