External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance
Nucleic acid testing (NAT) for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
Public Library of Science
2014
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| _version_ | 1826303181889470464 |
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| author | Murphy, S Hermsen, C Douglas, A Edwards, N Petersen, I Fahle, G Adams, M Berry, A Billman, Z Gilbert, S Laurens, M Leroy, O Lyke, K Plowe, C Seilie, A Strauss, K Teelen, K Hill, A Sauerwein, R |
| author_facet | Murphy, S Hermsen, C Douglas, A Edwards, N Petersen, I Fahle, G Adams, M Berry, A Billman, Z Gilbert, S Laurens, M Leroy, O Lyke, K Plowe, C Seilie, A Strauss, K Teelen, K Hill, A Sauerwein, R |
| author_sort | Murphy, S |
| collection | OXFORD |
| description | Nucleic acid testing (NAT) for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA) program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally <0.5 log10 parasites/mL except for one laboratory where the EQA effort identified likely reasons for a general quantitative shift. The within-laboratory variation for all assays was low at <10% coefficient of variation across a range of parasite densities. Based on this study, we propose to create a Molecular Malaria Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide. |
| first_indexed | 2024-03-07T05:58:46Z |
| format | Journal article |
| id | oxford-uuid:eb73de8b-9b81-478e-9488-f7b2b8d5e25b |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T05:58:46Z |
| publishDate | 2014 |
| publisher | Public Library of Science |
| record_format | dspace |
| spelling | oxford-uuid:eb73de8b-9b81-478e-9488-f7b2b8d5e25b2022-03-27T11:09:47ZExternal quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillanceJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:eb73de8b-9b81-478e-9488-f7b2b8d5e25bEnglishSymplectic Elements at OxfordPublic Library of Science2014Murphy, SHermsen, CDouglas, AEdwards, NPetersen, IFahle, GAdams, MBerry, ABillman, ZGilbert, SLaurens, MLeroy, OLyke, KPlowe, CSeilie, AStrauss, KTeelen, KHill, ASauerwein, RNucleic acid testing (NAT) for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA) program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally <0.5 log10 parasites/mL except for one laboratory where the EQA effort identified likely reasons for a general quantitative shift. The within-laboratory variation for all assays was low at <10% coefficient of variation across a range of parasite densities. Based on this study, we propose to create a Molecular Malaria Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide. |
| spellingShingle | Murphy, S Hermsen, C Douglas, A Edwards, N Petersen, I Fahle, G Adams, M Berry, A Billman, Z Gilbert, S Laurens, M Leroy, O Lyke, K Plowe, C Seilie, A Strauss, K Teelen, K Hill, A Sauerwein, R External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance |
| title | External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance |
| title_full | External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance |
| title_fullStr | External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance |
| title_full_unstemmed | External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance |
| title_short | External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance |
| title_sort | external quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance |
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