Indicaid Strep Antigen Test
Tests for Strep A
CLIA Waived
Results in 5 minutes
Throat swab
97.1% PPA, 99.4% NPA
Long-dated expiration
Tests for Strep A
CLIA Waived
Results in 5 minutes
Throat swab
97.1% PPA, 99.4% NPA
Long-dated expiration
Tests for Strep A
CLIA Waived
Results in 5 minutes
Throat swab
97.1% PPA, 99.4% NPA
Long-dated expiration
Specifications
CLIA Waived
Test type: Rapid Antigen
Run time: 5 minutes
Collection type: Throat swab
Strep A: 97.1% PPA, 99.4% NPA
CPT Codes: 87880QW
FDA 510(k)
Manufacturer: Phase Scientific
Storage & Expiration
Store at 4-30°C (39-86°F)
Do not freeze any contents of the kit.
Reagents and materials are stable until expiration date printed on outer packaging.
Test device must remain in the sealed pouch until use.
Box Components
Throat swabs (25)
Test strips (25)
Extraction tubes (25)
Bottle Reagent A (1)
Bottle Reagent B (1)
Positive Control (1)
Negative Control (1)
Instructions for use (1)
Manuals & Documents
Intended Use
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.