Journal Article > ResearchFull Text
Emerg Infect Dis. 2012 January 1; Volume 68 (Issue 1); DOI:10.1111/j.1365-2648.2011.05934.x
Sanchez-Padilla E, Dlamini T, Ascorra A, Rusch-Gerdes S, Tefera ZD, et al.
Emerg Infect Dis. 2012 January 1; Volume 68 (Issue 1); DOI:10.1111/j.1365-2648.2011.05934.x
In Africa, although emergence of multidrug-resistant (MDR) tuberculosis (TB) represents a serious threat in countries severely affected by the HIV epidemic, most countries lack drug-resistant TB data. This finding was particularly true in the Kingdom of Swaziland, which has the world's highest HIV and TB prevalences. Therefore, we conducted a national survey in 2009-2010 to measure prevalence of drug-resistant TB. Of 988 patients screened, 420 new case-patients and 420 previously treated case-patients met the study criteria. Among culture-positive patients, 15.3% new case-patients and 49.5% previously treated case-patients harbored drug-resistant strains. MDR TB prevalence was 7.7% and 33.8% among new case-patients and previously treated case-patients, respectively. HIV infection and past TB treatment were independently associated with MDR TB. The findings assert the need for wide-scale intervention in resource-limited contexts such as Swaziland, where diagnostic and treatment facilities and health personnel are lacking.
Journal Article > ResearchAbstract
Trop Med Int Health. 2012 October 11; Volume 17 (Issue 12); DOI:10.1111/j.1365-3156.2012.03095.x
Mueller YK, Bastard M, Ehounou G, Itama J, Quere M, et al.
Trop Med Int Health. 2012 October 11; Volume 17 (Issue 12); DOI:10.1111/j.1365-3156.2012.03095.x
Objective To assess the effectiveness of blood transfusions in a hospital of north-eastern Democratic Republic of the Congo. Methods Prospective study of children admitted for severe anaemia. During admission, data were collected on clinical condition and haemoglobin levels, before and after blood transfusion. A linear regression model was built to explore factors associated with haemoglobin level after transfusion. Risk factors for mortality were explored through multivariate logistic regression. Results Haemoglobin level (Hb) was below 4 g/dl in 35% (230/657), between 4 and 6 g/dl in 58% (348/657) and at least 6 g/dl in another 6% (43/657) of the transfused children. A transfusion of 15 ml/kg of whole blood increased the Hb from 4.4 to 7.8 g/dl. Haemoglobin level after transfusion was associated with baseline Hb, quantity of delivered blood and history of previous transfusions. Overall case-fatality rate was 5.6% (37/657). Risk factors for deaths were co-morbidities such as chest infection, meningitis or malnutrition, Hb ≥ 6 g/dl, impaired consciousness or jugular venous distention on admission, and provenance. Conclusion Transfusion was a frequent practice, the use of which could clearly have been rationalised. While indications should be restricted, quantities of transfused blood should be adapted to needs.
Journal Article > ResearchFull Text
BMC Infect Dis. 2018 November 14; Volume 18 (Issue 1); DOI:10.1186/s12879-018-3474-1
Mpala Q, Maphalala G, Uribe PAD, de la Tour R, Kalombola S, et al.
BMC Infect Dis. 2018 November 14; Volume 18 (Issue 1); DOI:10.1186/s12879-018-3474-1
Viral load (VL) testing is being scaled up in resource-limited settings. However, not all commercially available VL testing methods have been evaluated under field conditions. This study is one of a few to evaluate the Biocentric platform for VL quantification in routine practice in Sub-Saharan Africa.
Journal Article > ResearchFull Text
J Acquir Immune Defic Syndr. 2019 September 1; Volume 82 (Issue 1); 96-104.; DOI:10.1097/QAI.0000000000002101
Kerschberger B, Ntshalintshali N, Mpala Q, Diaz Uribe PA, Maphalala G, et al.
J Acquir Immune Defic Syndr. 2019 September 1; Volume 82 (Issue 1); 96-104.; DOI:10.1097/QAI.0000000000002101
BACKGROUND
To assess the performance and suitability of dried blood spot (DBS) sampling using filter paper to collect blood for viral load (VL) quantification under routine conditions.
METHODS
We compared performance of DBS VL quantification using the Biocentric method with plasma VL quantification using Roche and Biocentric as reference methods. Adults (≥18 years) were enrolled at 2 health facilities in Eswatini from October 12, 2016 to March 1, 2017. DBS samples were prepared through finger-prick by a phlebotomist (DBS-1), and through the pipetting of whole venous blood by a phlebotomist (DBS-2) and by a laboratory technologist (DBS-3). We calculated the VL-testing completion rate, correlation, and agreement, as well as diagnostic accuracy estimates at the clinical threshold of 1000 copies/mL.
RESULTS
Of 362 patients enrolled, 1066 DBS cards (DBS-1: 347; DBS-2: 359; DBS-3: 360) were tested. Overall, test characteristics were comparable between DBS-sampling methods, irrespective of the reference method. The Pearson correlation coefficients ranged from 0.67 to 0.82 (P < 0.001) for different types of DBS sampling using both reference methods, and the Bland-Altman difference ranged from 0.15 to 0.30 log10 copies/mL. Sensitivity estimates were from 85.3% to 89.2% and specificity estimates were from 94.5% to 98.6%. The positive predictive values were between 87.0% and 96.5% at a prevalence of 30% VL elevations, and negative predictive values were between 93.7% and 95.4%.
CONCLUSIONS
DBS VL quantification using the newly configured Biocentric method can be part of contextualized VL-testing strategies, particularly for remote settings and populations with higher viral failure rates.
To assess the performance and suitability of dried blood spot (DBS) sampling using filter paper to collect blood for viral load (VL) quantification under routine conditions.
METHODS
We compared performance of DBS VL quantification using the Biocentric method with plasma VL quantification using Roche and Biocentric as reference methods. Adults (≥18 years) were enrolled at 2 health facilities in Eswatini from October 12, 2016 to March 1, 2017. DBS samples were prepared through finger-prick by a phlebotomist (DBS-1), and through the pipetting of whole venous blood by a phlebotomist (DBS-2) and by a laboratory technologist (DBS-3). We calculated the VL-testing completion rate, correlation, and agreement, as well as diagnostic accuracy estimates at the clinical threshold of 1000 copies/mL.
RESULTS
Of 362 patients enrolled, 1066 DBS cards (DBS-1: 347; DBS-2: 359; DBS-3: 360) were tested. Overall, test characteristics were comparable between DBS-sampling methods, irrespective of the reference method. The Pearson correlation coefficients ranged from 0.67 to 0.82 (P < 0.001) for different types of DBS sampling using both reference methods, and the Bland-Altman difference ranged from 0.15 to 0.30 log10 copies/mL. Sensitivity estimates were from 85.3% to 89.2% and specificity estimates were from 94.5% to 98.6%. The positive predictive values were between 87.0% and 96.5% at a prevalence of 30% VL elevations, and negative predictive values were between 93.7% and 95.4%.
CONCLUSIONS
DBS VL quantification using the newly configured Biocentric method can be part of contextualized VL-testing strategies, particularly for remote settings and populations with higher viral failure rates.
Conference Material > Abstract
Kerschberger B, Ntshalintshali N, Maphalala G, Aung A, Mamba C, et al.
MSF Scientific Days International 2021: Research. 2021 May 19
INTRODUCTION
Acute HIV infection (AHI) is rarely diagnosed in resource-limited settings. Barriers to diagnosis include the high costs of viral load (VL)-based diagnostic testing algorithms and lack of
availability of reliable point-of-care (POC) tests. We assessed the performance of a new POC test for the detection of AHI in Eswatini, Alere™ HIV-Combo.
METHODS
Adult outpatients testing HIV-negative on Alere™ Determine through finger-prick testing by lay counselors, or with discordant result (Alere™ Determine-positive and Uni-Gold™-negative)
were enrolled at the Nhlangano Health Centre, between March 2019 and March 2020. Participants were then tested with the quantitative Xpert HIV-1 VL assay, used as the gold standard
test for AHI. AHI was defined as a VL result ≥40 copies/mL. Leftover paired venous whole blood and plasma specimens were tested with the lateral flow fourth-generation antibody/p24 POC Alere™ HIV-Combo. Both Xpert and HIV-Combo tests were performed in the laboratory by a laboratory technician. A positive result for AHI using the HIV-Combo test was defined as reactivity on the p24 antigen and/or antibody bars. Diagnostic test characteristics were evaluated for plasma (HIV-Comboplasma) and whole blood (HIV-Combo-wb), as compared with the results of Xpert testing.
ETHICS
This study was approved by the MSF Ethics Review Board and the Eswatini Ethics Committee.
RESULTS
A total of 745 (HIV-Combo-plasma/Xpert) and 429 (HIV-Combowb/ Xpert) paired test results were available. 29/745 (3.9%) and 19/429 (4.4%) were AHI-positive based on the results of Xpert testing. 26/745 (3.5%) were reactive on HIV-Combo-plasma and 16 (3.7%) on HIV-Combo-wb. Most positive test results with HIV-Combo showed reactivity to antibodies only (76.9% HIV-Combo-plasma; 75.0% HIV-Combo-wb), and the remainder to p24 antigen (15.4%, 18.8%) only, or both p24 antigen and antibodies (7.7%, 6.3%). The area under the receiver operating characteristic curve was 0.93 for HIV-Combo-plasma and 0.89 for HIV-Combo-wb. Test sensitivity tended to be slightly higher for HIV-Combo-plasma (86.2%) as compared to HIV-Combo-wb (78.9%), and specificity was high for both tests (≥99.8%). The negative predictive value was above 99.0% for both tests, and positive predictive values were 93.8% for HIV-Combo-wb and 96.2% for HIV-Combo-plasma.
CONCLUSION
Lateral flow POC HIV-Combo testing in this setting was able to diagnose most cases of AHI, in comparison to the gold standard. This test therefore has potential for use in routine settings due to low cost and ease of use. However, further studies are needed to evaluate its performance when used in routine outpatient care settings by lay counselors on finger-prick samples.
CONFLICTS OF INTEREST
None declared.
Acute HIV infection (AHI) is rarely diagnosed in resource-limited settings. Barriers to diagnosis include the high costs of viral load (VL)-based diagnostic testing algorithms and lack of
availability of reliable point-of-care (POC) tests. We assessed the performance of a new POC test for the detection of AHI in Eswatini, Alere™ HIV-Combo.
METHODS
Adult outpatients testing HIV-negative on Alere™ Determine through finger-prick testing by lay counselors, or with discordant result (Alere™ Determine-positive and Uni-Gold™-negative)
were enrolled at the Nhlangano Health Centre, between March 2019 and March 2020. Participants were then tested with the quantitative Xpert HIV-1 VL assay, used as the gold standard
test for AHI. AHI was defined as a VL result ≥40 copies/mL. Leftover paired venous whole blood and plasma specimens were tested with the lateral flow fourth-generation antibody/p24 POC Alere™ HIV-Combo. Both Xpert and HIV-Combo tests were performed in the laboratory by a laboratory technician. A positive result for AHI using the HIV-Combo test was defined as reactivity on the p24 antigen and/or antibody bars. Diagnostic test characteristics were evaluated for plasma (HIV-Comboplasma) and whole blood (HIV-Combo-wb), as compared with the results of Xpert testing.
ETHICS
This study was approved by the MSF Ethics Review Board and the Eswatini Ethics Committee.
RESULTS
A total of 745 (HIV-Combo-plasma/Xpert) and 429 (HIV-Combowb/ Xpert) paired test results were available. 29/745 (3.9%) and 19/429 (4.4%) were AHI-positive based on the results of Xpert testing. 26/745 (3.5%) were reactive on HIV-Combo-plasma and 16 (3.7%) on HIV-Combo-wb. Most positive test results with HIV-Combo showed reactivity to antibodies only (76.9% HIV-Combo-plasma; 75.0% HIV-Combo-wb), and the remainder to p24 antigen (15.4%, 18.8%) only, or both p24 antigen and antibodies (7.7%, 6.3%). The area under the receiver operating characteristic curve was 0.93 for HIV-Combo-plasma and 0.89 for HIV-Combo-wb. Test sensitivity tended to be slightly higher for HIV-Combo-plasma (86.2%) as compared to HIV-Combo-wb (78.9%), and specificity was high for both tests (≥99.8%). The negative predictive value was above 99.0% for both tests, and positive predictive values were 93.8% for HIV-Combo-wb and 96.2% for HIV-Combo-plasma.
CONCLUSION
Lateral flow POC HIV-Combo testing in this setting was able to diagnose most cases of AHI, in comparison to the gold standard. This test therefore has potential for use in routine settings due to low cost and ease of use. However, further studies are needed to evaluate its performance when used in routine outpatient care settings by lay counselors on finger-prick samples.
CONFLICTS OF INTEREST
None declared.
Conference Material > Poster
Kerschberger B, Mpala Q, Aung A, Ntshalintshali N, Mamba C, et al.
MSF Scientific Days International 2021: Research. 2021 May 18
Journal Article > ResearchFull Text
Int J Tuberc Lung Dis. 2015 June 30; Volume 19 (Issue 9); 1078-1083.; DOI:10.5588/ijtld.14.0951
Page AL, Ardizzoni E, Lassovsky M, Kirubi B, Bichkova D, et al.
Int J Tuberc Lung Dis. 2015 June 30; Volume 19 (Issue 9); 1078-1083.; DOI:10.5588/ijtld.14.0951
SETTING
Despite the widespread introduction of Xpert® MTB/RIF in developing countries, reports of its use and value in routine conditions remain limited.
OBJECTIVE
To describe Xpert results in relation to microscopy, treatment initiation, cost and workload under routine conditions at four sites in Cambodia, Georgia, Kenya and Swaziland.
DESIGN
Laboratory and clinical information on presumed TB patients were obtained from routine registers over a period of at least 6 months between March and November 2012.
RESULTS
Among the 6086 presumed TB patients included in the analysis, Xpert testing increased the number of biologically confirmed cases by 15% to 67% compared to microscopy. Up to 12% of the initial Xpert results were inconclusive. Between 56% and 83% of patients were started on treatment based on microscopy and/or Xpert results, with median delays of 1–16 days. Rifampicin resistance was detected in 3–19% of Xpert-positive patients.
CONCLUSION
Despite the additional numbers of cases detected by Xpert compared to microscopy, large proportions of patients are still started on treatment empirically in routine practice. Patient and specimen flow should be optimised to reduce delays in treatment initiation. Simple, non-sputum-based point-of-care tests with high sensitivity are needed to improve TB diagnosis and management.
Despite the widespread introduction of Xpert® MTB/RIF in developing countries, reports of its use and value in routine conditions remain limited.
OBJECTIVE
To describe Xpert results in relation to microscopy, treatment initiation, cost and workload under routine conditions at four sites in Cambodia, Georgia, Kenya and Swaziland.
DESIGN
Laboratory and clinical information on presumed TB patients were obtained from routine registers over a period of at least 6 months between March and November 2012.
RESULTS
Among the 6086 presumed TB patients included in the analysis, Xpert testing increased the number of biologically confirmed cases by 15% to 67% compared to microscopy. Up to 12% of the initial Xpert results were inconclusive. Between 56% and 83% of patients were started on treatment based on microscopy and/or Xpert results, with median delays of 1–16 days. Rifampicin resistance was detected in 3–19% of Xpert-positive patients.
CONCLUSION
Despite the additional numbers of cases detected by Xpert compared to microscopy, large proportions of patients are still started on treatment empirically in routine practice. Patient and specimen flow should be optimised to reduce delays in treatment initiation. Simple, non-sputum-based point-of-care tests with high sensitivity are needed to improve TB diagnosis and management.
Journal Article > ResearchFull Text
Malar J. 2019 December 26; Volume 18 (Issue 1); 443.; DOI:10.1186/s12936-019-3079-1
Coldiron ME, Assao B, Langendorf C, Sayinzoga-Makombe N, Ciglenecki I, et al.
Malar J. 2019 December 26; Volume 18 (Issue 1); 443.; DOI:10.1186/s12936-019-3079-1
BACKGROUND
Rapid diagnostic tests (RDT) for malaria are common, but their performance varies. Tests using histidine-rich protein 2 (HRP2) antigen are most common, and many have high sensitivity. HRP2 tests can remain positive for weeks after treatment, limiting their specificity and usefulness in high-transmission settings. Tests using Plasmodium lactate dehydrogenase (pLDH) have been less widely used but have higher specificity, mostly due to a much shorter time to become negative.
METHODS
A prospective, health centre-based, diagnostic evaluation of two malaria RDTs was performed in rural Niger during the high malaria transmission season (3–28 October, 2017) and during the low transmission season (28 January–31 March, 2018). All children under 5 years of age presenting with fever (axillary temperature > 37.5 °C) or history of fever in the previous 24 h were eligible. Capillary blood was collected by finger prick. The SD Bioline HRP2 (catalog: 05FK50) and the CareStart pLDH(pan) (catalog: RMNM-02571) were performed in parallel, and thick and thin smears were prepared. Microscopy was performed at Epicentre, Maradi, Niger, with external quality control. The target sample size was 279 children with microscopy-confirmed malaria during each transmission season.
RESULTS
In the high season, the sensitivity of both tests was estimated at > 99%, but the specificity of both tests was lower: 58.0% (95% CI 52.1–63.8) for the pLDH test and 57.4% (95% CI 51.5–63.1) for the HRP2 test. The positive predictive value was 66.3% (95% CI 61.1–71.2) for both tests. In the low season, the sensitivity of both tests dropped: 91.0% (95% CI 85.3–95.0) for the pLDH test and 85.8% (95% CI 79.3–90.9) for the HRP2 test. The positive predictive value remained low for both tests in the low season: 60.5% (95% CI 53.9–66.8) for the pLDH test and 61.9% (55.0–68.4) for the HRP2 test. Performance was similar across different production lots, gender, age of the children, and, during the high season, time since the most recent distribution of seasonal malaria chemoprevention.
CONCLUSIONS
The low specificity of the pLDH RDT in this setting was unexpected and is not easily explained. As the pLDH test continues to be introduced into new settings, the questions raised by this study will need to be addressed.
Rapid diagnostic tests (RDT) for malaria are common, but their performance varies. Tests using histidine-rich protein 2 (HRP2) antigen are most common, and many have high sensitivity. HRP2 tests can remain positive for weeks after treatment, limiting their specificity and usefulness in high-transmission settings. Tests using Plasmodium lactate dehydrogenase (pLDH) have been less widely used but have higher specificity, mostly due to a much shorter time to become negative.
METHODS
A prospective, health centre-based, diagnostic evaluation of two malaria RDTs was performed in rural Niger during the high malaria transmission season (3–28 October, 2017) and during the low transmission season (28 January–31 March, 2018). All children under 5 years of age presenting with fever (axillary temperature > 37.5 °C) or history of fever in the previous 24 h were eligible. Capillary blood was collected by finger prick. The SD Bioline HRP2 (catalog: 05FK50) and the CareStart pLDH(pan) (catalog: RMNM-02571) were performed in parallel, and thick and thin smears were prepared. Microscopy was performed at Epicentre, Maradi, Niger, with external quality control. The target sample size was 279 children with microscopy-confirmed malaria during each transmission season.
RESULTS
In the high season, the sensitivity of both tests was estimated at > 99%, but the specificity of both tests was lower: 58.0% (95% CI 52.1–63.8) for the pLDH test and 57.4% (95% CI 51.5–63.1) for the HRP2 test. The positive predictive value was 66.3% (95% CI 61.1–71.2) for both tests. In the low season, the sensitivity of both tests dropped: 91.0% (95% CI 85.3–95.0) for the pLDH test and 85.8% (95% CI 79.3–90.9) for the HRP2 test. The positive predictive value remained low for both tests in the low season: 60.5% (95% CI 53.9–66.8) for the pLDH test and 61.9% (55.0–68.4) for the HRP2 test. Performance was similar across different production lots, gender, age of the children, and, during the high season, time since the most recent distribution of seasonal malaria chemoprevention.
CONCLUSIONS
The low specificity of the pLDH RDT in this setting was unexpected and is not easily explained. As the pLDH test continues to be introduced into new settings, the questions raised by this study will need to be addressed.
Journal Article > ResearchFull Text
BMC Cardiovascular Disorders. 2021 October 9; Volume 21; 486.; DOI:10.1186/s12872-021-02298-7
Vetter B, Beran D, Boulle P, Chua AC, de la Tour R, et al.
BMC Cardiovascular Disorders. 2021 October 9; Volume 21; 486.; DOI:10.1186/s12872-021-02298-7
INTRODUCTION
Multi-parameter diagnostic devices can simplify cardiometabolic disease diagnosis. However, existing devices may not be suitable for use in low-resource settings, where the burden of non-communicable diseases is high. Here we describe the development of a target product profile (TPP) for a point-of-care multi-parameter device for detection of biomarkers for cardiovascular disease and metabolic disorders, including diabetes, in primary care settings in low- and middle-income countries (LMICs).
METHODS
A draft TPP developed by an expert group was reviewed through an online survey and semi-structured expert interviews to identify device characteristics requiring refinement. The draft TPP included 41 characteristics with minimal and optimal requirements; characteristics with an agreement level for either requirement of ≤ 85% in either the survey or among interviewees were further discussed by the expert group and amended as appropriate.
RESULT
Twenty people responded to the online survey and 18 experts participated in the interviews. Twenty-two characteristics had an agreement level of ≤ 85% in either the online survey or interviews. The final TPP defines the device as intended to be used for basic diagnosis and management of cardiometabolic disorders (lipids, glucose, HbA1c, and creatinine) as minimal requirement, and offering an expanded test menu for wider cardiometabolic disease management as optimal requirement. To be suitable, the device should be intended for level 1 healthcare settings or lower, used by minimally trained healthcare workers and allow testing using self-contained cartridges or strips without the need for additional reagents. Throughput should be one sample at a time in a single or multi-analyte cartridge, or optimally enable testing of several samples and analytes in parallel with random access.
CONCLUSIONS
This TPP will inform developers of cardiometabolic multi-parameter devices for LMIC settings, and will support decision makers in the evaluation of existing and future devices.
Multi-parameter diagnostic devices can simplify cardiometabolic disease diagnosis. However, existing devices may not be suitable for use in low-resource settings, where the burden of non-communicable diseases is high. Here we describe the development of a target product profile (TPP) for a point-of-care multi-parameter device for detection of biomarkers for cardiovascular disease and metabolic disorders, including diabetes, in primary care settings in low- and middle-income countries (LMICs).
METHODS
A draft TPP developed by an expert group was reviewed through an online survey and semi-structured expert interviews to identify device characteristics requiring refinement. The draft TPP included 41 characteristics with minimal and optimal requirements; characteristics with an agreement level for either requirement of ≤ 85% in either the survey or among interviewees were further discussed by the expert group and amended as appropriate.
RESULT
Twenty people responded to the online survey and 18 experts participated in the interviews. Twenty-two characteristics had an agreement level of ≤ 85% in either the online survey or interviews. The final TPP defines the device as intended to be used for basic diagnosis and management of cardiometabolic disorders (lipids, glucose, HbA1c, and creatinine) as minimal requirement, and offering an expanded test menu for wider cardiometabolic disease management as optimal requirement. To be suitable, the device should be intended for level 1 healthcare settings or lower, used by minimally trained healthcare workers and allow testing using self-contained cartridges or strips without the need for additional reagents. Throughput should be one sample at a time in a single or multi-analyte cartridge, or optimally enable testing of several samples and analytes in parallel with random access.
CONCLUSIONS
This TPP will inform developers of cardiometabolic multi-parameter devices for LMIC settings, and will support decision makers in the evaluation of existing and future devices.
Journal Article > ResearchFull Text
J Acquir Immune Defic Syndr; JAIDS. 2021 December 15; Volume 88 (Issue 5); 506-517.; DOI:10.1097/QAI.0000000000002794
Kerschberger B, Aung A, Mpala Q, Ntshalintshali N, Mamba C, et al.
J Acquir Immune Defic Syndr; JAIDS. 2021 December 15; Volume 88 (Issue 5); 506-517.; DOI:10.1097/QAI.0000000000002794
BACKGROUND
The lack of acute and early HIV infection (AEHI) diagnosis and care contributes to high HIV incidence in resource-limited settings. We aimed to assess the yield, predict and diagnose AEHI, and describe AEHI care outcomes in a public sector setting in Eswatini.
SETTING
This study was conducted in Nhlangano outpatient department, from March 2019 to March 2020.
METHODS
Adults at risk of AEHI underwent diagnostic testing for AEHI with the quantitative Xpert HIV-1 viral load (VL) assay. AEHI was defined as the detection of HIV-1 VL on Xpert and either a HIV-seronegative/HIV-serodiscordant third-generation antibody-based rapid-diagnostic test (RDT) result. First, the cross-sectional analysis obtained the yield of AEHI and established a predictor risk score (PRS) for the prediction of AEHI using Lasso logistic regression. Second, diagnostic accuracy statistics described the ability of the fourth-generation antibody/p24 antigen-based Alere™HIV-Combo RDT to diagnose AEHI (vs Xpert VL testing). Third, we described AHI care outcomes of AEHI-positive patients using survival analysis.
RESULTS
Of 795 HIV-seronegative/HIV-serodiscordant outpatients recruited, 30 (3.8%, 95%CI 2.6-5.3%) had AEHI. The PRS contained several factors (HIV-serodiscordant RDT, women, feeling at risk of HIV, swollen glands, fatigue) and had a sensitivity and specificity of 83.3% and 65.8% to predict AEHI. The HIV-Combo RDT had a sensitivity and specificity of 86.2% and 99.9% to diagnose AEHI. Of 30 AEHI-positive patients, the 1-month cumulative treatment initiation was 74% (95%CI 57-88%), and the 3-month viral suppression (<1000 copies/mL) was 87% (67-98%).
CONCLUSION
AEHI diagnosis and care appears possible in resource-limited settings.
The lack of acute and early HIV infection (AEHI) diagnosis and care contributes to high HIV incidence in resource-limited settings. We aimed to assess the yield, predict and diagnose AEHI, and describe AEHI care outcomes in a public sector setting in Eswatini.
SETTING
This study was conducted in Nhlangano outpatient department, from March 2019 to March 2020.
METHODS
Adults at risk of AEHI underwent diagnostic testing for AEHI with the quantitative Xpert HIV-1 viral load (VL) assay. AEHI was defined as the detection of HIV-1 VL on Xpert and either a HIV-seronegative/HIV-serodiscordant third-generation antibody-based rapid-diagnostic test (RDT) result. First, the cross-sectional analysis obtained the yield of AEHI and established a predictor risk score (PRS) for the prediction of AEHI using Lasso logistic regression. Second, diagnostic accuracy statistics described the ability of the fourth-generation antibody/p24 antigen-based Alere™HIV-Combo RDT to diagnose AEHI (vs Xpert VL testing). Third, we described AHI care outcomes of AEHI-positive patients using survival analysis.
RESULTS
Of 795 HIV-seronegative/HIV-serodiscordant outpatients recruited, 30 (3.8%, 95%CI 2.6-5.3%) had AEHI. The PRS contained several factors (HIV-serodiscordant RDT, women, feeling at risk of HIV, swollen glands, fatigue) and had a sensitivity and specificity of 83.3% and 65.8% to predict AEHI. The HIV-Combo RDT had a sensitivity and specificity of 86.2% and 99.9% to diagnose AEHI. Of 30 AEHI-positive patients, the 1-month cumulative treatment initiation was 74% (95%CI 57-88%), and the 3-month viral suppression (<1000 copies/mL) was 87% (67-98%).
CONCLUSION
AEHI diagnosis and care appears possible in resource-limited settings.