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. 2021 Jun 29;32(2):265–279.

Figure 2.

Figure 2 shows the PPA and NPA for 73 studies reported to FIND.15 Method validation studies showed PPA from 17% to 100% and NPA from 70.4% to 100%. Manufacturer A reported PPA and NPA of 100%; Manufacturer B reported PPA of 97.8% and NPA of 95.6% to FDA based on 60 and 90 known samples. Laboratory results from the same test methods did not mirror each other or the manufacturer. Only 15 studies (20.5%) met the FDA recommendations. FDA defines the acceptance criteria for the performance as 95% agreement at l×-2× Limit of Detection (LoD), and 100% agreement at all other concentrations and for negative specimens.18

PPA and NPA by study