primate assay data sheet
SV40 virus (aka simian vacuolating virus 40)
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:
-
Help confirm the disease causing agent
-
Help 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: 0.2 ml whole blood in EDTA (purple top) tube, or 0.2 ml cell culture, or 0.2 ml urine.
Contact Zoologix if advice is needed to determine an appropriate specimen type for a specific diagnostic application. For specimen types not listed here, please contact Zoologix 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