TY - JOUR
T1 - Multi-site proficiency testing for validation and standardization of assays to detect specific pathogen-free viruses, coronaviruses, and other agents in nonhuman primates
AU - Yee, Jo Ann L.
AU - Grant, Richard
AU - Haertel, Andrew J.
AU - Allers, Carolina
AU - Carpenter, Amanda B.
AU - Van Rompay, Koen K.A.
AU - Roberts, Jeffrey A.
N1 - Funding Information:
We thank Thomas Vanderford, David Lee, Mary Barnes, Kathrine Falkenstein, Elizabeth Didier, Heidi Palmer, Danny De Los Reyes, Kamm Prongay, Luis Giavedoni, Laura Parodi, LaRene Kuller, Peter Nham, Bryson Halley, and other members of the NIH P51 supported National Primate Research Centers Pathogen Detection Working and their laboratory staff for their testing and analysis expertise that made this study possible. The members of the PDWG provided valuable scientific discussion. We thank Sheri Hild from NIH for encouraging, reading, and providing valuable insights for this manuscript.
Funding Information:
This work was supported in part by the Office of Research Infrastructure Programs/OD grant Nos. P51 OD011107 and 5U42OD010990 (California NPRC), P51 OD011092 and U42 OD010426 (Oregon NPRC), P51OD010425 and U42OD011123 (Washington NPRC), and P51OD011104, U42 OD024282, U42OD010568, and U420D011123 (Tulane NPRC).
Publisher Copyright:
© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
PY - 2022/8
Y1 - 2022/8
N2 - In efforts to increase rigor and reproducibility, the USA National Primate Research Centers (NPRCs) have focused on qualification of reagents, cross-laboratory validations, and proficiency testing for methods to detect infectious agents and accompanying immune responses in nonhuman primates. The pathogen detection working group, comprised of laboratory scientists, colony managers, and leaders from the NPRCs, has championed the effort to produce testing that is reliable and consistent across laboratories. Through multi-year efforts with shared proficiency samples, testing percent agreement has increased from as low as 67.1% for SRV testing in 2010 to 92.1% in 2019. The 2019 average agreement for the four basic SPF agents improved to >96% (86.5% BV, 98.9 SIV, 92.1 SRV, and 97.0 STLV). As new pathogens such as SARS coronavirus type 2 emerge, these steps can now be quickly replicated to develop and implement new assays that ensure rigor, reproducibly, and quality for NHP pathogen detection.
AB - In efforts to increase rigor and reproducibility, the USA National Primate Research Centers (NPRCs) have focused on qualification of reagents, cross-laboratory validations, and proficiency testing for methods to detect infectious agents and accompanying immune responses in nonhuman primates. The pathogen detection working group, comprised of laboratory scientists, colony managers, and leaders from the NPRCs, has championed the effort to produce testing that is reliable and consistent across laboratories. Through multi-year efforts with shared proficiency samples, testing percent agreement has increased from as low as 67.1% for SRV testing in 2010 to 92.1% in 2019. The 2019 average agreement for the four basic SPF agents improved to >96% (86.5% BV, 98.9 SIV, 92.1 SRV, and 97.0 STLV). As new pathogens such as SARS coronavirus type 2 emerge, these steps can now be quickly replicated to develop and implement new assays that ensure rigor, reproducibly, and quality for NHP pathogen detection.
KW - PCR
KW - proficiency testing
KW - serology
KW - specific pathogen-free
KW - virus
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U2 - 10.1111/jmp.12586
DO - 10.1111/jmp.12586
M3 - Review article
C2 - 35426147
AN - SCOPUS:85128051041
VL - 51
SP - 234
EP - 245
JO - Journal of Medical Primatology
JF - Journal of Medical Primatology
SN - 0047-2565
IS - 4
ER -