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? 

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Christy, After reading your post, I called Diagnostics Direct and spoke with co-founder Jeff Tobias. He was responsive to the potential need to change this wording as he said this recommendation was not the company's intent to create an onerous task. I sent your post to him, next is his reply:
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. 
Thank you for bringing this to our attention. 
Jeff Tobias
Chief Operating Officer
O) 866-358-9282 ext. 102
C) 609-647-6464
F) 877-854-4187

Our Public Health Dept does utilize this product out in the field with only whole blood fingerstick collection. The Public Health nurses are often outside. Even though training includes the acceptable operating temperature, they attempted to run the test in cold circumstances less than 15'C/59'F. The cartridge does not work as intended in cold temperatures. We discussed the need to follow the 15-30'C recommendation. 

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Christy Covington
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