A collaborative study on DNA quantitation in biological products

In 1988, a collaborative study was set up to examine the sensitivity and reproducibility of assays for the detection of DNA in biologicals derived from continuous cell lines. Fifteen laboratories analyzed 12 samples containing different amounts of DNA and protein. When no or very little DNA was present in the test samples, false positives or overestimation was common. In contrast, when higher levels of DNA were present underestimation was the norm. The study also revealed a high degree of variability between laboratories.