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Description

The LifeSign Status Strep A Plus (#34250 / 50 Tests per canister) includes external negative and positive controls.

Note: Physician’s licensing required. This is NOT an at-home test and should only be completed in a lab facility.

A rapid immunochromatographic assay, the LifeSign Status Strep A Plus is designed for the detection of group A streptococcal antigens directly from throat swab specimens. CLIA waived, the Strep A Plus is extremely accurate and presents results in as easy to read format in as little as 5-10 minutes.

Features

LifeSign Status Strep A Plus Features

  • CLIA waived.
  • Easy to follow, simple "dip and read" procedure.
  • Results are ready in as little as 5-10 minutes.
  • Includes external negative and positive controls.
  • New eco-friendly and easy to use packaging.

Specifications

LifeSign Status Strep A Plus Specifications

  • # of Tests: 50.
  • Sensitivity: 96.2%.
  • Specificity: 98.7%.

Frequently asked questions

Does the Strep A Plus deliver rapid results?

Yes, the LifeSign Status Strep A Plus test is designed for rapid identification, delivering results in as little as 5 to 10 minutes. This quick turnaround enables healthcare professionals to make faster clinical decisions.

What is the accuracy of the Strep A Plus test?

The LifeSign Status Strep A Plus test demonstrates high analytical performance, offering rapid and reliable results.The key accuracy metrics are: * Sensitivity: 96.2% * Specificity: 98.7%

Is this high-performance test CLIA waived?

Yes, the LifeSign Status Strep A Plus assay is officially CLIA waived.

This designation means the test is classified for low complexity testing under the Clinical Laboratory Improvement Amendments. This status allows the assay to be utilized efficiently in a variety of waived testing environments, such as physician’s offices and urgent care facilities, ensuring compliance and ease of implementation for rapid screening.

Does the Strep A Plus kit include reliable controls?

Yes, the LifeSign Status Strep A Plus kit is supplied as a complete diagnostic package, including essential components for quality assurance. The kit contains both external negative and positive controls to ensure the validity and reliability of the test results.

What are the test's sensitivity and specificity?

The LifeSign Status Strep A Plus offers high diagnostic performance for the qualitative detection of Group A streptococcal antigens. The key accuracy metrics for this rapid immunochromatographic assay are:

  • Sensitivity: 96.2%
  • Specificity: 98.7%

These strong metrics demonstrate high accuracy, supporting reliable results when screening throat swab specimens.

Is the Strep A Plus test for at-home use?

No, the LifeSign Status Strep A Plus test is not intended for at-home use. It must be completed in a lab facility and requires a physician’s licensing.

Does the Strep A Plus kit feature eco-friendly packaging?

Yes, the LifeSign Status Strep A Plus kit features new eco-friendly and easy-to-use packaging.

What specimen type is required for this test?

The LifeSign Status Strep A Plus test is designed for the qualitative detection of Group A Streptococcal antigens directly from throat swab specimens. This rapid immunochromatographic assay delivers results quickly, typically within 5 to 10 minutes.

How many rapid Strep A tests are included?

Each LifeSign Status Strep A Plus kit contains 50 tests per canister, providing a comprehensive supply for rapid detection of group A streptococcal antigens.

Does the Strep A Plus use a simple procedure?

Yes, the Status Strep A Plus is designed for operational simplicity in clinical environments. This rapid immunochromatographic assay utilizes an easy-to-follow, simple “dip and read” procedure.

This straightforward method ensures results are typically delivered in as little as 5 to 10 minutes, facilitating rapid diagnostic decisions.