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Polymerase chain reaction (PCR) is an in vitro method that exponentially amplifies a targeted fragment of deoxyribonucleic acid (DNA). If the target of interest is a DNA virus or plasmid, DNA is extracted from the test article, and sequence-specific primers and a polymerase are used to amplify the DNA fragment of interest. If the target of interest is an RNA virus, RNA is extracted from the test article and incubated in the presence of the enzyme reverse transcriptase (RT). The RNA is transcribed into a complementary DNA (cDNA) by the RT enzyme, which is further amplified by PCR (RT-PCR). Our PCR assays use a high-resolution agarose gel with ethidium bromide to resolve the PCR amplification product. PCR assays are commonly used to test cell banks; however, many types of samples can be tested and can be used for test articles of limited volume. The fast turnaround time of these assays is another attractive feature.

Each PCR study has multiple assay controls to confirm the optimal performance of the assay and to confirm the absence of reagent contamination and PCR inhibitors, thereby ensuring that reproducibility, sensitivity, and accuracy are achieved.

BioReliance offers PCR assays for a variety of applications, such as the following:

• Detection or quantification of DNA or RNA viruses in cell banks and bulk harvest material
• Complementary assays to our viral clearance infectivity studies
• Alternative to electron microscopy particle counting in unprocessed bulk or other types of material
• Detection of residual host cell DNA in bulk product