- Condition: Factory New
- Country of Origin: USA
- Warranty: Not Available
- Weight: 1.53 lb
- Patented single use reagent capsules
- CLIA waived
- Positive, accurate results are ready in five minutes
- Physician’s licensing required. This is NOT an at-home test and should only be completed in a lab facility
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Learn more:
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Purchasing Restriction: Medical license or prescription required
- MFR: LifeSign Ships from Manufacturer
- MPN: 34125
- Phone: (800) 526-2125
Frequently asked questions
How fast are the Strep A Flip test results?
The LifeSign Status Strep A Flip test delivers exceptionally rapid results, providing positive readings in just five minutes. This quick turnaround time is designed to aid prompt clinical decisions.
This speed is combined with high diagnostic accuracy, which is enhanced by the patented single-use reagent capsule system that simplifies the procedure:
| Metric | Value |
|---|---|
| Sensitivity | 96% |
| Specificity | 99% |
Does the Strep A Flip test have high accuracy?
Yes, the LifeSign Status Strep A Flip test is designed for high performance and accuracy in detecting Group A streptococcal antigens from throat swab specimens. This rapid diagnostic test provides positive results in just five minutes.
Its enhanced accuracy is partly due to the patented single-use reagent capsules, which streamline the procedure by eliminating the manual counting of reagent drops, a common source of error.
The key performance specifications are:
- Sensitivity: 96%
- Specificity: 99%
Is the Strep A test CLIA waived?
Yes, the LifeSign Status Strep A Flip test is CLIA waived. This designation simplifies regulatory requirements, making it suitable for utilization in professional laboratory environments.
It is important to note that this product requires a physician’s license for use and must only be completed in a lab facility; it is explicitly not an at-home test.
What components are included in the Strep A Flip kit?
The LifeSign Status Strep A Flip kit contains 25 complete tests and includes all necessary components for accurate, rapid Strep A antigen detection from throat swab specimens.The kit includes the following components:
- 25 Test Devices
- 25 Swabs (for specimen collection)
- 25 Single-Use Reagent Capsules: These patented capsules simplify the procedure by eliminating the need to count reagent drops, which enhances accuracy.
- Positive External Control
- Negative External Control
Is this Strep A test strictly for professional use?
Yes, the LifeSign Status Strep A Flip is strictly for professional use and must be performed in a clinical or laboratory setting. It is not an at-home test.
Key requirements for its use include:
- A physician’s license is required to administer this professional diagnostic test.
- The test is CLIA waived, simplifying regulatory requirements for its use in authorized lab settings.
- It uses a patented single-use reagent capsule system, which reduces procedural steps and enhances accuracy.
Does the test include necessary controls for quality assurance?
Yes, the LifeSign Status Strep A Flip kit is a complete solution, and it includes both positive and negative external controls to ensure quality assurance and reliable test performance.
Does the reagent capsule design improve testing consistency?
Yes, by utilizing patented single-use reagent capsules, the system effectively eliminates the need for manual reagent drop counting. This design significantly reduces the potential for procedural error and helps ensure more reliable and consistent results for every test performed.
What documentation is required to purchase these test kits?
Because these are professional-grade diagnostic tools intended for laboratory use, physician’s licensing is required for purchase. Please ensure your facility meets these regulatory requirements before placing an order, as this product is strictly restricted to use by licensed medical professionals.
Does this Strep A test simplify reagent handling?
Yes, the LifeSign Status Strep A Flip is designed for simplified reagent handling and enhanced procedural accuracy.
It utilizes patented single-use reagent capsules, which eliminates the need to manually count and dispense reagent drops. This crucial design feature streamlines the rapid diagnostic process by reducing procedural steps and minimizing the potential for user error.
Is the Strep A Flip test performed using throat swab specimens?
Yes, the LifeSign Status Strep A Flip test is specifically designed for the detection of Group A Streptococcal (GAS) antigens directly from throat swab specimens.
This CLIA-waived diagnostic tool offers high-performance results quickly:
- Target: Group A Streptococcal antigens.
- Specimen Type: Throat swab.
- Speed: Positive results are ready in just five minutes.
- Accuracy: The test features high performance with 96% Sensitivity and 99% Specificity.