As with other diagnostic procedures, the results obtained with this kit should be used as an adjunct to clinical observations and information available to the physician. The InSTIcheck™ Chlamydia test is a qualitative method intended for use in determining the presence of Chlamydia antigen in cervical swab specimens or urine only.

• 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, negative results may also occur if the specimen contains sufficiently low numbers of microorganisms to fall below the level of sensitivity of the test.

• If a negative test result is obtained and clinical symptoms persist, the initial result should be con?rmed by repeating the test with another specimen.

• Detection of Chlamydia is dependent on the number of organisms present in the specimen. This may be affected by specimen collection methods and patient factors such as age, history of STD, presence of symptoms, etc.

• The InSTIcheckTM Chlamydia test will not speci?cally differentiate C. trachomatis, C. pneumoniae, or C. psittaci.

• Detection of Chlamydia is dependent on the number of organisms (elementary and/or reticulate bodies) present in specimens. This may be affected by specimen collection methods and patient factors such as age, history of STD, and presence of symptoms.