As is the case with any other diagnostic procedure, the results obtained by this kit yield data that must be used only as adjunct to other information available to the physician.

· A proper endocervical specimen must be obtained using the swab provided, for best results. Though a patient may be at the onset of the disease, a negative result may be obtained due to low antigen level below the sensitivity of the test. If symptoms persist or intensify, the test should be repeated.

· The InSTIcheck™ test is intended for use only with endocervical specimens collected on appropriate swabs and urine specimens collected in appropriate containers. Performance of the InSTIcheck™ test with other clinical specimens has not been determined.

· Reliable results are dependent on adequate specimen collection. Detection of N. gonorrhoeae is dependent on the number of organisms present in specimens. This may be affected by specimen collection methods and patient factors such as age, history of STD, and presence of symptoms.

· The InSTIcheck™ results are presumptive for all negative results. Negative results can occur from inadequate specimen collection, inappropriate specimen storage or levels of antigen which fall below the limits of detection of the test. Because many individuals infected with N. gonorrhoeae may have lower levels of antigen than detectable by InSTIcheck™ , a negative result cannot be used to exclude infection with N. gonorrhoeae.

· The InSTIcheck™ test results are presumptive for all positive results. Additional evidence should be used to identify N. gonorrhoeae infection.

· As with other non-culture methods, the InSTIcheck™ test should not be used in the investigation of suspected sexual abuse or other medical-legal indications when identification of N. gonorrhoeae could lead to adverse psychosocial impact.

· Because antigen detection methods do not require organism viability, the InSTIcheck™ test may produce a positive result in the absence of living organisms.

· Interpretation of positive results in a low risk or low prevalence population should be made with caution.

· Monoclonal antibodies may not detect all strains of N. gonorrhoeae.