Status Strep Antigen Test
Tests for Strep A
CLIA Waived
Results in 5 minutes
Throat swab
96.2% PPA, 98.7% NPA
Long-dated expiration
Tests for Strep A
CLIA Waived
Results in 5 minutes
Throat swab
96.2% PPA, 98.7% NPA
Long-dated expiration
Tests for Strep A
CLIA Waived
Results in 5 minutes
Throat swab
96.2% PPA, 98.7% NPA
Long-dated expiration
Specifications
CLIA Waived
Test type: Rapid Antigen
Run time: 5 minutes
Collection type: Throat swab
Strep A: 96.2% PPA, 98.7% NPA
CPT Codes:
FDA 510(k)
Manufacturer: Princeton BioMeditach
Storage & Expiration
Store at 2-30°C (35-86°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 (30)
Test strips (30)
Extraction tubes (30)
Bottle Reagent A (1)
Bottle Reagent B (1)
Positive Control (1)
Negative Control (1)
Instructions for use (1)
Manuals & Documents
Intended Use
Direct Group A Streptococcus Antigen Test Strip is a rapid immunochromatographic assay for the qualitative detection of group A streptococcal antigen directly from throat swab specimens. The test is intended for use in the physician’s offices, hospitals, and clinical laboratories as an aid in the clinical diagnosis of group A streptococcal infection.