title: 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 0-2%. 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.
authors.affiliation: Emergency Department, Epworth Hospital, 89 Bridge Road, Richmond, Victoria, 3121, Australia; Sunshine Hospital, 176 Furlong Road, St Albans, Victoria, 3021, Australia; Retrieval Services Queensland, Level 2, 410 Queen Street Brisbane QLD 4001, Australia; Australian Venom Research Unit, Department of Pharmacology and Therapeutics, University of Melbourne, Victoria, 3010, Australia. Electronic address: bill.nimo@epworth.org.au.
authors.forename: Vasilios Bill
authors.initials: VB
authors.lastname: Nimorakiotakis
authors.affiliation: Australian Venom Research Unit, Department of Pharmacology and Therapeutics, University of Melbourne, Victoria, 3010, Australia. Electronic address: kdw@unimelb.edu.au.
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Winkel
mesh_terms: D000328:Adult; D000818:Animals; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D008297:Male; D011933:Reagent Kits, Diagnostic; D012910:Snake Venoms / Q000737:chemistry*
chemical_list: D011933:Reagent Kits, Diagnostic; D012910:Snake Venoms
keywords: False positive rate; Immunotypes; Prospective study; Snake venom detection kit; Snakebite; Venom