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The BD Chek™ 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

The BD Chek 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.

Internal Quality Control

Internal procedural controls are included in the test. A red line appearing in the control region (C) is an internal positive procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is an internal negative background control. If the test is working properly, the background in the result area should be white to light pink and not interfere with the ability to read the test result.

External Quality Control

It is recommended that a positive and negative external control be run once per kit, and as deemed necessary by your internal laboratory procedures. External postive and negative controls are supplied in the kit. Alternatively, other group A and non-group A Streptococcus ATCC™ reference strains may be used as external controls. Some commercial controls may contain interfering preservatives; therefore, other commercial controls are not recommended.

Procedure for External Quality Control Testing

1. Add 4 full drops of Reagent A and 4 full drops of Reagent B into an extraction test tube. Tap the bottom of the tube gently to mix the liquid.

2. Add 1 full drop of positive or negative control solution into the tube, holding the bottle upright.

3. Place a clean swab into the tube. Rotate the swab 10 times in the tube. Leave the swab in the tube for 1 min. Then press the swab against the side of the tube and squeeze the bottom of the tube while removing the swab so that most of the liquid stays in the tube. Discard the swab.

4. Continue with Step 4 of Directions For Use.

- Test strips (25)
- Disposable extraction test tubes (25)
- Sterile swabs (25)
- Reagent A (2 M Sodium Nitrite)
- Reagent B (0.4 M Acetic Acid)
- Positive control (Non-viable Strep A; 0.09% NaN₃)
- Negative control (Non-viable Strep C; 0.09% NaN₃)
- Procedure card
- Workstation
- Test tube rack

- For professional in vitro diagnostic use only. Do not use after expiration date.
- Do not eat, drink or smoke in the area where the specimens and kits are handled.
- Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
- Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
- Humidity and temperature can adversely affect results.
- WARNING: Reagent A is harmful if swallowed or absorbed through 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 reagent bottle caps.
- Do not interchange external control solution bottle caps.