Collaborative study for the characterization of a chikungunya virus RNA reference reagent for use in nucleic acid testing

The Chikungunya virus Collaborative Study Group

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Background and Objectives: Infections with the mosquito-borne chikungunya virus (CHIKV) can cause febrile illness or be asymptomatic. Laboratory diagnosis of CHIKV is often made with laboratory-developed nucleic acid amplification technology (NAT) assays because there are no U.S. Food and Drug Administration (FDA)-approved diagnostic or blood screening assays. We aimed to produce a well-characterized CHIKV RNA reference reagent (CHIKV-RR) for use in NAT assays. Materials and Methods: A CHIKV RNA-RR consisting of cell culture-grown, heat-inactivated CHIKV diluted in human plasma was assessed by 8 laboratories in a collaborative study. The participants were asked to test the CHIKV-RR using their NAT assay(s) by qualitative testing (determination of RNA end-point by testing log and half-log dilutions followed by calculation of estimated NAT-detectable units/ml, after adjustment for the sample volume used for testing), and by quantitative testing, when available. Results: Results from the testing showed that the CHIKV-RR had an estimated overall mean of 7·56 log10 detectable units/ml, ranging from 6·2 log10 to 8·6 log10. Conclusions: The Center for Biologics for Evaluation and Research/FDA CHIKV RNA-RR for NAT was established with a concentration of 7·56 log10 detectable units/ml.

Original languageEnglish (US)
Pages (from-to)312-318
Number of pages7
JournalVox Sanguinis
Volume109
Issue number4
DOIs
StatePublished - Nov 1 2015

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Chikungunya virus
Nucleic Acids
RNA
Technology
United States Food and Drug Administration
Endpoint Determination
Clinical Laboratory Techniques
Culicidae
Biological Products
Fever
Cell Culture Techniques
Hot Temperature

Keywords

  • Chikungunya virus
  • Nucleic acid amplification tests
  • Reference standards

ASJC Scopus subject areas

  • Hematology

Cite this

Collaborative study for the characterization of a chikungunya virus RNA reference reagent for use in nucleic acid testing. / The Chikungunya virus Collaborative Study Group.

In: Vox Sanguinis, Vol. 109, No. 4, 01.11.2015, p. 312-318.

Research output: Contribution to journalArticle

The Chikungunya virus Collaborative Study Group. / Collaborative study for the characterization of a chikungunya virus RNA reference reagent for use in nucleic acid testing. In: Vox Sanguinis. 2015 ; Vol. 109, No. 4. pp. 312-318.
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abstract = "Background and Objectives: Infections with the mosquito-borne chikungunya virus (CHIKV) can cause febrile illness or be asymptomatic. Laboratory diagnosis of CHIKV is often made with laboratory-developed nucleic acid amplification technology (NAT) assays because there are no U.S. Food and Drug Administration (FDA)-approved diagnostic or blood screening assays. We aimed to produce a well-characterized CHIKV RNA reference reagent (CHIKV-RR) for use in NAT assays. Materials and Methods: A CHIKV RNA-RR consisting of cell culture-grown, heat-inactivated CHIKV diluted in human plasma was assessed by 8 laboratories in a collaborative study. The participants were asked to test the CHIKV-RR using their NAT assay(s) by qualitative testing (determination of RNA end-point by testing log and half-log dilutions followed by calculation of estimated NAT-detectable units/ml, after adjustment for the sample volume used for testing), and by quantitative testing, when available. Results: Results from the testing showed that the CHIKV-RR had an estimated overall mean of 7·56 log10 detectable units/ml, ranging from 6·2 log10 to 8·6 log10. Conclusions: The Center for Biologics for Evaluation and Research/FDA CHIKV RNA-RR for NAT was established with a concentration of 7·56 log10 detectable units/ml.",
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AU - The Chikungunya virus Collaborative Study Group

AU - Añez, G.

AU - Jiang, Z.

AU - Heisey, D. A R

AU - Kerby, S.

AU - Rios, Maria

AU - Drebot, M.

AU - Holloway, K.

AU - Lindsay, R.

AU - Makowski, K.

AU - Dugenny, S.

AU - Petrich, D.

AU - Kramer, L. D.

AU - Zink, S.

AU - St.George, K.

AU - Dean, A.

AU - Zeng, L.

AU - Linnen, J.

AU - Bres, V.

AU - Powers, A.

AU - Ledermann, J.

AU - Weaver, Scott

AU - Langsjoen, Rose

AU - Seymour, Robert

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N2 - Background and Objectives: Infections with the mosquito-borne chikungunya virus (CHIKV) can cause febrile illness or be asymptomatic. Laboratory diagnosis of CHIKV is often made with laboratory-developed nucleic acid amplification technology (NAT) assays because there are no U.S. Food and Drug Administration (FDA)-approved diagnostic or blood screening assays. We aimed to produce a well-characterized CHIKV RNA reference reagent (CHIKV-RR) for use in NAT assays. Materials and Methods: A CHIKV RNA-RR consisting of cell culture-grown, heat-inactivated CHIKV diluted in human plasma was assessed by 8 laboratories in a collaborative study. The participants were asked to test the CHIKV-RR using their NAT assay(s) by qualitative testing (determination of RNA end-point by testing log and half-log dilutions followed by calculation of estimated NAT-detectable units/ml, after adjustment for the sample volume used for testing), and by quantitative testing, when available. Results: Results from the testing showed that the CHIKV-RR had an estimated overall mean of 7·56 log10 detectable units/ml, ranging from 6·2 log10 to 8·6 log10. Conclusions: The Center for Biologics for Evaluation and Research/FDA CHIKV RNA-RR for NAT was established with a concentration of 7·56 log10 detectable units/ml.

AB - Background and Objectives: Infections with the mosquito-borne chikungunya virus (CHIKV) can cause febrile illness or be asymptomatic. Laboratory diagnosis of CHIKV is often made with laboratory-developed nucleic acid amplification technology (NAT) assays because there are no U.S. Food and Drug Administration (FDA)-approved diagnostic or blood screening assays. We aimed to produce a well-characterized CHIKV RNA reference reagent (CHIKV-RR) for use in NAT assays. Materials and Methods: A CHIKV RNA-RR consisting of cell culture-grown, heat-inactivated CHIKV diluted in human plasma was assessed by 8 laboratories in a collaborative study. The participants were asked to test the CHIKV-RR using their NAT assay(s) by qualitative testing (determination of RNA end-point by testing log and half-log dilutions followed by calculation of estimated NAT-detectable units/ml, after adjustment for the sample volume used for testing), and by quantitative testing, when available. Results: Results from the testing showed that the CHIKV-RR had an estimated overall mean of 7·56 log10 detectable units/ml, ranging from 6·2 log10 to 8·6 log10. Conclusions: The Center for Biologics for Evaluation and Research/FDA CHIKV RNA-RR for NAT was established with a concentration of 7·56 log10 detectable units/ml.

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