Immunoassay for the detection of group A streptococcal antigen

Status™ Strep A Test

(Box of 30)

Immunoassay for the detection of group A streptococcal antigen

Status™ Strep A Test

CLIA Waived with results in 5-10 minutes, the Status™ Strep A Test (Strip) rapidly detects the group A streptococcal antigen directly from throat swab specimens.

General Details

      • CLIA WAIVED
      • Easy extraction for fast reaction times
      • Sensitivity of 96.2% and specificity of 98.7%
      • Results in 5-10 minutes
      • External negative and positive controls included

Box components

      • Test Kit (30)

      • Extraction Reagent A

      • Extraction Reagent B
      • Positive and Negative Control
      • Rayon Throat Swabs

Status™ Strep A Test

Manuals + Instructions

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.

Clinical Details
      • Status Strep A 18/48 Culture Results
        • Sensitivity (127/132): 96.2%
        • Specificity (368/373): 98.7%
        • Overall Accuracy (495/505) 98.0%
Storage

Status Strep A test strip should be stored at 2-30°C (35-86°F) in its original sealed pouch, out of direct sunlight. Do not freeze. Kit contents are stable until the expiration date printed on the outer box.

CONTACT

Direct Connect

11 + 8 =

Phone

(310) 957-9891