Conference Material > Poster
Kumari J, Singhal C, Pandey S, Angrup A, Kannan R, et al.
MSF Scientific Days Asia. 2024 November 8
Journal Article > ResearchFull Text
Lancet Infect Dis. 2024 September 1; Volume 24 (Issue 9); 1037-1044.; DOI:10.1016/S1473-3099(24)00184-1
Elsinga J, Sunyoto T, di Stefano L, Giorgetti PF, Kyi HA, et al.
Lancet Infect Dis. 2024 September 1; Volume 24 (Issue 9); 1037-1044.; DOI:10.1016/S1473-3099(24)00184-1
BACKGROUND
Lassa fever is a viral haemorrhagic fever with few options for diagnosis and treatment; it is also under-researched with knowledge gaps on its epidemiology. A point-of-care bedside test diagnosing Lassa fever, adhering to REASSURED criteria, is not currently available but is urgently needed in west African regions with high Lassa fever burden. We aimed to assess the validity and feasibility of a rapid diagnostic test (RDT) to confirm Lassa fever in people in Nigeria.
METHODS
We estimated the diagnostic performance of the ReLASV Pan-Lassa RDT (Zalgen Labs, Frederick, MD, USA) as a research-use-only test, compared to RT-PCR as a reference standard, in 217 participants at a federal tertiary hospital in Abakaliki, Nigeria. We recruited participants between Feb 17, 2022, and April 17, 2023. The RDT was performed using capillary blood at the patient bedside and using plasma at the laboratory. The performance of the test, based on REASSURED criteria, was assessed for user friendliness, rapidity and robustness, sensitivity, and specificity.
FINDINGS
Participants were aged between 0 and 85 years, with a median age of 33·0 years (IQR 22·0-44·3), and 24 participants were younger than 18 years. 107 (50%) participants were women and 109 (50%) were men; one participant had missing sex data. Although the specificity of the Pan-Lassa RDT was high (>90%), sensitivity at bedside using capillary blood was estimated as 4% (95% CI 1-14) at 15 min and 10% (3-22) at 25 min, far below the target of 90%. The laboratory-based RDT using plasma showed better sensitivity (46% [32-61] at 15 min and 50% [36-64] at 25 min) but did not reach the target sensitivity. Among the 52 PCR-positive participants with Lassa fever, positive RDT results were associated with lower cycle threshold values (glycoprotein precursor [GPC] gene mean 30·3 [SD 4·3], Large [L] gene mean 32·3 [3·7] vs GPC gene mean 24·5 [3·9], L gene mean 28·0 [3·6]). Personnel conducting the bedside test procedure reported being hindered by the inconvenient use of full personal protective equipment and long waiting procedures before a result could be read.
INTERPRETATION
The Pan-Lassa RDT is not currently recommended as a diagnostic or screening tool for suspected Lassa fever cases. Marked improvement in sensitivity and user friendliness is needed for the RDT to be adopted clinically. There remains an urgent need for better Lassa fever diagnostics to promote safety of in-hospital care and better disease outcomes in low-resource settings.
Lassa fever is a viral haemorrhagic fever with few options for diagnosis and treatment; it is also under-researched with knowledge gaps on its epidemiology. A point-of-care bedside test diagnosing Lassa fever, adhering to REASSURED criteria, is not currently available but is urgently needed in west African regions with high Lassa fever burden. We aimed to assess the validity and feasibility of a rapid diagnostic test (RDT) to confirm Lassa fever in people in Nigeria.
METHODS
We estimated the diagnostic performance of the ReLASV Pan-Lassa RDT (Zalgen Labs, Frederick, MD, USA) as a research-use-only test, compared to RT-PCR as a reference standard, in 217 participants at a federal tertiary hospital in Abakaliki, Nigeria. We recruited participants between Feb 17, 2022, and April 17, 2023. The RDT was performed using capillary blood at the patient bedside and using plasma at the laboratory. The performance of the test, based on REASSURED criteria, was assessed for user friendliness, rapidity and robustness, sensitivity, and specificity.
FINDINGS
Participants were aged between 0 and 85 years, with a median age of 33·0 years (IQR 22·0-44·3), and 24 participants were younger than 18 years. 107 (50%) participants were women and 109 (50%) were men; one participant had missing sex data. Although the specificity of the Pan-Lassa RDT was high (>90%), sensitivity at bedside using capillary blood was estimated as 4% (95% CI 1-14) at 15 min and 10% (3-22) at 25 min, far below the target of 90%. The laboratory-based RDT using plasma showed better sensitivity (46% [32-61] at 15 min and 50% [36-64] at 25 min) but did not reach the target sensitivity. Among the 52 PCR-positive participants with Lassa fever, positive RDT results were associated with lower cycle threshold values (glycoprotein precursor [GPC] gene mean 30·3 [SD 4·3], Large [L] gene mean 32·3 [3·7] vs GPC gene mean 24·5 [3·9], L gene mean 28·0 [3·6]). Personnel conducting the bedside test procedure reported being hindered by the inconvenient use of full personal protective equipment and long waiting procedures before a result could be read.
INTERPRETATION
The Pan-Lassa RDT is not currently recommended as a diagnostic or screening tool for suspected Lassa fever cases. Marked improvement in sensitivity and user friendliness is needed for the RDT to be adopted clinically. There remains an urgent need for better Lassa fever diagnostics to promote safety of in-hospital care and better disease outcomes in low-resource settings.
Conference Material > Poster
Niykayo LF, Mahajan R, Sagrado MJ, Ajack YBP, Chol BT, et al.
MSF Paediatric Days 2024. 2024 May 3; DOI:10.57740/CO9XKuY
Conference Material > Poster
Phillip E, Adede J, Onduto S, Ochola C, Simba R, et al.
MSF Paediatric Days 2024. 2024 May 3; DOI:10.57740/w8leOu
Conference Material > Poster
Branthwaite C, Alasri H, Naif M, Schwanfelder C
MSF Paediatric Days 2024. 2024 May 3; DOI:10.57740/mhQfPz4Ph
Journal Article > ResearchFull Text
BMC Infect Dis. 2024 March 4; Volume 24 (Issue S1); 277.; DOI:10.1186/s12879-024-09018-4
Shephard M, Matthews S, Kularatne R, Andrewartha K, Blondeel K, et al.
BMC Infect Dis. 2024 March 4; Volume 24 (Issue S1); 277.; DOI:10.1186/s12879-024-09018-4
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. 1,296 samples for CT/NG and 1,380 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.
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. 1,296 samples for CT/NG and 1,380 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.
Journal Article > ResearchFull Text
Public Health Action. 2024 March 1; Volume 14 (Issue 1); 14-19.; DOI:10.5588/pha.23.0022
Tsorou C, Williams A, van den Boogaard W, Staderini N, Repetto E, et al.
Public Health Action. 2024 March 1; Volume 14 (Issue 1); 14-19.; DOI:10.5588/pha.23.0022
SETTING
Sexually transmitted infections (STIs) can impact individuals of any demographic. The most common pathogens causing STIs are Chlamydia trachomatis, Neisseria gonorrhea and Trichomonas vaginalis; these can be treated with specific antibiotics.
OBJECTIVE
To compare the GeneXpert CT/NG test-and-treat algorithm to the syndromic approach algorithm and their impact on antibiotic prescription for gonorrhoea and chlamydia STIs.
DESIGN
A retrospective observational study on women aged ≥18 years who accessed the Médecins Sans Frontières Day Care Centre in Athens with complaints related to urogenital infections between January 2021 and March 2022. Women with abnormal vaginal discharge, excluding clinically diagnosed candidiasis, were eligible for Xpert CT/NG testing.
RESULTS
Of the 450 women who accessed care, 84 were eligible for Xpert CT/NG testing, and only one was positive for chlamydia, therefore resulting in saving 81 doses of ceftriaxone and azithromycin, and 19 doses of metronidazole. The cost of Xpert CT/NG testing, including treatment was €4,606.37, while full antibiotic treatment would have costed €536.76.
CONCLUSION
The overall cost of the Xpert CT/NG test-and-treat algorithm was higher than the syndromic approach. However, quality of care should be weighed against the potential benefits of testing and syndromic treatment to determine the best option for each patient; we therefore advocate for decreasing the costs.
Sexually transmitted infections (STIs) can impact individuals of any demographic. The most common pathogens causing STIs are Chlamydia trachomatis, Neisseria gonorrhea and Trichomonas vaginalis; these can be treated with specific antibiotics.
OBJECTIVE
To compare the GeneXpert CT/NG test-and-treat algorithm to the syndromic approach algorithm and their impact on antibiotic prescription for gonorrhoea and chlamydia STIs.
DESIGN
A retrospective observational study on women aged ≥18 years who accessed the Médecins Sans Frontières Day Care Centre in Athens with complaints related to urogenital infections between January 2021 and March 2022. Women with abnormal vaginal discharge, excluding clinically diagnosed candidiasis, were eligible for Xpert CT/NG testing.
RESULTS
Of the 450 women who accessed care, 84 were eligible for Xpert CT/NG testing, and only one was positive for chlamydia, therefore resulting in saving 81 doses of ceftriaxone and azithromycin, and 19 doses of metronidazole. The cost of Xpert CT/NG testing, including treatment was €4,606.37, while full antibiotic treatment would have costed €536.76.
CONCLUSION
The overall cost of the Xpert CT/NG test-and-treat algorithm was higher than the syndromic approach. However, quality of care should be weighed against the potential benefits of testing and syndromic treatment to determine the best option for each patient; we therefore advocate for decreasing the costs.
Journal Article > ResearchFull Text
Public Health Action. 2023 August 1; Volume 13 (Issue 2(Suppl1)); 7-12.; DOI:10.5588/pha.23.0005
Ditondo P, Luemba A, Chuy RI, Mucinya G, Ade S
Public Health Action. 2023 August 1; Volume 13 (Issue 2(Suppl1)); 7-12.; DOI:10.5588/pha.23.0005
CONTEXTE
Médecins Sans Frontières Belgique a mis en place des diagnostics au point de service (DPS) pour le dépistage précoce d’un VIH avancé, et en présence de celle-ci, d’une TB et d’une cryptococcose, dans six centres de santé (Kasai, St Ambroise, St Joseph, Libondi, Lisanga et Kimia) à Kinshasa, République Démocratique du Congo (RDC).
OBJECTIF
Documenter leur contribution dans le diagnostic de ces affections.
MÉTHODE
Ceci est une étude transversale rétrospective sur des adolescents et adultes VIH-positif, admis avec suspicion d’un VIH avancé. Une comparaison 2 ans avant et 2 ans après installation des DPS a été réalisée.
RÉSULTATS
Au total, 745 et 887 patients étaient retenus respectivement avant et après l’installation des DPS. L’âge moyen était de 39,7 ans (déviation standard [DS] 12,04); 66% (n = 1 077) étaient des femmes. Les patients avec CD4 dosés étaient passés de 40,3% (n = 300) à 64,4% (n = 573) (P < 0,001). Après l’installation des DPS, ils variaient entre 47,8% (Lisanga) et 97,1% (Kasai). La proportion d’infection à VIH avancé était comparable (n = 158, 52,7% vs. n = 288, 50,3%; P = 0,779). Chez les patients avec un VIH avancé, la TB était dépistée chez 28,5% (n = 82), dont 41,5% (n = 34) de confirmation; la cryptococcose était dépistée chez 24,7% (n = 71), dont 9,9% (n = 7) de confirmation. Des disparités entre les centres étaient observés.
CONCLUSION
Les DPS ont augmenté l’accès des patients au dosage des CD4 et au diagnostic d’un VIH avancé dans les six centres dans la RDC. Cependant des actions sont requises pour améliorer cette performance, y compris le dépistage de la TB et de la cryptococcose.
Médecins Sans Frontières Belgique a mis en place des diagnostics au point de service (DPS) pour le dépistage précoce d’un VIH avancé, et en présence de celle-ci, d’une TB et d’une cryptococcose, dans six centres de santé (Kasai, St Ambroise, St Joseph, Libondi, Lisanga et Kimia) à Kinshasa, République Démocratique du Congo (RDC).
OBJECTIF
Documenter leur contribution dans le diagnostic de ces affections.
MÉTHODE
Ceci est une étude transversale rétrospective sur des adolescents et adultes VIH-positif, admis avec suspicion d’un VIH avancé. Une comparaison 2 ans avant et 2 ans après installation des DPS a été réalisée.
RÉSULTATS
Au total, 745 et 887 patients étaient retenus respectivement avant et après l’installation des DPS. L’âge moyen était de 39,7 ans (déviation standard [DS] 12,04); 66% (n = 1 077) étaient des femmes. Les patients avec CD4 dosés étaient passés de 40,3% (n = 300) à 64,4% (n = 573) (P < 0,001). Après l’installation des DPS, ils variaient entre 47,8% (Lisanga) et 97,1% (Kasai). La proportion d’infection à VIH avancé était comparable (n = 158, 52,7% vs. n = 288, 50,3%; P = 0,779). Chez les patients avec un VIH avancé, la TB était dépistée chez 28,5% (n = 82), dont 41,5% (n = 34) de confirmation; la cryptococcose était dépistée chez 24,7% (n = 71), dont 9,9% (n = 7) de confirmation. Des disparités entre les centres étaient observés.
CONCLUSION
Les DPS ont augmenté l’accès des patients au dosage des CD4 et au diagnostic d’un VIH avancé dans les six centres dans la RDC. Cependant des actions sont requises pour améliorer cette performance, y compris le dépistage de la TB et de la cryptococcose.
Journal Article > ResearchFull Text
PLOS Glob Public Health. 2023 March 27; Volume 3 (Issue 3); e0001678.; DOI:10.1371/journal.pgph.0001678
Boyce RM, Ndizeye R, Ngelese H, Baguma E, Shem B, et al.
PLOS Glob Public Health. 2023 March 27; Volume 3 (Issue 3); e0001678.; DOI:10.1371/journal.pgph.0001678
Barriers continue to limit access to viral load (VL) monitoring across sub-Saharan Africa adversely impacting control of the HIV epidemic. The objective of this study was to determine whether the systems and processes required to realize the potential of rapid molecular technology are available at a prototypical lower-level (i.e., level III) health center in rural Uganda. In this open-label pilot study, participants underwent parallel VL testing at both the central laboratory (i.e., standard of care) and on-site using the GeneXpert HIV-1 assay. The primary outcome was the number of VL tests completed each clinic day. Secondary outcomes included the number of days from sample collection to receipt of result at clinic and the number of days from sample collection to patient receipt of the result. From August 2020 to July 2021, we enrolled a total of 242 participants. The median number of daily tests performed on the Xpert platform was 4, (IQR = 2–7). Time from sample collection to result was 51 days (IQR = 45–62) for samples sent to the central laboratory and 0 days (IQR = 0–0.25) for the Xpert assay conducted at the health center. However, few participants elected to receive results by one of the expedited options, which contributed to similar time-to-patient between testing approaches (89 versus 84 days, p = 0.07). Implementation of a rapid, near point-of-care VL assay at a lower-level health center in rural Uganda appears feasible, but interventions to promote rapid clinical response and influence patient preferences about result receipt require further study.
Conference Material > Poster
Abdullah N, Ameen T, Albdulwasa'a R, Alkholidy GC, Shoaib M
MSF Paediatric Days 2022. 2022 November 29; DOI:10.57740/ayzy-ej78