External quality assessment to support the WHO ProSPeRo study for the evaluation of two dual HIV/syphilis point-of-care tests in seven countries.
Dried tube specimens (DTS)
Dual HIV/syphilis assay
External Quality Assurance (EQA)
Point-of-care diagnostic tests (POCTs)
Sexually transmitted infections (STIs)
Journal
BMC infectious diseases
ISSN: 1471-2334
Titre abrégé: BMC Infect Dis
Pays: England
ID NLM: 100968551
Informations de publication
Date de publication:
29 Feb 2024
29 Feb 2024
Historique:
received:
27
07
2022
accepted:
17
01
2024
medline:
1
3
2024
pubmed:
29
2
2024
entrez:
28
2
2024
Statut:
epublish
Résumé
Sexually transmitted infections (STIs) such as syphilis and HIV remain to be a significant public health issue worldwide. Dual rapid point-of-care tests (POCTs) have shown promise for detecting antibodies to HIV and syphilis but have not been fully evaluated in the field. Our study supported the WHO ProSPeRo study on Sexually Transmitted Infection Point-of-Care Testing (STI POCT) by providing external quality assessment (EQA) for HIV and syphilis testing in reference laboratories and their associated clinical sites in seven countries. HIV/syphilis serum liquid and dried tube specimen (DTS) panels were prepared by CDC. Liquid panels were distributed to the reference laboratories for three rounds of testing using commercially and locally available laboratory-based serological tests. DTS panels were sent to the clinical testing sites for 8 rounds of POC testing using the Abbott SD BIOLINE HIV/Syphilis Duo test (hereafter referred to as SD BIOLINE) and the Chembio Dual Path Platform (DPP) HIV-Syphilis assay. EQA panels were tested at CDC using the Rapid Plasma Reagin (RPR) test and the Treponema pallidum Particle Agglutination assay (TP-PA) for syphilis antibodies. Genetic Systems HIV-1/HIV-2 Plus O EIA, Geenius HIV Supplemental Assay and the Oraquick Advance HIV test were used to detect HIV antibodies in the EQA panels. Results from the reference laboratories and POCT sites were compared to those obtained at the CDC and a percentage agreement was calculated. Qualitative RPR and TP-PA performed at the reference laboratories demonstrated 95.4-100% agreement with CDC results while quantitative RPR and TP-PA tests demonstrated 87.7% and 89.2% agreement, respectively. A 93.8% concordance rate was observed for qualitative HIV testing in laboratories. EQA testing at clinical sites using dual tests showed 98.7% and 99.1% agreement for detection of HIV antibodies and eight out of 10 sites had > 95.8% agreement for syphilis testing. However, two clinical sites showed only 65.0-66.7% agreement for SD BIOLINE and 84.0-86.7% for DPP, respectively, for syphilis testing. Overall, laboratories demonstrated high EQA performance in this study. Both HIV/syphilis POCTs gave expected results in the clinic-based evaluations using DTS. However, testing errors were identified in a few testing sites suggesting the necessity for continuous training and monitoring the quality of POC testing.
Sections du résumé
BACKGROUND
BACKGROUND
Sexually transmitted infections (STIs) such as syphilis and HIV remain to be a significant public health issue worldwide. Dual rapid point-of-care tests (POCTs) have shown promise for detecting antibodies to HIV and syphilis but have not been fully evaluated in the field. Our study supported the WHO ProSPeRo study on Sexually Transmitted Infection Point-of-Care Testing (STI POCT) by providing external quality assessment (EQA) for HIV and syphilis testing in reference laboratories and their associated clinical sites in seven countries.
METHODS
METHODS
HIV/syphilis serum liquid and dried tube specimen (DTS) panels were prepared by CDC. Liquid panels were distributed to the reference laboratories for three rounds of testing using commercially and locally available laboratory-based serological tests. DTS panels were sent to the clinical testing sites for 8 rounds of POC testing using the Abbott SD BIOLINE HIV/Syphilis Duo test (hereafter referred to as SD BIOLINE) and the Chembio Dual Path Platform (DPP) HIV-Syphilis assay. EQA panels were tested at CDC using the Rapid Plasma Reagin (RPR) test and the Treponema pallidum Particle Agglutination assay (TP-PA) for syphilis antibodies. Genetic Systems HIV-1/HIV-2 Plus O EIA, Geenius HIV Supplemental Assay and the Oraquick Advance HIV test were used to detect HIV antibodies in the EQA panels. Results from the reference laboratories and POCT sites were compared to those obtained at the CDC and a percentage agreement was calculated.
RESULTS
RESULTS
Qualitative RPR and TP-PA performed at the reference laboratories demonstrated 95.4-100% agreement with CDC results while quantitative RPR and TP-PA tests demonstrated 87.7% and 89.2% agreement, respectively. A 93.8% concordance rate was observed for qualitative HIV testing in laboratories. EQA testing at clinical sites using dual tests showed 98.7% and 99.1% agreement for detection of HIV antibodies and eight out of 10 sites had > 95.8% agreement for syphilis testing. However, two clinical sites showed only 65.0-66.7% agreement for SD BIOLINE and 84.0-86.7% for DPP, respectively, for syphilis testing.
CONCLUSIONS
CONCLUSIONS
Overall, laboratories demonstrated high EQA performance in this study. Both HIV/syphilis POCTs gave expected results in the clinic-based evaluations using DTS. However, testing errors were identified in a few testing sites suggesting the necessity for continuous training and monitoring the quality of POC testing.
Identifiants
pubmed: 38418989
doi: 10.1186/s12879-024-09027-3
pii: 10.1186/s12879-024-09027-3
pmc: PMC10902925
doi:
Substances chimiques
HIV Antibodies
0
Antibodies, Bacterial
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
194Subventions
Organisme : World Health Organization
ID : 001
Pays : International
Informations de copyright
© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.
Références
BMJ Open. 2020 Nov 26;10(11):e044479
pubmed: 33243821
Int J STD AIDS. 2019 Mar;30(4):323-328
pubmed: 30472926
Int J Gynaecol Obstet. 1998 Dec;63(3):247-52
pubmed: 9989893
Sex Transm Infect. 2017 Dec;93(S4):S81-S88
pubmed: 29223966
Lancet Glob Health. 2021 Jan;9(1):e61-e71
pubmed: 33227254
Sex Transm Dis. 2006 Mar;33(3):143-8
pubmed: 16505739
J Virol Methods. 2010 Feb;163(2):295-300
pubmed: 19878697
Lancet Glob Health. 2016 Aug;4(8):e525-33
pubmed: 27443780
Clin Microbiol Rev. 2018 Nov 28;32(1):
pubmed: 30487166
Sex Transm Dis. 2018 Dec;45(12):829-833
pubmed: 29944643
Int Immunopharmacol. 2014 Jun;20(2):331-6
pubmed: 24690532
Med Care. 2010 Dec;48(12):1071-9
pubmed: 21063228
Arch Intern Med. 2012 Sep 10;172(16):1237-43
pubmed: 22826097
J Infect Dis. 1992 Jun;165(6):1124-6
pubmed: 1583332
Int J STD AIDS. 1995 Jul-Aug;6(4):241-8
pubmed: 7548285
Asian J Transfus Sci. 2015 Jan-Jun;9(1):109
pubmed: 25722593
BMC Infect Dis. 2019 Jan 3;19(1):1
pubmed: 30606108
J Clin Pathol. 1970 Feb;23(1):31-4
pubmed: 4909102
BMJ Open. 2020 Jan 9;10(1):e029434
pubmed: 31924629
Clin Vaccine Immunol. 2015 Feb;22(2):137-47
pubmed: 25428245
Sex Transm Infect. 2014 Feb;90(1):14-8
pubmed: 24031029
Sex Transm Infect. 2021 Nov;97(7):525-533
pubmed: 33219164
Rev Panam Salud Publica. 2016 Dec;40(6):455-461
pubmed: 28718495