Internal Procedural Controls: A procedural control is built into each dipstick. The appearance of a line in the control region assures the correct test procedure was followed, indicating sufficient volume of fluid was used and that capillary flow occurred. At the end of 5 min, formation of a control line verifies the sample has flowed through the test region and the test is complete. The test is invalid if the control line does not appear.

Good laboratory practice recommends the use of control materials. Users should follow the appropriate federal, state and local guidelines concerning the running of external quality controls.

Kit Quality Controls: These controls are bacteria-based and tested like a patient sample. When testing controls, add 3 drops of extraction Reagent 1 and 3 drops of extraction Reagent 2 to the Extraction tube. Then add 1 drop of Positive or Negative Control to the Extraction tube. Place a sterile swab into the tube and swirl. Continue with Test Procedure Step 5.

A positive result is indicated by two lines, one in the control region and one in the test region. A negative result is indicated by only one line in the control region. Observe results at 5 min and do not interpret after 10 min.

If the controls do not perform as expected, do not interpret the test results. Repeat the test or contact Technical Services.

The positive and negative external controls should be tested for each new lot, new shipment or new operator.

BD Chek Strep A Kit

Dipsticks (25), each individually packed dipstick containing a membrane strip that has been pre-coated with rabbit anti-Strep A and a colored rabbit anti-Strep A polyclonal antibody-colloidal gold conjugate pad.

Reagent 1 (12 mL), Extraction, 5M sodium nitrite.

Reagent 2 (12 mL), Extraction, 0.03M citric acid.

Control + (2 mL), Positive Control, heat-killed group A Streptococcus in solution (1 x 10⁸ organisms/mL) with 0.1 % sodium azide (preservative).

Control - (2 mL), Negative Control, heat-killed group B Streptococcus in solution (1 x 10⁸ organisms/mL) with 0.1 % sodium azide (preservative).

Extraction tubes (25), in zip bag.

Polyester Swabs (25), sterile, individually packed.

Plastic Workstation (1); reusable, for 5 tests at a time.

Instructions and Procedure Card.

For in vitro Diagnostic Use.

For professional and laboratory use only.

1. Do not use the kit if the Control + and Control - do not yield appropriate results.

2. 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.

3. Do not use kit components beyond the expiration date.

4. Do not mix reagents from different kit lot numbers or mix reagent bottle caps. Do not reuse dipstick.

5. The extraction Reagents 1 and 2 are slightly caustic. Avoid contact with eyes or mucous membranes. In the event of accidental contact, wash area thoroughly with water.

6. Positive and Negative Controls contain sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides. When disposing of these solutions, always flush with copious amounts of water to prevent azide build-up.

7. Standard guidelines for handling infectious agents and chemical reagents should be observed throughout all procedures. All contaminated waste such as swabs, Strep A test dipsticks and extracts should be properly disposed.

8. Package insert instructions must be followed to obtain accurate results.

9. The pouch containing the dipstick should be sealed. Discard the test device if the package is ripped or torn.