Description
The Status™ Strep A Strip Test is a rapid, accurate, and easy-to-use in vitro diagnostic test for the qualitative detection of Group A Streptococcal antigen from throat swab specimens. Designed for use in physician offices, urgent care centers, clinics, and pharmacies, this CLIA-waived rapid test delivers results in as little as 5 minutes, helping providers initiate treatment quickly.
This test is a critical tool in diagnosing strep throat, reducing unnecessary antibiotic use and ensuring proper care for patients.
Key Features:
-
✅ Rapid Results in 5 Minutes
-
✅ High Sensitivity & Specificity
-
✅ CLIA Required (for professional healthcare use)
-
✅ Room Temperature Storage – No refrigeration needed
-
✅ Easy-to-Read Results – Clear color line indicators
-
✅ 25 Individually Wrapped Tests per Box
Package Contents:
-
25 Test Devices (individually pouched)
-
Extraction Reagents and Tubes
-
Sterile Throat Swabs
-
Positive & Negative Controls
-
Instructions for Use (IFU)
Who Should Use This Product?
-
Primary care physicians
-
Pediatricians
-
Urgent care clinics
-
Walk-in health centers
-
Mobile testing units
-
Pharmacies offering clinical services
How It Works:
-
Collect throat swab sample from the tonsillar area.
-
Mix swab with provided reagents in extraction tube.
-
Insert test strip and wait for results.
-
Interpret visually within 5–10 minutes.
Positive Result: Two color lines (Control and Test)
Negative Result: One color line (Control only)
Compliance and Certification:
-
FDA Cleared
-
CLIA Complexity: Waived
-
Intended Use: Professional healthcare environments only
Why Choose Status™ Strep A Test?
Accurate diagnosis of Group A Strep allows for timely treatment and helps prevent complications like rheumatic fever. The Status™ test offers speed, accuracy, and convenience, making it an essential tool for point-of-care diagnostics.
Order now to ensure your clinic or healthcare setting is prepared with fast, accurate, and trusted strep testing.
