PMID- 36447195
OWN - NLM
STAT- MEDLINE
DCOM- 20221230
LR  - 20221230
IS  - 1471-2458 (Electronic)
IS  - 1471-2458 (Linking)
VI  - 22
IP  - 1
DP  - 2022 Nov 29
TI  - Adapting Lot Quality Assurance Sampling to accommodate imperfect diagnostic 
      tests: application to COVID-19 serosurveillance in Haiti.
PG  - 2221
LID - 10.1186/s12889-022-14206-5 [doi]
LID - 2221
AB  - BACKGROUND: Lot Quality Assurance Sampling (LQAS), a tool used for monitoring 
      health indicators in low resource settings resulting in "high" or "low" 
      classifications, assumes that determination of the trait of interest is perfect. 
      This is often not true for diagnostic tests, with imperfect sensitivity and 
      specificity. Here, we develop Lot Quality Assurance Sampling for Imperfect Tests 
      (LQAS-IMP) to address this issue and apply it to a COVID-19 serosurveillance 
      study design in Haiti. METHODS: We first derive a modified procedure, LQAS-IMP, 
      that accounts for the sensitivity and specificity of a diagnostic test to yield 
      correct classification errors. We then apply the novel LQAS-IMP to design an LQAS 
      system to classify prevalence of SARS-CoV-2 antibodies among healthcare workers 
      at eleven Zanmia Lasante health facilities in Haiti. Finally, we show the 
      performance of the LQAS-IMP procedure in a simulation study. RESULTS: We found 
      that when an imperfect diagnostic test is used, the classification errors in the 
      standard LQAS procedure are larger than specified. In the modified LQAS-IMP 
      procedure, classification errors are consistent with the specified maximum 
      classification error. We then utilized the LQAS-IMP procedure to define valid 
      systems for sampling at eleven hospitals in Haiti. CONCLUSION: The LQAS-IMP 
      procedure accounts for imperfect sensitivity and specificity in system design; if 
      the accuracy of a test is known, the use of LQAS-IMP extends LQAS to applications 
      for indicators that are based on laboratory tests, such as SARS-CoV-2 antibodies.
CI  - (c) 2022. The Author(s).
FAU - Fulcher, Isabel R
AU  - Fulcher IR
AD  - Department of Global Health and Social Medicine, Harvard Medical School, 641 
      Huntington Ave, Boston, MA, USA. isabel_fulcher@hms.harvard.edu.
FAU - Clisbee, Mary
AU  - Clisbee M
AD  - Department of Research, Zanmi Lasante, Santo 18A, Croix-des-Bouquets, Haiti.
FAU - Lambert, Wesler
AU  - Lambert W
AD  - Department of Research, Education and Strategic Information, Santo 18A, 
      Croix-des-Bouquets, Haiti.
FAU - Leandre, Fernet Renand
AU  - Leandre FR
AD  - Department of Global Health and Social Medicine, Harvard Medical School, 641 
      Huntington Ave, Boston, MA, USA.
AD  - Division of Global Health Equity, Brigham and Women's Hospital, 800 Boylston 
      Street Suite 300, Boston, USA.
FAU - Hedt-Gauthier, Bethany
AU  - Hedt-Gauthier B
AD  - Department of Global Health and Social Medicine, Harvard Medical School, 641 
      Huntington Ave, Boston, MA, USA.
AD  - Department of Biostatistics, Harvard T.H. Chan School of Public Health, 677 
      Huntington Ave, Boston, MA, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20221129
PL  - England
TA  - BMC Public Health
JT  - BMC public health
JID - 100968562
RN  - 0 (Antibodies, Viral)
SB  - IM
MH  - Humans
MH  - Antibodies, Viral
MH  - *COVID-19/diagnosis/epidemiology
MH  - Haiti/epidemiology
MH  - *Lot Quality Assurance Sampling
MH  - SARS-CoV-2
PMC - PMC9707425
OTO - NOTNLM
OT  - COVID-19
OT  - Diagnostic testing
OT  - Lot Quality Assurance Sampling
OT  - Serosurveys
COIS- The authors declare that they have no competing interests.
EDAT- 2022/11/30 06:00
MHDA- 2022/12/02 06:00
PMCR- 2022/11/29
CRDT- 2022/11/29 23:54
PHST- 2022/01/22 00:00 [received]
PHST- 2022/09/02 00:00 [accepted]
PHST- 2022/11/29 23:54 [entrez]
PHST- 2022/11/30 06:00 [pubmed]
PHST- 2022/12/02 06:00 [medline]
PHST- 2022/11/29 00:00 [pmc-release]
AID - 10.1186/s12889-022-14206-5 [pii]
AID - 14206 [pii]
AID - 10.1186/s12889-022-14206-5 [doi]
PST - epublish
SO  - BMC Public Health. 2022 Nov 29;22(1):2221. doi: 10.1186/s12889-022-14206-5.