Status™ Strep A Strip Test
Status™ Strep A Strip Test
Status™ Strep A Strip Test

Status™ Strep A Strip Test

SKU: KS/34130
In Stock

Strep

Rapid Results Within 5-10 Minutes
Strong Clinical Performance- Provides 96.2% sensitivty and 98.7% specificity
Simple Dip-and-Read Testing
CLIA license Required to purchase this product
$50.10
$1.67 USD per test (30 test per box)

Volume Discounts

10-20 boxes $45.00 per box ($1.50 per test)
21-39 boxes $43.50 per box ($1.45 per test)
40-49 boxes $42.60 per box ($1.42 per test)
50+ boxes Request Bulk Discount
Quantity:
Request Bulk Pricing Download Product Brochure Download Product Insert
  1. Prepare the extraction solution
    Add 4 drops of Reagent A and 4 drops of Reagent B to the extraction tube. Gently mix the tube. The solution should turn pink.
  2. Add the throat swab
    Immediately place the collected throat swab into the extraction tube.
  3. Extract the specimen
    Rotate the swab vigorously in the solution, then allow it to stand for 1–2 minutes.
  4. Remove the swab
    Press the swab firmly against the side of the tube to squeeze out as much liquid as possible. Remove and discard the swab.
  5. Insert the test strip
    Remove the Status® Strep A test strip from the sealed pouch and place it into the tube containing the extracted specimen.
  6. Read the result
    Read the test at 5 minutes. Do not read the result after 10 minutes.

Result Interpretation

  • Positive: Two reddish-purple lines appear—one at the Control line and one at the Test line. Even a faint test line should be considered positive.
  • Negative: Only the Control line appears.
  • Invalid: No Control line appears. Repeat the test with a new strip and a new throat swab specimen.

Important: For professional use with throat swab specimens. Follow the complete manufacturer’s Instructions for Use and your facility’s testing procedures.

The Status® Strep A Test is a rapid, CLIA Waived immunochromatographic assay designed for the qualitative detection of Group A Streptococcal (GAS) antigen directly from throat swab specimens. Delivering accurate results in 5–10 minutes, this easy-to-use dip-and-read test helps healthcare professionals quickly diagnose Streptococcal pharyngitis (Strep A) and make timely treatment decisions.

Designed for physician offices, urgent care centers, walk-in clinics, and other point-of-care settings, the Status® Strep A Test combines high clinical performance with a simple testing procedure. With 96.2% sensitivity and 98.7% specificity, the test provides dependable results while minimizing unnecessary antibiotic use through accurate identification of Group A Streptococcus.

Key Features

  • Rapid results in 5–10 minutes
  • Detects Group A Streptococcal (GAS) antigen
  • CLIA Waived for point-of-care testing
  • High clinical performance with 96.2% sensitivity and 98.7% specificity
  • Simple dip-and-read immunochromatographic assay
  • Uses easy-to-collect throat swab specimens
  • Quality control materials included
  • 25 tests per kit

Intended Use

The Status® Strep A Test is intended for the qualitative detection of Group A Streptococcal antigen from throat swab specimens collected from patients with signs and symptoms consistent with streptococcal pharyngitis. The test is intended to aid healthcare professionals in the diagnosis of Group A Streptococcal infections and should be interpreted alongside clinical findings and patient history. Negative results should be confirmed by bacterial culture when clinically indicated.

Ideal For

  • Physician offices
  • Urgent care clinics
  • Family practice
  • Pediatric clinics
  • Student health centers
  • Community health clinics
  • Point-of-care laboratories
  • Streptococcal

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