FDA-RFQ-1238058 COVID Testing Additional QA (no. 4).pdf

FDA-RFQ-1238058

Additional Q&A (#4)

ADDITIONAL QUESTIONS AND ANSWERS

The following are the questions submitted prior to receipt of quotes/proposals and their corresponding answers.

Question 1: Does the home collection method have to have a separate EUA from the test method? (Our collection method is saliva (spit) in a sterile container so EUA is typically required.)

Response: The SOW states “The contractor shall provide:

- Home collection kits that are authorized for use with a nucleic acid amplification test (NAAT) (e.g., real time polymerase chain reaction (RT-PCR)) that has been granted an Emergency Use Authorization (EUA) from the FDA for screening of asymptomatic individuals.”

Question 2: Does the employee have to have access to their results via web portal or can a central person at each FDA office access the results.?

Response: The SOW states “The contractor shall provide:

- Results available via an electronic, interactive portal to FDA and the employee who was tested within 48 hours of receipt at the contractor or its testing laboratory.” The FDA provides further clarification that yes, each employee should have access to their results via a web portal. Additionally, the ordering provider should also have access to each employee’s results.

Question 3: Is RT-PCR via saliva an acceptable methodology for the test?

Response: See Question/Response #16 on the initial QA response document.

(End of Q&A)