Independent clinic-based evaluation of point-of-care testing for the screening of Chlamydia trachomatis, Neisseria gonorrhoea and Trichomonas vaginalis in women-at-risk in Australia, Guatemala, Morocco, and South Africa
Abstract Background In 2018, the World Health Organization commenced a multi-country validation study of the Cepheid GeneXpert for a range of molecular-based point-of-care (POC) tests in primary care settings. One study arm focused on the evaluation of POC tests for screening ‘women at risk’ for chl...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2024-03-01
|
| Series: | BMC Infectious Diseases |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12879-024-09018-4 |
| _version_ | 1827328457432891392 |
|---|---|
| author | Mark Shephard Susan Matthews Ranmini Kularatne Kelly Andrewartha Karel Blondeel Christian Alvarez Elsy Camey Amina Hançali Etienne Müller Aurelie Haw Hicham Oumzil Daniel Golparian Dorian E Ramirez James Kiarie Firdavs Kurbonov Massimo Mirandola Rosanna W Peeling Ronaldo Silva Soe Soe Thwin Magnus Unemo Igor Toskin |
| author_facet | Mark Shephard Susan Matthews Ranmini Kularatne Kelly Andrewartha Karel Blondeel Christian Alvarez Elsy Camey Amina Hançali Etienne Müller Aurelie Haw Hicham Oumzil Daniel Golparian Dorian E Ramirez James Kiarie Firdavs Kurbonov Massimo Mirandola Rosanna W Peeling Ronaldo Silva Soe Soe Thwin Magnus Unemo Igor Toskin |
| author_sort | Mark Shephard |
| collection | DOAJ |
| description | Abstract Background In 2018, the World Health Organization commenced a multi-country validation study of the Cepheid GeneXpert for a range of molecular-based point-of-care (POC) tests in primary care settings. One study arm focused on the evaluation of POC tests for screening ‘women at risk’ for chlamydia (CT), gonorrhoea (NG) and trichomonas (TV) in four countries – Australia, Guatemala, Morocco and South Africa. Methods Study participants completed a pre-test questionnaire which included demographics, clinical information and general questions on POC testing (POCT). Two vaginal swab samples (either self-collected or clinician collected) from each patient were tested on the GeneXpert at the POC and at a reference laboratory using quality-assured nucleic acid amplification tests (NAATs). Results One thousand three hundred and eighty-three women were enrolled: 58.6% from South Africa, 29.2% from Morocco, 6.2% from Guatemala, and 6.0% from Australia. 1296 samples for CT/NG and 1380 samples for TV were tested by the GeneXpert and the reference NAAT. The rate of unsuccessful tests on the GeneXpert was 1.9% for CT, 1.5% for NG and 0.96% for TV. The prevalence of CT, NG and TV was 31%, 13% and 23%, respectively. 1.5% of samples were positive for all three infections; 7.8% were positive for CT and NG; 2.4% were positive for NG and TV; and 7.3% were positive for CT and TV. Compared to reference NAATs, pooled estimates of sensitivity for the GeneXpert tests were 83.7% (95% confidence intervals 69.2-92.1) for CT, 90.5% (85.1-94.1) for NG and 64.7% (58.1-70.7) for TV (although estimates varied considerably between countries). Estimates for specificity were ≥96% for all three tests both within- and between-countries. Pooled positive and negative likelihood ratios were: 32.7 ([CI] 21.2-50.5) and 0.17 (0.08-0.33) for CT; 95.3 (36.9-245.7) and 0.10 (0.06-0.15) for NG; and 56.5 (31.6-101.1) and 0.35 (0.27-0.47) for TV. Conclusion This multi-country evaluation is the first of its kind world-wide. Positive likelihood ratios, as well as specificity estimates, indicate the GeneXpert POC test results for CT, NG and TV were clinically acceptable for ruling in the presence of disease. However, negative likelihood ratios and variable sensitivity estimates from this study were poorer than expected for ruling out these infections, particularly for TV. Trial registration Ethics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee, as well as local ethics committees from all participating countries. |
| first_indexed | 2024-03-07T15:18:11Z |
| format | Article |
| id | doaj.art-90395e61201249f382638ebdfece5e28 |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-03-07T15:18:11Z |
| publishDate | 2024-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-90395e61201249f382638ebdfece5e282024-03-05T17:49:57ZengBMCBMC Infectious Diseases1471-23342024-03-0124S111210.1186/s12879-024-09018-4Independent clinic-based evaluation of point-of-care testing for the screening of Chlamydia trachomatis, Neisseria gonorrhoea and Trichomonas vaginalis in women-at-risk in Australia, Guatemala, Morocco, and South AfricaMark Shephard0Susan Matthews1Ranmini Kularatne2Kelly Andrewartha3Karel Blondeel4Christian Alvarez5Elsy Camey6Amina Hançali7Etienne Müller8Aurelie Haw9Hicham Oumzil10Daniel Golparian11Dorian E Ramirez12James Kiarie13Firdavs Kurbonov14Massimo Mirandola15Rosanna W Peeling16Ronaldo Silva17Soe Soe Thwin18Magnus Unemo19Igor Toskin20International Centre for Point-of-Care Testing, Flinders UniversityInternational Centre for Point-of-Care Testing, Flinders UniversityCentre for HIV & STI, National Institute for Communicable DiseasesInternational Centre for Point-of-Care Testing, Flinders UniversityDepartment of Sexual and Reproductive Health and Research, World Health OrganizationSida y Sociedad, ONG (SISO)Sida y Sociedad, ONG (SISO)National Institute for HealthCentre for HIV & STI, National Institute for Communicable DiseasesMédecins sans FrontièresNational Institute for HealthWHO Collaborating Centre for Gonorrhoea and other STIs, Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro UniversityFacultad de Ciencias Médicas, Universidad de San Carlos de GuatemalaDepartment of Sexual and Reproductive Health and Research, World Health OrganizationDepartment of Sexual and Reproductive Health and Research, World Health OrganizationInfectious Diseases Section, Department of Diagnostics and Public Health, University of VeronaDepartment of Clinical Research, London School of Hygiene and Tropical MedicineDepartment of Sexual and Reproductive Health and Research, World Health OrganizationDepartment of Sexual and Reproductive Health and Research, World Health OrganizationWHO Collaborating Centre for Gonorrhoea and other STIs, Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro UniversityDepartment of Sexual and Reproductive Health and Research, World Health OrganizationAbstract Background In 2018, the World Health Organization commenced a multi-country validation study of the Cepheid GeneXpert for a range of molecular-based point-of-care (POC) tests in primary care settings. One study arm focused on the evaluation of POC tests for screening ‘women at risk’ for chlamydia (CT), gonorrhoea (NG) and trichomonas (TV) in four countries – Australia, Guatemala, Morocco and South Africa. Methods Study participants completed a pre-test questionnaire which included demographics, clinical information and general questions on POC testing (POCT). Two vaginal swab samples (either self-collected or clinician collected) from each patient were tested on the GeneXpert at the POC and at a reference laboratory using quality-assured nucleic acid amplification tests (NAATs). Results One thousand three hundred and eighty-three women were enrolled: 58.6% from South Africa, 29.2% from Morocco, 6.2% from Guatemala, and 6.0% from Australia. 1296 samples for CT/NG and 1380 samples for TV were tested by the GeneXpert and the reference NAAT. The rate of unsuccessful tests on the GeneXpert was 1.9% for CT, 1.5% for NG and 0.96% for TV. The prevalence of CT, NG and TV was 31%, 13% and 23%, respectively. 1.5% of samples were positive for all three infections; 7.8% were positive for CT and NG; 2.4% were positive for NG and TV; and 7.3% were positive for CT and TV. Compared to reference NAATs, pooled estimates of sensitivity for the GeneXpert tests were 83.7% (95% confidence intervals 69.2-92.1) for CT, 90.5% (85.1-94.1) for NG and 64.7% (58.1-70.7) for TV (although estimates varied considerably between countries). Estimates for specificity were ≥96% for all three tests both within- and between-countries. Pooled positive and negative likelihood ratios were: 32.7 ([CI] 21.2-50.5) and 0.17 (0.08-0.33) for CT; 95.3 (36.9-245.7) and 0.10 (0.06-0.15) for NG; and 56.5 (31.6-101.1) and 0.35 (0.27-0.47) for TV. Conclusion This multi-country evaluation is the first of its kind world-wide. Positive likelihood ratios, as well as specificity estimates, indicate the GeneXpert POC test results for CT, NG and TV were clinically acceptable for ruling in the presence of disease. However, negative likelihood ratios and variable sensitivity estimates from this study were poorer than expected for ruling out these infections, particularly for TV. Trial registration Ethics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee, as well as local ethics committees from all participating countries.https://doi.org/10.1186/s12879-024-09018-4Point-of-care testingSexually transmitted infectionsGeneXpertMulti-countrySensitivitySpecificity |
| spellingShingle | Mark Shephard Susan Matthews Ranmini Kularatne Kelly Andrewartha Karel Blondeel Christian Alvarez Elsy Camey Amina Hançali Etienne Müller Aurelie Haw Hicham Oumzil Daniel Golparian Dorian E Ramirez James Kiarie Firdavs Kurbonov Massimo Mirandola Rosanna W Peeling Ronaldo Silva Soe Soe Thwin Magnus Unemo Igor Toskin Independent clinic-based evaluation of point-of-care testing for the screening of Chlamydia trachomatis, Neisseria gonorrhoea and Trichomonas vaginalis in women-at-risk in Australia, Guatemala, Morocco, and South Africa BMC Infectious Diseases Point-of-care testing Sexually transmitted infections GeneXpert Multi-country Sensitivity Specificity |
| title | Independent clinic-based evaluation of point-of-care testing for the screening of Chlamydia trachomatis, Neisseria gonorrhoea and Trichomonas vaginalis in women-at-risk in Australia, Guatemala, Morocco, and South Africa |
| title_full | Independent clinic-based evaluation of point-of-care testing for the screening of Chlamydia trachomatis, Neisseria gonorrhoea and Trichomonas vaginalis in women-at-risk in Australia, Guatemala, Morocco, and South Africa |
| title_fullStr | Independent clinic-based evaluation of point-of-care testing for the screening of Chlamydia trachomatis, Neisseria gonorrhoea and Trichomonas vaginalis in women-at-risk in Australia, Guatemala, Morocco, and South Africa |
| title_full_unstemmed | Independent clinic-based evaluation of point-of-care testing for the screening of Chlamydia trachomatis, Neisseria gonorrhoea and Trichomonas vaginalis in women-at-risk in Australia, Guatemala, Morocco, and South Africa |
| title_short | Independent clinic-based evaluation of point-of-care testing for the screening of Chlamydia trachomatis, Neisseria gonorrhoea and Trichomonas vaginalis in women-at-risk in Australia, Guatemala, Morocco, and South Africa |
| title_sort | independent clinic based evaluation of point of care testing for the screening of chlamydia trachomatis neisseria gonorrhoea and trichomonas vaginalis in women at risk in australia guatemala morocco and south africa |
| topic | Point-of-care testing Sexually transmitted infections GeneXpert Multi-country Sensitivity Specificity |
| url | https://doi.org/10.1186/s12879-024-09018-4 |
| work_keys_str_mv | AT markshephard independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT susanmatthews independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT ranminikularatne independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT kellyandrewartha independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT karelblondeel independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT christianalvarez independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT elsycamey independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT aminahancali independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT etiennemuller independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT aureliehaw independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT hichamoumzil independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT danielgolparian independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT dorianeramirez independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT jameskiarie independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT firdavskurbonov independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT massimomirandola independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT rosannawpeeling independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT ronaldosilva independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT soesoethwin independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT magnusunemo independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica AT igortoskin independentclinicbasedevaluationofpointofcaretestingforthescreeningofchlamydiatrachomatisneisseriagonorrhoeaandtrichomonasvaginalisinwomenatriskinaustraliaguatemalamoroccoandsouthafrica |