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Description

LifeSign Respiratory Test Kit Status Strep A Test 5 Tests CLIA Waived

Frequently asked questions

Does this test provide rapid diagnostic results?

Yes, this kit is designed for efficiency, delivering accurate test results in just 5 minutes. This speed helps facilitate quick clinical decision-making for healthcare providers.

Is this test suitable for point-of-care settings?

Absolutely. The Status Strep A Flip is CLIA-waived, making it ideal for use in various professional environments, including:

  • Physician offices
  • Urgent care centers
  • Pediatric clinics
What technology does this diagnostic kit use?

The test utilizes reliable solid-phase immunochromatographic assay technology. This method employs a straightforward chemical extraction process to ensure consistent, high-quality results from throat swab samples.

Are all necessary components included in the kit?

Yes, the kit is a complete diagnostic package. It includes:

  • 5 Test Devices
  • 1 mL Positive Control
  • 1 mL Negative Control
  • Throat Swabs
  • Instructions for Use
  • Procedure Card
Is this kit compliant with American manufacturing standards?

Yes, this product is proudly manufactured in the United States and is both Buy American Act (BAA) compliant and Trade Agreement Act (TAA) compliant.

How simple is the testing procedure?

The procedure is designed for ease of use in clinical settings. It requires a simple throat swab for collection, followed by a straightforward chemical extraction process that is visually read to provide results quickly.

What type of sample is required for testing?

The Status Strep A Flip requires only a standard throat swab sample to perform the assay, making the collection process efficient for both the clinician and the patient.

Does the kit include quality control materials?

Yes, to ensure accurate and reliable testing, the kit includes both positive and negative liquid controls (1 mL each) for validating test performance.

Is this test intended for professional use?

Yes, the Status Strep A Flip is engineered specifically for professional use in clinical environments to assist in respiratory infection screening protocols.

How many tests are provided in one kit?

Each kit contains all the necessary components to perform five individual assays.