Controls should be tested each day the GonoGen II test is performed for patients, to ensure the system is functioning properly. The controls may be performed along with the test specimen.

The Control + (Positive) and Control – (Negative) should be performed each day a test is used.

1. Label a small test tube (12 × 75 mm) with Control +.

2. Label a small test tube (12 × 75 mm) with Control –.

3. Dispense 500 µL of Reagent 1 into each of these tubes.

4. Add 1 drop of well-mixed Control + into the tube marked Control +.

5. Add 1 drop of well-mixed Control – into the tube marked Control –.

6. Mix well by shaking vigorously.

7. Add 1 drop of Reagent 2 into the Control + tube, and 1 drop into the Control – tube.

8. Mix and wait at least 5 min.

9. Add 2 drops of the Control + into a well in the test tray.

10. Add 2 drops of the Control – into a separate well in the test tray.

11. Using a clean transfer pipet, add 1 drop of Reagent 1 to each completed test well.

Reagent 1 GonoGen II solubilizing buffer. Organisms from a suspected isolate of N. gonorrhoeae are suspended in this buffer prior to addition of GonoGen II reagent. Contains 0.09% sodium azide (preservative).

Reagent 2 GonoGen II murine monoclonal antibodies to the Protein I antigens of N. gonorrhoeae that have been absorbed to metal sol particles. Contains 0.05% sodium azide (preservative).

Control + GonoGen II heat-killed N. gonorrhoeae. When mixed with the GonoGen II reagent and applied to a well on the reaction device, a positive reaction is visible as a pink to red dot. Contains 0.05% sodium azide and 0.01% gentamicin sulfate (preservatives).

Control – GonoGen II heat-killed Neisseria species other than N. gonorrhoeae. When mixed with the GonoGen II reagent and applied to a well on the test tray, no reaction will be visible. Contains 0.05% sodium azide and 0.01% gentamicin sulfate (preservatives).

Test Tray: Consists of wells with a special matrix and absorbent material. When the GonoGen II sample reactant is added, a positive (pink to red dot) or negative (white to pale pink dot) result is observed on the matrix.

For in vitro Diagnostic Use.

This product contains dry natural rubber.

Reagents: Do not use beyond the expiration date. Upon removal from the refrigerator, allow reagents to warm to room temperature before use. Do NOT mix reagents from different kit lot numbers. Prior to use reagents should be vigorously shaken or vortexed for 10 s prior to use.

Warning: Reagents contain sodium azide which may react with lead and copper plumbing to form highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide buildup.

Controls: Do not use the kit if positive and negative controls do not yield appropriate results.

To assure proper drop delivery, the dropper rod assembly, transfer pipet and reagent bottles should be held vertically, dispensing free-falling drops.