Syphilis Health Check Diagnostics Direct
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We recently got a request for syphilis testing in a clinic setting. The only waived kit we were able to find on the market was the Syphilis Health Check Diagnostics Direct test. Is anyone using this kit? We would love to hear how this testing works and if there were any issues encountered.
We did notice when researching this that there is a requirement that external quality control be performed with each new lot, new shipment, monthly, and with each new operator (an individual who has not run the test for at least two weeks). Does anyone have suggestions on how to manage the requirement for each new operator an individual who has not run the test for at least two weeks?
We did notice when researching this that there is a requirement that external quality control be performed with each new lot, new shipment, monthly, and with each new operator (an individual who has not run the test for at least two weeks). Does anyone have suggestions on how to manage the requirement for each new operator an individual who has not run the test for at least two weeks?
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I spoke with our CEO and Chief Technical Officer, and these are suggested options and not all required. We are going to change the wording in the IFU on the next print run to clear up the confusion.