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The Directigen™ EZ Group A Strep Test is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of group A streptococcal infection.

Streptococcus pyogenes is a non-motile gram-positive coccus, which contains the Lancefield group A antigen that can cause serious infections such as pharyngitis, respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis.¹ Left untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess.² Traditional identification procedures for group A streptococcal infection involve the isolation and identification of viable organisms using techniques that require 24 to 48 h or longer.³

Rapid diagnosis and early antibiotic therapy of group A streptococcal infection appear to be the best means of preventing medical complications and reducing the spread of the disease.⁴

The Directigen EZ Group A Strep Test is a rapid test to qualitatively detect the presence of Strep A antigen in throat swab specimens, providing results within 5 min. The test utilizes antibodies specific for whole cell Lancefield group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen.

Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to pertinent CLSI (formerly NCCLS) guidance and CLIA regulations for appropriate Quality Control practices.

Test Devices (25)
Disposable Extraction Test Tubes (25)
Extraction Tube Tips (25)
Sterile Swabs (25)
Reagent A (10 mL), 2 M Sodium Nitrite
Reagent B (10 mL), 0.4 M Acetic Acid
Positive Control (1 mL), Non-viable Strep A; 0.09% NaN₃
Negative Control (1 mL), Non-viable Strep C; 0.09% NaN₃
Workstation
Test Tube Rack
Procedure Card

For professional in vitro diagnostic use.

Do not use after expiration date.

Do not eat, drink or smoke in the area where the specimens and kits are handled.

Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard Precautions" ^5-8 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids.

Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

Humidity and temperature can adversely affect results; therefore, test the device at room temperature (15-30°C) as soon as it is removed from the pouch.

WARNING: Reagent A is harmful if swallowed or absorbed through the skin. May cause eye irritation.

CAUTION: Reagent B may cause skin, eye and respiratory tract irritation. Reagent B contains an acidic solution. If the solution contacts the skin or eye, flush with large volumes of water.

The positive and negative controls contain sodium azide (NaN₃) as a preservative.

Do not interchange kit reagents.

Do not interchange reagent bottle caps.

Do not interchange external control solution bottle caps.