SKU: ID713
UNIT
QUANTITY
Box
1 Box (25 Tests/Box)
ID713
Accutest VALUPAK, Strep A Test Strip (ID713) 1 Box, 25 Tests/Box
**This item is intended for professional use only and are not approved for personal use or ship to a residential address. At checkout, please provide a medical / healthcare practice name and address for order processing.**
The Accutest® VALUPAK™ Strep A Test Strip is a CLIA-waived rapid immunoassay for the qualitative detection of Group A Streptococcal antigen in throat swab specimens from symptomatic patients. This convenient strip-format test provides results in 5 minutes and includes 25 tests per box. Negative results are presumptive and should be confirmed by bacterial culture.
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.
Rapid qualitative detection of Group A Streptococcal antigen.
Designed for testing in eligible CLIA-waived healthcare settings.
Includes test strips, swabs, extraction tubes, reagents and external controls.
*Compared with bacterial culture in the clinical performance study. Refer to the package insert for complete performance data, limitations, warnings and instructions.
| 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 |
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 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.
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What does the Accutest VALUPAK Strep A Test detect? The test qualitatively detects Streptococcus pyogenes, or Group A β-hemolytic Streptococcus, antigen in throat swab specimens from symptomatic patients. |
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What type of specimen is required? The test is intended for use with direct throat swab specimens collected using the sterile swabs included in the kit. |
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How quickly are results available? Results are read at 5 minutes. Results should not be read before 5 minutes or after 10 minutes. |
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Is the Accutest VALUPAK Strep A Test CLIA Waived? 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. |
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What is included in each kit? 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. |
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How should the test kit be stored? 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. |
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What does a negative result mean? 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. |
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Is this an over-the-counter home test? No. The package insert identifies the Accutest® VALUPAK™ Strep A Test Strip as a prescription, in vitro diagnostic product. |
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