US-based Diagnostics Direct has introduced new clinical laboratory improvement amendments (CLIA)-waived rapid treponemal syphilis test, Syphilis Health Check.
The US Food and Drug Administration has granted waiver under certain laboratory regulations for the test to be used in different health care settings.
Diagnostics Direct sales and marketing vice-president Jeff Tobias said: "Syphilis Health Check is performed by using a sample of whole blood from a finger stick with results available in as little as 12 minutes.
"The test can be performed while the patient is in the office. If a patient tests positive with Syphilis Health Check, the health care provider can immediately obtain a second sample during the same visit for a confirmatory test using traditional nontreponemal testing."
Each Syphilis Health Check test kit includes 20 test devices, 20 fixed volume plastic pipettes and diluent in a dropper bottle containing saline buffer, detergent and sodium azide (NaN3< 0.1%) – 5ml.
Each kit, which also features package insert instructions and a quick reference guide, can be used to carry out 20 tests.
Syphilis Health Check can be used by more healthcare providers, including untrained health care workers, as it received CLIA waiver.