SUMMARY OF VALIDATION STUDIES FROM 26 FORENSIC LABORATORIES IN THE UNITED-STATES AND CANADA ON THE USE OF THE AMPLITYPE(R) PM PCR AMPLIFICATION AND TYPING KIT

A cooperative study was undertaken to collect and summarize the result s of validation studies from forensic laboratories in the United State s and Canada on the use of the AmpliType(R) PM PCR amplification and t yping kit for genetic typing of forensic biological evidence. This rep ort compiles data from 26 laboratories on: 1) reproducibility studies on DNA extracted from various samples, 2) genetic typing of DNA extrac ted from a variety of biological samples on various substrates, 3) the effects of exogenous chemicals, materials, and environmental factors on test results, 4) sensitivity studies to determine the least detecta ble amount of extracted genomic DNA that can be reliably typed, 5) ana lysis of mixtures containing two sources of genomic DNA, 6) cross-hybr idization with DNA extracted from various nonhuman species, and 7) eva luation of assay performance on parallel studies with other genetic ty ping systems on proficiency test panels, mock cases, and adjudicated/n onprobative casework. Equivalent results were obtained by each laborat ory that supplied data, demonstrating the reliability and consistency of the test. Overall, it can be concluded from this study that the Amp liType PM PCR amplification and typing kit meets the guidelines of the Technical Working Group on DNA Analysis Methods (TWGDAM) and there is general scientific acceptability of this kit for forensic DNA testing .