Considerations for quality assurance of multiplex malaria antigen detection assays with large sample sets
Abstract Multiplex assays for malaria antigen detection can gather data from large sample sets, but considerations for the consistency and quality assurance (QA) of mass testing lack evaluation. We present a QA framework for a study occurring November 2019 to March 2020 involving 504 assay plates de...
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Nature Portfolio
2021
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oai:doaj.org-article:77e06d2e66de421ea35fbe36e6f0ff2c2021-12-02T17:14:23ZConsiderations for quality assurance of multiplex malaria antigen detection assays with large sample sets10.1038/s41598-021-92723-w2045-2322https://doaj.org/article/77e06d2e66de421ea35fbe36e6f0ff2c2021-06-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-92723-whttps://doaj.org/toc/2045-2322Abstract Multiplex assays for malaria antigen detection can gather data from large sample sets, but considerations for the consistency and quality assurance (QA) of mass testing lack evaluation. We present a QA framework for a study occurring November 2019 to March 2020 involving 504 assay plates detecting four Plasmodium antigens: pan-Plasmodium aldolase and lactate dehydrogenase (LDH), histidine-rich protein 2 (HRP2), P. vivax LDH (PvLDH). Controls on each plate included buffer blank, antigen negative blood, and 4-point positive dilution curve. The blank and negative blood provided consistently low signal for all targets except for pAldolase, which showed variability. Positive curve signals decreased throughout the 5-month study duration but retained a coefficient of variation (CV) of < 5%, with the exception of HRP2 in month 5 (CV of 11%). Regression fittings for inter-plate control signals provided mean and standard deviations (SDs), and of 504 assay plates, 6 (1.2%) violated the acceptable deviation limits and were repeated. For the 40,272 human blood samples assayed in this study, of 161,088 potential data points (each sample × 4 antigens), 160,641 (99.7%) successfully passed quality checks. The QA framework presented here can be utilized to ensure quality of laboratory antigen detection for large sample sets.Rachel AlvaradoLotus L. van den HoogenNnaemeka C. IriemenamOluwaseun O. AkinmuleroAndrew N. ThomasIsrael TamunonengiyeoforiEvbuomwan ErasogieAchugbu C. ChimaogeAyuba B. DawurungMudiaga K. EsiekpeMary U. OkoliNwando MbaAbiodun OgunniyiAlash’le AbimikuMark MaireOrji O. BasseyMcPaul OkoyeMahesh SwaminathanStacie M. GrebyNnaemeka NdodoChikwe IhekweazuAdo AbubakarLaura SteinhardtEric RogierNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-9 (2021) |
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DOAJ |
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DOAJ |
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EN |
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Medicine R Science Q |
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Medicine R Science Q Rachel Alvarado Lotus L. van den Hoogen Nnaemeka C. Iriemenam Oluwaseun O. Akinmulero Andrew N. Thomas Israel Tamunonengiyeofori Evbuomwan Erasogie Achugbu C. Chimaoge Ayuba B. Dawurung Mudiaga K. Esiekpe Mary U. Okoli Nwando Mba Abiodun Ogunniyi Alash’le Abimiku Mark Maire Orji O. Bassey McPaul Okoye Mahesh Swaminathan Stacie M. Greby Nnaemeka Ndodo Chikwe Ihekweazu Ado Abubakar Laura Steinhardt Eric Rogier Considerations for quality assurance of multiplex malaria antigen detection assays with large sample sets |
| description |
Abstract Multiplex assays for malaria antigen detection can gather data from large sample sets, but considerations for the consistency and quality assurance (QA) of mass testing lack evaluation. We present a QA framework for a study occurring November 2019 to March 2020 involving 504 assay plates detecting four Plasmodium antigens: pan-Plasmodium aldolase and lactate dehydrogenase (LDH), histidine-rich protein 2 (HRP2), P. vivax LDH (PvLDH). Controls on each plate included buffer blank, antigen negative blood, and 4-point positive dilution curve. The blank and negative blood provided consistently low signal for all targets except for pAldolase, which showed variability. Positive curve signals decreased throughout the 5-month study duration but retained a coefficient of variation (CV) of < 5%, with the exception of HRP2 in month 5 (CV of 11%). Regression fittings for inter-plate control signals provided mean and standard deviations (SDs), and of 504 assay plates, 6 (1.2%) violated the acceptable deviation limits and were repeated. For the 40,272 human blood samples assayed in this study, of 161,088 potential data points (each sample × 4 antigens), 160,641 (99.7%) successfully passed quality checks. The QA framework presented here can be utilized to ensure quality of laboratory antigen detection for large sample sets. |
| format |
article |
| author |
Rachel Alvarado Lotus L. van den Hoogen Nnaemeka C. Iriemenam Oluwaseun O. Akinmulero Andrew N. Thomas Israel Tamunonengiyeofori Evbuomwan Erasogie Achugbu C. Chimaoge Ayuba B. Dawurung Mudiaga K. Esiekpe Mary U. Okoli Nwando Mba Abiodun Ogunniyi Alash’le Abimiku Mark Maire Orji O. Bassey McPaul Okoye Mahesh Swaminathan Stacie M. Greby Nnaemeka Ndodo Chikwe Ihekweazu Ado Abubakar Laura Steinhardt Eric Rogier |
| author_facet |
Rachel Alvarado Lotus L. van den Hoogen Nnaemeka C. Iriemenam Oluwaseun O. Akinmulero Andrew N. Thomas Israel Tamunonengiyeofori Evbuomwan Erasogie Achugbu C. Chimaoge Ayuba B. Dawurung Mudiaga K. Esiekpe Mary U. Okoli Nwando Mba Abiodun Ogunniyi Alash’le Abimiku Mark Maire Orji O. Bassey McPaul Okoye Mahesh Swaminathan Stacie M. Greby Nnaemeka Ndodo Chikwe Ihekweazu Ado Abubakar Laura Steinhardt Eric Rogier |
| author_sort |
Rachel Alvarado |
| title |
Considerations for quality assurance of multiplex malaria antigen detection assays with large sample sets |
| title_short |
Considerations for quality assurance of multiplex malaria antigen detection assays with large sample sets |
| title_full |
Considerations for quality assurance of multiplex malaria antigen detection assays with large sample sets |
| title_fullStr |
Considerations for quality assurance of multiplex malaria antigen detection assays with large sample sets |
| title_full_unstemmed |
Considerations for quality assurance of multiplex malaria antigen detection assays with large sample sets |
| title_sort |
considerations for quality assurance of multiplex malaria antigen detection assays with large sample sets |
| publisher |
Nature Portfolio |
| publishDate |
2021 |
| url |
https://doaj.org/article/77e06d2e66de421ea35fbe36e6f0ff2c |
| work_keys_str_mv |
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