An Update: Clarification on BioAgilytix AMH Assay Validation Study Results

It has come to our attention that a research study titled Evaluation of at-home serum anti-Mullerian hormone testing: a head-to-head comparison study, published on September 1, 2022, by BioMed Central Ltd. contained certain data and conclusions related to our Tap II collection device and Advance DX’s “ADx 100” card. In the research study, Boston-based laboratory BioAgilytix validated an AMH assay for Turtle Health, wherein venipuncture results for Advance DX’s “ADx 100” card were compared to Tap II collection device results. We have been informed by Advance DX that BioAgilytix has issued the following statement regarding the research study:

BioAgilytix validated an AMH assay for Turtle Health, wherein venipuncture results were compared to Tap II collection device results. Appendix A of the related validation report includes ADx concordance to venipuncture for AMH. Subsequently, BioMed Central Ltd. improperly used a simulated internal control, rather than the ADx card manufacturer’s suggested actual measurement of the internal control as a normalization factor in each sample tested. As such, any discordance noted in the study may be due to BioMed Central Ltd.’s failure to follow the manufacturer’s instructions for the ADx card, and not due to any fault of the ADx card itself.

Further, the research study discloses that BioMed Central Ltd. used a simulated internal control, rather than the ADx card manufacturer’s suggested actual measurement of the internal control as a normalization factor in each sample tested. The research study further discloses that any discordance noted in the study may be due to BioMed Central Ltd.’s decision to use a different control than that recommended by the manufacturer’s instructions for the ADx card, and not due to any fault of the ADx card itself.