SV40 Virus

Test code: S0016 - Qualitative detection of SV40 Virus by polymerase chain reaction

SV40 is a double-stranded DNA polyomavirus that shares a high degree of sequence homology with the known human polyomaviruses, JC virus and BK virus. Widespread exposure of humans to this virus occurred during the period of poliovirus vaccine contamination between 1955 and 1962. This exposure is of concern because SV40 induces malignancies in laboratory animals, notably brain tumors. Following the discovery of SV40 in 1960, poliovirus vaccines have been required to be free of SV40.

The fact that continuous cell lines of animal origin are routinely used to manufacture recombinant proteins with pharmaceutical applications raises concern about the safety of these products. Although virus isolation can be used to diagnose SV40 virus infection, it requires a long period of time to obtain results. Furthermore, viral culture is neither sensitive nor specific, and increases the potential risk of laboratory workers contacting this virus. Antigenic detection of SV40 infection is also not very reliable, sensitive or specific. False negative and false positive results occur frequently.

SV40 detection by PCR is the most rapid, sensitive and specific method for the diagnosis of this infection. The method can also differentiate the virus from other closely related polyomaviruses.

Utilities:

• Confirm the disease causing agent
• Ensure that animal colonies are free of SV40
• Early prevention of spread of this virus among a colony
• Minimize personnel exposure to this virus
• Safety monitoring of biological products and vaccines that derive from primates

Specimen requirement: 1 ml whole blood in EDTA (purple top) or ACD (yellow top) tube, or a T25 flask of cell culture, or 1 ml urine, shipped overnight at room temperature.

For specimen types other than those listed here, please call to confirm specimen acceptability and shipping instructions.

For all specimen types, if there will be a delay in shipping, or during very warm weather, refrigerate specimens until shipped and ship with a cold pack unless more stringent shipping requirements are specified. Frozen specimens should be shipped so as to remain frozen in transit. See shipping instructions for more information.

Turnaround time: 2 business days

Methodologies: Qualitative PCR

Normal range: Nondetected