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. 2016 Jul 19;3(3):18. doi: 10.3390/medicines3030018

Table 13.

Conditions of unintentional reexposure tests in cases of liver injury caused by TCM herbs.

Reexposure Test Result Hepatocellular Injury Cholestatic or Mixed Liver Injury
ALTb ALTr ALPb ALPr

  • Positive

 <5 N ≥2 ALTb <2 N ≥2 ALPb

  • Negative

 <5 N <2 ALTb <2 N <2 ALPb

  • Negative

 ≥5 N ≥2 ALTb ≥2 N ≥2 ALPb

  • Negative

 ≥5 N <2 ALTb ≥2 N <2 ALPb

  • Uninterpretable

 <5 N n.a. <2 N n.a.

  • Uninterpretable

 n.a. ≥2 ALTb n.a. ≥2 ALPb

  • Uninterpretable

 n.a. n.a. n.a. n.a.

Conditions and criteria for an unintentional reexposure test are described in a previous report [51]. Accordingly, required data for the hepatocellular injury are the ALT levels just before reexposure, referred to as baseline ALT or ALTb, and the ALT levels during reexposure, referred to as ALTr. Response to reexposure is positive, if both criteria are met: first, ALTb is below 5 N with N as the upper limit of the normal value, and second, after reexposure, ALT should increase to at least twice the baseline ALT value (ALTr ≥2 ALTb). Other variations are evaluated as negative or uninterpretable results. For the cholestatic or mixed liver injury, corresponding values of ALP are to be used instead of ALT. Abbreviations: ALP, Alkaline phosphatase; ALT, Alanine aminotransferase; HILI, Herb induced liver injury; N, Upper limit of Normal; n.a., not available.