CLIA #

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A reliable and accurate solution for the qualitative detection of Streptococcus pyogenes antigen in throat swab specimens to aid in the diagnosis of Strep A bacterial infection.

A rapid antigen point-of-care Strep A test, designed to provide accurate results within minutes. This innovative test aids healthcare providers in improving patient outcomes with timely and precise care.

• For in vitro diagnostic use.
• For prescription use only.

• Quick and Accurate: Providing results in just 5 minutes, this highly sensitive test ensures reliable detection of Streptococcus pyogenes
• Convenient for Healthcare Providers: Simple procedure with minimal training required for staff, portable and easy to use in various clinical settings
• Improved Patient Care: A faster diagnosis and more timely treatment streamlines the diagnostic process, making patient management more efficient and effective

POC (CLIA-WAIVED) Strep A Antigen Test Kit

Results in 5 minutes

25 tests per box

Minimum Order 4 boxes (100 tests)

Contents

• 25 Test strips
• 25 Sterile swabs
• 25 Disposable extraction tubes
• 1 Reagent A
• 1 Reagent B
• 1 Positive Control
• 1 Negative Control
• 1 Instructions for Use
• FDA 510(k) Cleared/CLIA waived
• For in vitro diagnostic use

Specimen Type

Throat Swab

Format

Strip

Performance Specifications

Sensitivity 97.1%, Specificity 99.4%

The Rapid Strep A Antigen Test is a rapid chromatographic immunoassay for the qualitative detection of Streptococcus pyogenes antigen from throat swab specimens of symptomatic patients to aid in the diagnosis of Group A Streptococcus bacterial infection. All negative tests should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.

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INDICAID Rapid Strep A IFU