Sensitivity of PCR assays for the determination of hepatitis A virus RNA in plasma pools. A collaborative study

Abstract

Background and objectives: A collaborative study was organised to establish a hepatitis A virus (HAV) RNA standard for genomic amplification assays (GAT).

Materials and methods: A panel of 10 samples consisting of a 10-fold serial dilution of wild-type HAV diluted in HAV-negative cryosupernatant and samples of the diluent were sent to 14 laboratories in duplicate for testing for HAV RNA by the polymerase chain reaction.

Results: Data returned by 12 laboratories indicated that the sensitivities of the assays performed by different laboratories were fairly close: there was a 100-fold difference in sensitivity between the majority of laboratories. Only one laboratory reported false-positive results.

Conclusion: A 10-5 dilution of the virus in cryosupernatant could be an appropriate working reagent for GAT assays for HAV RNA in plasma pools.