Accutest® ValuPak™ Strep A Test Strip – CLIA Waived (25 Tests/Kit)
$29.00
5-Minute Results
25 Tests per Kit
25 tests per kit
$1.16 per test
Rapid Strep A test for the qualitative detection of Group A Streptococcus antigen in throat swab specimens from symptomatic patients. This CLIA-waived test provides results in 5 minutes.
- Qualitative detection of Group A Streptococcus antigen
- Uses throat swab specimens
- Results in 5 minutes
- Includes positive and negative external controls
| 1-5 | 6-10 | 11+ |
| $29.00 | $26.68 | $25.23 |
Accutest® ValuPak™ Strep A Test Overview
The Accutest® ValuPak™ Strep A Test is a rapid chromatographic immunoassay for the qualitative detection of Group A Streptococcus (Strep A) antigen in throat swab specimens from symptomatic patients. This CLIA-waived test provides results in 5 minutes and is intended for prescription, professional in vitro diagnostic use. Each kit contains 25 tests.
5-Minute Results
Throat Swab
25 Tests per Kit
Features and Benefits
CLIA-waived rapid Strep A testing
Qualitative detection of Group A Streptococcus antigen
Uses throat swab specimens from symptomatic patients
Results available in 5 minutes
Includes positive and negative external controls
Built-in procedural control helps verify proper test performance
25 individually packaged test strips per kit
Convenient 2–30°C (36–86°F) storage
ID713
DTK-101517
Clinical Performance
Clinical performance of the Accutest® ValuPak™ Strep A Test was evaluated using 533 throat samples from symptomatic subjects and compared with bacterial culture.
| Performance Measure | Result |
|---|---|
| Sensitivity | 96.5% (110/114) |
| Specificity | 99.5% (417/419) |
Kit Contents
| Component | Quantity |
|---|---|
| Test Strips | 25 |
| Sterile Swabs | 25 |
| Disposable Extraction Tubes | 25 |
| Reagent A | 1 × 10 mL |
| Reagent B | 1 × 10 mL |
| Positive Control | 1 |
| Negative Control | 1 |
| Tube Holders | 2 |
Basic Test Procedure
- Collect the throat swab specimen according to the package insert.
- Add 4 drops of Reagent A and 4 drops of Reagent B to the extraction tube and mix the solution.
- Place the throat swab into the extraction tube and rotate the swab approximately 10 times.
- Leave the swab in the extraction tube for 1 minute.
- Remove the swab while squeezing the sides of the tube to extract as much liquid as possible.
- Place the test strip into the extracted specimen with the arrows pointing toward the specimen.
- Read the result at 5 minutes. Follow the package insert for complete result interpretation instructions.
Always follow the current package insert and procedure card supplied with the exact product lot.
Instructions and Documents
Frequently Asked Questions
What does the Accutest ValuPak Strep A Test detect?
The test qualitatively detects Group A Streptococcus (Strep A) antigen in throat swab specimens from symptomatic patients.
Is the Accutest ValuPak Strep A Test CLIA-waived?
Yes. ID713 is a CLIA-waived rapid Strep A test intended for prescription, professional in vitro diagnostic use.
How quickly are results available?
Results are read at 5 minutes. Follow the package insert for the complete testing procedure and result interpretation.
What type of specimen does the test use?
The Accutest ValuPak Strep A Test uses throat swab specimens from symptomatic patients.
How many tests are included in each kit?
Each kit contains 25 individually packaged Strep A test strips along with sterile swabs, extraction tubes, reagents and external controls.
Does the kit include external controls?
Yes. Each kit includes a positive control and a negative control.
What are the sensitivity and specificity of the test?
In the clinical study described in the package insert, the test demonstrated 96.5% sensitivity and 99.5% specificity compared with bacterial culture.
Can this Strep A test be used at home?
No. The Accutest ValuPak Strep A Test is intended for prescription, professional in vitro diagnostic use and is not an over-the-counter home test.
Additional information
| Weight | 1 lbs |
|---|
