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Hi all,
I am a recent graduate and need help with verification of APTIMA gonorrhea and chlamydia test in our small lab. Its an FDA teest so from my reading all you really need is precision and accuracy test. For accuracy: do you have to have minimum 20 specimens. Do you have to run it over 5 days minimum.
FOr precision: Can you get away running any positive and negative sample or does it have to be a (low positive i.e. 1xLoD) and high negative.
Is there minimum of days to do interday precision.
Is there minimum of runs for Intra-day precision.
I would really appreciate your help
I am a recent graduate and need help with verification of APTIMA gonorrhea and chlamydia test in our small lab. Its an FDA teest so from my reading all you really need is precision and accuracy test. For accuracy: do you have to have minimum 20 specimens. Do you have to run it over 5 days minimum.
FOr precision: Can you get away running any positive and negative sample or does it have to be a (low positive i.e. 1xLoD) and high negative.
Is there minimum of days to do interday precision.
Is there minimum of runs for Intra-day precision.
I would really appreciate your help
