Product Overview
The Accutest® VALUPAK™ Strep A Test Strip is a rapid chromatographic immunoassay for the qualitative detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus) antigen in throat swab specimens from symptomatic patients. The test is intended to aid in the diagnosis of Group A Streptococcal bacterial infection.
A throat swab specimen is treated with Reagent A and Reagent B in the provided extraction tube. The test strip is then placed into the extracted specimen, and results are read at 5 minutes. A colored control line confirms that the test has performed correctly, while the appearance of both a control line and a test line indicates a positive result.
Negative results are presumptive and should be confirmed by bacterial culture. Test results should be evaluated together with the patient’s symptoms and other clinical information.
5-Minute Results
Rapid qualitative detection of Group A Streptococcal antigen.
CLIA Waived
Designed for testing in eligible CLIA-waived healthcare settings.
25 Tests per Box
Includes test strips, swabs, extraction tubes, reagents and external controls.
Key Features
- Rapid qualitative detection of Group A Streptococcal antigen
- Results read at 5 minutes
- CLIA waived
- Convenient test strip format
- Uses direct throat swab specimens from symptomatic patients
- 96.5% sensitivity and 99.5% specificity*
- Positive and negative external controls included
- Storage at 2–30°C (36–86°F)
*Compared with bacterial culture in the clinical performance study. Refer to the package insert for complete performance data, limitations, warnings and instructions.
Product Specifications
| Catalog Number | ID713 |
|---|---|
| Product Name | Accutest® VALUPAK™ Strep A Test Strip |
| Intended Use | Qualitative detection of Group A Streptococcal antigen |
| Specimen Type | Direct throat swab from symptomatic patients |
| Test Format | Test strip |
| Result Time | Read at 5 minutes; do not read before 5 minutes or after 10 minutes |
| CLIA Complexity | Waived |
| Regulatory Use | Prescription, in vitro diagnostic use only |
| Sensitivity | 96.5% |
| Specificity | 99.5% |
| Storage | 2–30°C (36–86°F); do not freeze |
| Package Size | 25 tests per box |
| FDA 510(k) | K212623 |
Kit Contents
- 25 test strips
- 25 sterile swabs
- 25 disposable extraction tubes
- Reagent A
- Reagent B
- Positive external control
- Negative external control
- Two tube holders
- Instructions for Use
- Quick Reference Instructions
How the Test Works
The Accutest® VALUPAK™ Strep A Test Strip is a qualitative lateral flow immunoassay that uses antibodies to detect Group A Streptococcal antigen in throat swab specimens.
- A throat swab specimen is collected using the sterile swab included in the kit.
- The specimen is extracted using Reagent A and Reagent B in the provided extraction tube.
- The test strip is placed into the extracted specimen.
- Results are read visually at 5 minutes.
A visible control line indicates that the test has performed correctly. The appearance of both a control line and a test line indicates a positive result. If the control line does not appear, the result is invalid and the test should be repeated with a new test strip.
Important Test Information
- For prescription, in vitro diagnostic use only.
- Use only the sterile swabs and reagents provided with the kit.
- Read results at 5 minutes. Do not read results before 5 minutes or after 10 minutes.
- Negative results are presumptive and should be confirmed by bacterial culture.
- All results should be interpreted together with the patient’s symptoms and other available clinical information.
Documentation and Resources
Review the official product instructions before performing the test.
Quick Reference Instructions Package Insert CDC Group A Strep InformationFrequently Asked Questions
The test qualitatively detects Streptococcus pyogenes, or Group A β-hemolytic Streptococcus, antigen in throat swab specimens from symptomatic patients.
The test is intended for use with direct throat swab specimens collected using the sterile swabs included in the kit.
Results are read at 5 minutes. Results should not be read before 5 minutes or after 10 minutes.
Yes. The Accutest® VALUPAK™ Strep A Test Strip is categorized as CLIA waived. A Certificate of Waiver is required to perform the test in a CLIA-waived environment, and the manufacturer’s instructions must be followed.
Each kit includes 25 test strips, 25 sterile swabs, 25 disposable extraction tubes, Reagent A, Reagent B, positive and negative external controls, two tube holders, Instructions for Use and Quick Reference Instructions.
Store the kit in its original packaging at 2–30°C (36–86°F). Do not freeze any of the test components. Test strips must remain in their sealed pouches until use.
A negative result means that Group A Streptococcal antigen was not detected in the specimen. Negative results are presumptive and should be confirmed by bacterial culture.
No. The package insert identifies the Accutest® VALUPAK™ Strep A Test Strip as a prescription, in vitro diagnostic product.
Ordering Information
You may place an order by giving us a call
| Catalog Number | Description | Package Size |
|---|---|---|
| ID713 | Accutest® VALUPAK™ Strep A Test Strip | 25 tests/box |
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