Biotech Values

[DewDiligence]

Re: HCV assays and cut-offs

Actually, the distinction between a 10 IU/ml and a 20 IU/ml cutoff is almost meaningless from a practical standpoint. 10-20 IU/ml is near the lower limit of detection of the TaqMan assay and is below the limit of quantitation of the assay. (In other words, at those levels, you can tell that the assay detected something, but you can’t tell how much.)

The important practical distinction is between the TaqMan assay and older Amplicor and Versant assays, which have a much higher limit of quantitation of about 600 IU/ml.