Prospective assessment of the false positive rate of the Australian Snake Venom Detection Kit in healthy human samples.

Abstract

The Snake Venom Detection Kit (SVDK; bioCSL Pty Ltd, Australia) distinguishes venom from the five most medically significant snake immunotypes found in Australia. This study assesses the rate of false positives that, by definition, refers to a positive assay finding in a sample from someone who has not been bitten by a venomous snake. Control unbroken skin swabs, simulated bite swabs and urine specimens were collected from 61 healthy adult volunteers [33 males and 28 females] for assessment. In all controls, simulated bite site and urine samples [a total of 183 tests], the positive control well reacted strongly within one minute and no test wells reacted during the ten minute incubation period. However, in two urine tests, the negative control well gave a positive reaction (indicating an uninterpretable test). A 95% confidence interval for the false positive rate, on a per-patient rate, derived from the findings of this study, would extend from 0% to 6% and, on a per-test basis, it would be 0 to 2%. It appears to be a very low incidence (0-6%) of intrinsic true false positives for the SVDK. The clinical impresssion of a high SVDK false positive rate may be mostly related to operator error.