| Autor: |
Alvarado R; Malaria Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA, USA., van den Hoogen LL; Center for Applied Malaria Research and Evaluation, Tropical Medicine Department, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA., Iriemenam NC; Division of Global HIV and TB, Centers for Disease Control and Prevention, Abuja, Nigeria., Akinmulero OO; Institute of Human Virology (IHVN), Central Business District, Abuja, Nigeria., Thomas AN; Institute of Human Virology (IHVN), Central Business District, Abuja, Nigeria., Tamunonengiyeofori I; Nigeria Centre for Disease Control (NCDC), Abuja, Nigeria., Erasogie E; Nigeria Centre for Disease Control (NCDC), Abuja, Nigeria., Chimaoge AC; Nigeria Centre for Disease Control (NCDC), Abuja, Nigeria., Dawurung AB; Institute of Human Virology (IHVN), Central Business District, Abuja, Nigeria., Esiekpe MK; Institute of Human Virology (IHVN), Central Business District, Abuja, Nigeria., Okoli MU; Nigeria Centre for Disease Control (NCDC), Abuja, Nigeria., Mba N; Nigeria Centre for Disease Control (NCDC), Abuja, Nigeria., Ogunniyi A; Nigeria Centre for Disease Control (NCDC), Abuja, Nigeria., Abimiku A; Institute of Human Virology (IHVN), Central Business District, Abuja, Nigeria., Maire M; Malaria Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA, USA., Bassey OO; Division of Global HIV and TB, Centers for Disease Control and Prevention, Abuja, Nigeria., Okoye M; Division of Global HIV and TB, Centers for Disease Control and Prevention, Abuja, Nigeria., Swaminathan M; Division of Global HIV and TB, Centers for Disease Control and Prevention, Abuja, Nigeria., Greby SM; Division of Global HIV and TB, Centers for Disease Control and Prevention, Abuja, Nigeria., Ndodo N; Nigeria Centre for Disease Control (NCDC), Abuja, Nigeria., Ihekweazu C; Nigeria Centre for Disease Control (NCDC), Abuja, Nigeria., Abubakar A; Institute of Human Virology (IHVN), Central Business District, Abuja, Nigeria., Steinhardt L; Malaria Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA, USA., Rogier E; Malaria Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA, USA. erogier@cdc.gov. |
| Abstrakt: |
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. |
