3 ms·

Theranos Herpes Simplex Virus-1 IgG Assay 510(k) [pdf]

2 points by jerryhuang100 11y ago

jerryhuang100 11y ago
(This is an extension of my previous comment [1]) The table 3 in their (only) approved HSV-1 IgG assay 510(k) seems funny: A) No body just check some simple math? In their "Table 3: Design of Precision Study", the Equivocal Panel C, Lot 3 is asterisked with the citation of "sufficient cartridges not available". However if you try to sum up the total valid replicates (27 + 44 + 8 = 79) and just =\= the total of 78. B) Their SD values distributions in table 4 vs numbers of devices (table 3) shows a distinct pattern between small and large numbers of devices used in their precision study. http://imgur.com/HLTKGfM http://imgur.com/HLTKGfM [1] https://news.ycombinator.com/reply?id=10816704 https://news.ycombinator.com/reply?id=10816704