HIV Rapid Diagnostic Tests Research Articles

Low-level of HIV-1 Seroreversion among People on Successful Antiretroviral Therapy in Cameroon: Implications for Clinical Monitoring in Resource-limited Settings

Background: Initiating early HIV treatment results to sustained viral suppression, reduced viral reservoirs and prompt immune reconstitution that may lead to HIV seronegativity (seroreversion). Seroreversion can be misinterpreted, leading to inappropriate clinical considerations. We thus sought to determine the HIV seroreversion among antiretroviral therapy (ART)-experienced Cameroonians. Method: A laboratory-based cross-sectional study was conducted among ART-experienced individuals with undetectable plasma viral load (less than 40 copies/mL) in 2019 at the Chantal BIYA International Reference Centre in Yaounde-Cameroon. On all blood samples, HIV antibody testing was performed using two rapid diagnostic tests (RDTs), followed by enzyme-linked immunosorbent assay. On non-reactive samples, proviral DNA was tested on on dried blood spots (DBS) specimens. Results: Of the 546 participants on ART (median ART duration : 5 years) and all experiencing a successful ART (VL<40 copies/ml), only 01% (5/546) had shown HIV negative results. Of these five non-reactive cases, only one case (0.18%) was non-reactive to HIV RDTs but reactive to ELISA, and four cases (0.72%) were non-reactive to both RDTs and ELISA. These four samples were also negative for HIV proviral DNA, indicating potential absence of infection or an optimal control of viral replication. Conclusion: Seroreversion of HIV-1 infection is possible but may occur rarely among HIV-infected Cameroonians who are on successful ART. The few cases of HIV negativity on serology and DBS-PCR (proviral DNA) underscores the need for deeper HIV proviral DNA testing (on PBMC) to guide either continuous ART, detect possible functional cure, or events of HIV misdiagnosis in an era of declining prevalence.

Assessing secular trends in HIV rapid diagnostic test uptake and positivity in Northeast Iran, a country in MENA region; ingredients for target-specific prevention policies

BackgroundIran is amongst the first three countries in Middle East and North Africa (MENA) region where two-thirds of region’s new HIV infections are reported. HIV testing at the population level is key to interrupting the HIV transmission chain. The current study aimed to evaluate the history of HIV rapid diagnostic testing (HIV-RDT) and its correlates in northeast Iran.MethodsIn this cross-sectional study, de-identified records of HIV-RDTs were extracted by the census method from the electronic health information system of 122 testing facilities between 2017 and 2021. Descriptive, bivariate, and multiple logistic regression analyses were performed to identify the factors associated with HIV-RDT uptake and risks and drivers of HIV-RDT positivity, separately among men and women.ResultsConducting 66,548 HIV-RDTs among clients with a mean age of 30.31 years, 63% female, 75.2% married, and 78.5% with high school education or below, yielded 312 (0.47%) positive results. Test uptake was comparatively low among men and the unmarried sub-population. Prenatal care and high-risk heterosexual intercourse were the most frequent reasons for taking HIV-RDT among women and men, respectively (76% and 61.2%). High-risk heterosexual contact, tattooing, mother-to-child transmission (MTCT), having a partner at risk of HIV infection, and injecting drugs were test seekers’ most reported transmission routes. One-third of the newly-infected female clients were identified through prenatal testing. Multivariate analysis revealed older age at the time of testing (Adjusted Odd Ratio (AOR) = 1.03), divorce (AOR = 2.10), widowhood (AOR = 4.33), education level of secondary school (AOR = 4.67), and unemployment (AOR = 3.20) as significant demographic predictors of positive HIV-RDT (P-value < 0.05). However, clients’ nationality, testing history, duration of HIV exposure, and reported reasons for taking HIV-RDT were not associated with the test result (P-value > 0.05).ConclusionInnovative strategies are required to scale up test uptake and positive yields among the key population in the region. The current evidence strongly suggests implementing gender-targeted strategies, according to the differences in demographic and behavioral risk between men and women.

Development of an approach to monitor the manufacturing consistency of HIV rapid diagnostic tests: Panel qualification and potential impact on country programs.

Although regulatory bodies have standards that manufacturers of rapid diagnostic tests (RDTs) must meet for market approval, RDTs have no specific sampling and testing standards to monitor ongoing lot production, unlike pharmaceuticals and certain devices. With the importance of accurate diagnosis for improved health outcomes, independent quality assurance testing is key to ensuring the availability of high-quality RDTs, particularly in low-resource settings. This work develops an approach for HIV RDT lot testing, involving qualification of specimens to enable testing across various RDTs (namely Determine HIV-1/2, OraQuick HIV-1/2, Bioline HIV-1/2 3.0, UniGold HIV, and HIV Ag/Ab Combo). A sampling plan and acceptance criteria were developed per lot (approximating sensitivity and specificity) based on ISO 2859-1: 1999, using the test line response to a qualified panel (disease-positive and negative specimens) as the attribute. Based on general performance of HIV RDTs, an average % defective tests allowed per lot (acceptance quality limit) of 0.65% within ISO 2859-1: 1999 was selected, where RDTs are tested with 80 positives (accept 1 / reject 2 defective results) and 80 negatives (accept 1 / reject 2 defective results) per lot. Panel qualification was conducted with 83 positive and 84 negative serum specimens to select specimens that consistently provided expected results when tested in quadruplicate with three lots per product. While all products yielded consistent results with at least 80 negative specimens, only 4 products did the same for positive specimens. With this approach, each of these 4 RDT products can be tested with the qualified 80-positive specimen panel, requiring the other product to be tested with 20 specimens in quadruplicate. Additionally, this approach was adapted to evaluate HIV antibody/antigen combination tests with Ag panel qualification using p24 samples. While panels were qualified to monitor ongoing lot consistency of HIV RDTs, this approach could be mimicked with other types of diagnostics for monitoring manufacturing consistency, field investigation, small-scale stability checks, and proficiency testing.

Barriers and facilitators to HIV and syphilis rapid diagnostic testing in antenatal care settings in low-income and middle-income countries: a systematic review

BackgroundTesting and treatment during pregnancy is a well-established and cost-effective prevention strategy, which relies largely on use of rapid diagnostic tests (RDTs). Yet, in many low-income and-middle-income countries, the uptake...

Evaluation of accuracy and performance of self-reported HIV and antiretroviral therapy status in the Nigeria AIDS Indicator and Impact Survey (2018).

BackgroundData on awareness of HIV status among people living with HIV (PLHIV) are critical to estimating progress toward epidemic control. To ascertain the accuracy of self-reported HIV status and antiretroviral drug (ARV) use in the Nigeria HIV/AIDS Indicator and Impact Survey (NAIIS), we compared self-reported HIV status with HIV rapid diagnostic test (RDT) results and self-reported ARV use with detectable blood ARV levels.MethodsOn the basis of responses and test results, participants were categorized by HIV status and ARV use. Self-reported HIV status and ARV use performance characteristics were determined by estimating sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Proportions and other analyses were weighted to account for complex survey design.ResultsDuring NAIIS, 186,405 participants consented for interview out of which 58,646 reported knowing their HIV status. Of the 959 (weighted, 1.5%) who self-reported being HIV-positive, 849 (92.1%) tested HIV positive and 64 (7.9%) tested HIV negative via RDT and polymerase chain reaction test for discordant positive results. Of the 849 who tested HIV positive, 743 (89.8%) reported using ARV and 72 (10.2%) reported not using ARV. Of 57,687 who self-reported being HIV negative, 686 (1.2%) tested HIV positive via RDT, with ARV biomarkers detected among 195 (25.1%). ARV was detected among 94.5% of those who self-reported using ARV and among 42.0% of those who self-reported not using ARV. Overall, self-reported HIV status had sensitivity of 52.7% (95% confidence interval [CI]: 49.4%–56.0%) with specificity of 99.9% (95% CI: 99.8%–99.9%). Self-reported ARV use had sensitivity of 95.2% (95% CI: 93.6%–96.7%) and specificity of 54.5% (95% CI: 48.8%–70.7%).ConclusionsSelf-reported HIV status and ARV use screening tests were found to be low-validity measures during NAIIS. Laboratory tests to confirm self-reported information may be necessary to determine accurate HIV and clinical status for HIV studies in Nigeria.

Cost-effectiveness of implementing HIV and HIV/syphilis dual testing among key populations in Viet Nam: a modelling analysis

ObjectivesKey populations, including sex workers, men who have sex with men, and people who inject drugs, have a high risk of HIV and sexually transmitted infections. We assessed the health...

Vaccine-Induced Seroreactivity Impacts the Accuracy of HIV Testing Algorithms in Sub-Saharan Africa: An Exploratory Study.

The detection of vaccine-induced HIV antibody responses by rapid diagnostic tests (RDTs) may confound the interpretation of HIV testing results. We assessed the impact of vaccine-induced seroreactivity (VISR) on the diagnosis of HIV in sub-Saharan Africa. Samples collected from healthy participants of HIVIS and TaMoVac HIV vaccine trials after the final vaccination were analyzed for VISR using HIV testing algorithms used in Mozambique and Tanzania that employ two sequential RDTs. The samples were also tested for VISR using Enzygnost HIV Integral 4 ELISA and HIV western blot assays. Antibody titers to subtype C gp140 were determined using an in-house enzyme-linked immunosorbent assay (ELISA). The frequency of VISR was 93.4% (128/137) by Enzygnost HIV Integral 4 ELISA, and 66.4% (91/137) by western blot assay (WHO interpretation). The proportion of vaccine recipients that would have been misdiagnosed as HIV-positive in Mozambique was half of that in Tanzania: 26.3% (36/137) and 54.0% (74/137), respectively, p < 0.0001. In conclusion, the HIV RDTs and algorithms assessed here will potentially misclassify a large proportion of the HIV vaccine recipients if no other test is used. Increased efforts are needed to develop differential serological or molecular tools for use at the point of care.

Implementation of tuberculosis and cryptococcal meningitis rapid diagnostic tests amongst patients with advanced HIV at Kamuzu Central Hospital, Malawi, 2016\u20132017

BackgroundCryptococcal meningitis (CM) and tuberculosis (TB) remain leading causes of hospitalization and death amongst people living with HIV, particularly those with advanced HIV disease. In hospitalized patients, prompt diagnosis of these diseases may improve patient outcomes. The advanced HIV rapid diagnostic tests such as determine TB urine lipoarabinomannan lateral flow assay (urine LAM), urine X-pert MTB/RIF assay (urine X-pert), and serum/blood cryptococcal antigen test (serum CrAg) are recommended but frequently not available in many resource-limited settings. We describe our experience providing these tests in a routine hospital setting.MethodFrom 1 August 2016 to 31 January 2017, a prospective cohort study to diagnose TB and Cryptococcal meningitis using point of care tests was conducted in the medical wards at Kamuzu Central Hospital, in Lilongwe, Malawi. The tests offered were PIMA CD4 cell count, serum CrAg, urine LAM, and urine X-pert. The testing was integrated into an existing HIV/TB treatment room on the wards and performed close to admission time. Patients were followed until discharge or death in the ward.ResultsWe included 438 HIV-positive patients; 76% had a previously known HIV diagnosis (87% already on ART). We measured CD4 count in 365/438 (83%), serum CrAg in 301/438 (69%), urine LAM in 363/438 (83%), and urine X-pert in 292/438 (67%). The median CD4 count was 144 cells/ml (IQR 46–307). Serum CrAg positivity rate was 23 /301 (8%) and CM was confirmed by CSF Crag in 13/23 (56%). The majority of CM patients 9/13 (69%) started antifungal therapy within two days of diagnosis. Urine LAM and urine X-pert positivity rates were 81/363(22%) and (14/292 (5%) respectively. The positivity rate of urine LAM was higher in patients with low CD4 cell counts (< 100 cells/ml) and low BMI (< 18.5). Most patients with positive urine LAM started TB treatment on the same day. Despite the early diagnosis and treatment of TB and CM, the inpatient mortality was high; 30% and 25% respectively.ConclusionAlthough advanced HIV rapid diagnostic tests are recommended, one key challenge in implementation is the limited trained personnel administering the tests. Despite the effective use of the point of care tests in the clinical care of hospitalized TB and CM patients, mortality among these patients remained unacceptably high. Henceforth we need to train other cadres apart from nurses, clinicians, and laboratory technicians to conduct the tests. There is an urgent need to identify and modify other risks of death from TB and CM.Trial registration: Malawi National Health Science Research committee: Protocol # 1144. Registered 2 July 2014 and University Of North Carolina IRB #: UNCPM 21412, approved 13th October 2014.

Sensitivity and specificity of OraQuick® HIV self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural Zambia

BackgroundHIV self-testing (HIVST) has the potential to increase coverage of HIV testing, but concerns exist about intended users’ ability to correctly perform and interpret tests, especially in poor communities with low literacy rates. We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection.MethodsParticipants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors.ResultsInitial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly.Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2–96.7) and 99.7% specific (95%CI: 99.3–99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70–91.3; specificity 99.7%, 95%CI: 99.4–99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7–96.1%; specificity 100% (95%CI: 99.8–100%) had considerably lower sensitivity.ConclusionsSelf-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. However, sensitivity of the self-test was reduced compared to a laboratory reference standard, as was the national RDT algorithm. In-person demonstration, along with the written manufacturer instructions, was needed to obtain accurate results. Programmes introducing self-care diagnostics should pilot and optimise support materials to ensure they are appropriately adapted to context.

English

The broad genetic diversity of HIV requires regular reassessment of adopted HIV diagnostic tests. The objective of this study was to reassess the performances of Determine&reg; HIV 1/2 and Uni-gold&reg; HIV1/2, 2 HIV rapid diagnostic tests of the national algorithm, adopted since 2005 in Central African Republic. A reference prospective panel of 150 plasma samples were tested in duplicate with Determine&reg; HIV 1/2 and Uni-gold&reg; HIV, according to reference serological immune-enzymatic method. Analytical and virological characteristics were calculated. Sensitivity, specificity, positive and negative predictive values (PPV, NPV) of Determine&reg; HIV 1/2 were 100%, as well as the specificity and NPV of Uni-gold&reg; HIV 1/2. Uni-gold&reg; HIV 1/2 sensitivity and PPV were 96 and 92%, respectively. The Cohen k coefficient was close to 1 for the 2 tests, 1 for Determine&reg; HIV 1/2 and 0.97 for Uni-gold&reg; HIV 1/2. Except for the sensitivity of Uni-gold&reg; HIV 1/2, the performances of 2 tests were acceptable and in perfect agreement with the reference tests. These results require a revision of the algorithm. In addition, an exploration in molecular biology is indicated to determine the subtypes of the HIV strains of the 4 samples that tested false negative with Uni-gold&reg; HIV 1/2. &nbsp; Key words: HIV, rapid diagnosis test, sensitivity, specificity, Africa, Central African Republic.

Usability and Clinical Performance Characteristics of the Asante HIV1/2 Test by Trained Users in Two African Sites

HIV self-testing (HIVST) devices are acknowledged as having the potential to enable the acceleration of HIV diagnosis and linkage to care. How efficiently professional and trained users engaged with the Asante HIV-1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portland, OR, USA), and the accuracy of the device in comparison to other HIV rapid diagnostic tests (RDT), was assessed to be able to guide the development and adoption of the device in Senegal and South Africa. Using convenience sampling, potential participants were recruited from catchment areas where HIV was prevalent. Trained users performed an HIV test on participants using an Oral HIVST. The professional user’s interpretation of results was then measured against the results of various other RDTs. The South African study had 1652 participants and the Senegalese, 500. Most of the participants in each study were 18–35 years old. Senegal had a higher number of females (346/500, 69.2%) compared to South Africa (699/1662, 42.1%). Asante displayed very high sensitivity and specificity when tested against other devices. In the final enzyme-linked immunosorbent assay (ELISA) comparison, in South Africa, the sensitivity: specificity was 99.1:99.9% and in Senegal, 98.4:100.0%. Senegal further identified 53/63 (84.1%) with HIV-1, 8/63 (12.7) with HIV-2 and 2/63 (3.2%) with HIV-1/2 co-infections. Professional or trained users’ interpretations of Asante results correlated strongly to results when using various RDTs, the ELISA assay and Western blot tests, making it a dependable HIV testing instrument.

Reconfirming HIV serostatus in three West African Military ART clinics.

HIV rapid diagnostic test (RDT) algorithms have been successfully employed worldwide to accelerate critically important HIV testing. Deviations from the algorithm and processing errors have been associated with inaccurate algorithm results. Positive RDT algorithm results should be confirmed prior to HIV clinic enrollment, but compliance varies. We sought to retest HIV status of patients in three West African military HIV clinics. Military HIV clinics in Lome, Togo; Freetown, Sierra Leone; and Monrovia, Liberia METHODS: Patients coming for routine HIV clinic visits were approached for enrollment. Consenting participants completed a 15-minute questionnaire and provided blood samples for both national and WHO-recommended HIV RDT algorithms, and HIV ELISA (plus HIV PCR if HIV ELISA negative). In total, 817 participants provided data: 374 in Togo, 360 in Sierra Leone, and 83 in Liberia. One participant from Liberia was HIV-negative (although follow-up testing was positive). Two of 807 participants on antiretroviral treatment (ART) had inconclusive algorithms, while 2 of 10 participants not on ART had algorithms, for 4 total based on the WHO-approved algorithm. Using the national algorithms, only 3 were inconclusive. A substantial proportion of the cohort had taken ART for over 6 years (25-46%, depending on the site). HIV RDT retesting in three military HIV clinics did not uncover significant numbers of misclassified HIV patients. There was no significant difference between national and WHO-recommended RDT algorithms, although the study was underpowered to detect a difference. Antiretroviral treatment was not associated with increased rates of inconclusive RDT algorithm results.

Sleeping Sickness: A Cause of False Positive HIV Rapid Diagnostic Tests

RésuméL'approche des mécanismes liés aux résultats faussement positifs des tests de diagnostic rapide (TDR) du VIH chez les patients atteints de la trypanosomose humaine africaine (THA) ou maladie du sommeil contribuera à améliorer la précision du dépistage de l'infection par le VIH, dans les zones endémiques pour la THA.Nous présentons le cas d'une patiente du Congo, prise en charge pour une méningoencéphalite opportuniste d'un sida lors de son admission sur la base d'un TDR VIH qui s'est ensuite révélé faussement positif, et dont le diagnostic était celui de maladie du sommeil. Une étude de cohorte rétrospective réalisée ultérieurement chez des patients atteints de THA, montre que la plupart des TDR VIH positifs avant traitement sont des faux positifs et que la moitié d'entre eux ont disparu à la fin du traitement, ce qui suggère une clearance rapide d'anticorps en réaction croisée avec le parasite.Une part importante des TDR VIH faussement positifs disparaît avant la fin du traitement trypanocide. Là où les tests sérologiques Elisa VIH ne sont pas rapidement accessibles, le renouvellement du TDR VIH en fin de traitement de la THA permet d'identifier environ la moitié des TDR VIH faussement positifs.

Quality of Malaria and HIV Rapid Diagnostic Test kits (RDTs) in health facilities and medicines outlets in the Greater Accra Region of Ghana

Background: Questions remain on the quality of malaria and HIV Rapid Diagnostic Test kits (RDTs) stocked and used in health facilities in Ghana. The Food and Drugs Authority (FDA) in Ghana is mandated to regulate RDTs for quality. By this, all RDTs must be registered, and each brand given a unique registration number. This study aimed to assess the quality of malaria and HIV RDTs in health facilities in the Greater Accra Region of Ghana, using FDA standards. Method: Data was obtained using structured questionnaire from 400 facilities in three districts in the Greater Accra region. A multi-stage sampling procedure was used to select the health facilities including retail medicine outlets. Information on the registration status of the RDTs and conditions under which they were stored were gathered. RDTs kept in air conditioned or well-ventilated rooms were considered as being stored under good condition. RDTs, registered by the FDA and appropriately stored were considered to be of good quality. Data was coded, stored, and analyzed using STATA version 15. Results: About 17% of the malaria RDTs stocked in the pharmacies were unregistered, 85.7% in hospitals were registered. Also, 83.3% of HIV RDTs in the Policlinics were registered. Registration status of the RDTs were associated with the districts in which the health facilities were located (p = 0.006). The RDTs were generally stored under good conditions (99.5%). Over forty percent (41.9%) of user practitioners interviewed rated the quality of the malaria RDTs as good and 59.2% rated HIV RDTs as very good. Conclusion: Though there were some unregistered RDTs whose quality cannot be ascertained, the quality of malaria and HIV RDTs in the facilities assessed were rated as good and likely to produce good results for malaria and HIV case detection.

Self-testing for HIV, HBV, and HCV using finger-stick whole-blood multiplex immunochromatographic rapid test: A pilot feasibility study in sub-Saharan Africa.

BackgroundThe burden of HIV, HBV, and HCV infections remains disproportionately high in sub-Saharan Africa, with high rates of co-infections. Multiplex rapid diagnostic tests for HIV, HBV and HCV serological testing with high analytical performances may improve the “cascade of screening” and quite possibly the linkage-to-care with reduced cost. Based on our previous field experience of HIV self-testing, we herein aimed at evaluating the practicability and acceptability of a prototype finger-stick whole-blood Triplex HIV/HCV/HBsAg self-test as a simultaneous serological screening tool for HIV, HBV, and HCV in the Democratic Republic of the Congo (DRC).MethodsA cross-sectional multicentric study consisting of face-to-face, paper-based, and semi-structured questionnaires with a home-based and facility-based recruitment of untrained adult volunteers at risk of HIV, HBV, and HCV infections recruited from the general public was conducted in 2020 in urban and rural areas in the DRC. The practicability of the Triplex self-test was assessed by 3 substudies on the observation of self-test manipulation including the understanding of the instructions for use (IFU), on the interpretation of Triplex self-test results and on its acceptability.ResultsA total of 251 volunteers (mean age, 28 years; range, 18–49; 154 males) were included, from urban [160 (63.7%)] and rural [91 (36.3%)] areas. Overall, 242 (96.4%) participants performed the Triplex self-test and succeeded in obtaining a valid test result with an overall usability index of 89.2%. The correct use of the Triplex self-test was higher in urban areas than rural areas (51.2% versus 16.5%; aOR: 6.9). The use of video IFU in addition to paper-based IFU increased the correct manipulation and interpretation of the Triplex self-test. A total of 197 (78.5%) participants correctly interpreted the Triplex self-test results, whereas 54 (21.5%) misinterpreted their results, mainly the positive test results harboring low-intensity band (30/251; 12.0%), and preferentially the HBsAg band (12/44; 27.3%). The rates of acceptability of reuse, distribution of the Triplex self-test to third parties (partner, friend, or family member), linkage to the health care facility for confirmation of results and treatment, and confidence in the self-test results were very high, especially among participants from urban areas.ConclusionsThis pilot study shows evidence for the first time in sub-Saharan Africa on good practicability and high acceptability of a prototype Triplex HIV/HCV/HBsAg self-test for simultaneous diagnosis of three highly prevalent chronic viral infections, providing the rational basis of using self-test harboring four bands of interest, i.e. the control, HIV, HCV, and HBsAg bands. The relatively frequent misinterpretation of the Triplex self-test points however the necessity to improve the delivery of this prototype Triplex self-test probably in a supervised setting. Finally, these observations lay the foundations for the potential large-scale use of the Triplex self-test in populations living in sub-Saharan Africa at high risk for HIV, HBV, and HCV infections.

The role of Poct in delivery of standard care in war ridden and terrorized regions, in Nigeria

Background: Thousands of Nigerians have either been displaced or killed owing to the violent conflict that has plagued the country over the years. This year alone, more than 70,000 people have been displaced from their homes from Borno and Yobe states alone. These people have medical needs. This need may be Combat or Non-combat related. However, rapid testing, early diagnosis and prompt treatment is a needed advantage they all have in common. This is where Point-of-care-testing (POCT) comes in. The aim of this paper is to discuss the role of POCT in delivery of standard care in war ridden and terrorized regions in Nigeria.Discussion: POCT can be implemented to improve care of Medical, Infectious, Geriatric, Obstetric and Pediatric cases. Due to endemicity in our region, other critical tests that can be done to ensure early diagnosis and prompt treatment are Malaria, Hepatitis, HIV and Typhoid rapid diagnostic tests. Some major limitations to be faced antagonizing improved POCT in these regions are availability, Accessibility, Skilled Man power.Conclusion: Increased POCT can improve rapid testing, early diagnosis and prompt treatments in these violent conflicts ridden regions in Nigeria. However, poor availability, accessibility and man-power are a major limitation.

HIV Prevalence among Meical Inward Patients in the National Hospital of Sri Lanka (NHSL) with the Assessment of Patient Acceptance, the Feasibility and Challenges of the Hospital Based Rapid HIV Diagnostic Test

<strong>Introduction: </strong>Hospital based HIV Rapid Diagnostic Testing (RDT) was introduced in 2018, following programmatic decision. However, being the province with the highest HIV prevalence in the country, the number of hospital based rapid testing carried out in Western province was not impressive, leading to missed opportunities and late diagnosis. Therefore, RDT was re-implemented in selected medical wards of NHSL. <strong> </strong> <strong>Objective: </strong>To assess the case detection rate, the feasibility and challenges of the rapid HIV testing services among inpatients of medical wards of NHSL. <strong> </strong> <strong>Method: </strong>A descriptive demonstration study, carried out among consecutive 3,395 new admissions to selected medical wards of the NHSL within three months period. HIV status was tested on finger prick blood, using FDA and WHO approved 4th generation HIV RDT (with 100% sensitivity, 99.7% specificity) following informed consent. Patient information were extracted from bed head tickets. Focus Group Discussions (FGD) were carried out with the relevant hospital staff to assess the challenges. Confidentiality of patients ensured by training all the health care workers involved in RDT and followed up of the positive test results, according to the national guidelines <strong> </strong> <strong>Results: </strong>Among the 3395 participants, eight (8) were found to be positive, with the HIV prevalence of 0.23 %. The patient acceptance rate was 96%. Out of the positives, majority were males (n=6) and married (n=5) and half of them were from the Colombo district. Only two (25 %) had AIDS defining symptoms while the majority (n=5) had baseline CD4 count less than 200 cells/μl . Work overload, consent taking, lack of confidence in post-test HIV counselling were identified as major areas of concern. <strong> </strong> <strong>Conclusions: </strong>Hospital-based HIV rapid testing is one of the high yielding programmatic strategies implemented in the country so far. The positivity rate of the study sample was 0.23% which is higher than the HIV positivity rate reported through different testing strategies including the general public (0.03%), and STD samples (0.1%). Further, beating up the challenge of missed opportunities and late diagnosis was highlighted. Therefore, addressing the identified barriers through policy and administrative support and further scaling up of hospital-based HIV testing is highly recommended.

The availability, use and disposal of malaria and HIV rapid diagnostic test kits in health facilities in the greater Accra region of Ghana

Background: The Malaria and HIV rapid diagnostic tests (RDTs) are some of the commonest tests that are used in Ghana to support malaria and HIV management/care respectively. When these devices are used, they are categorized as potentially infectious. This paper aims to highlight the availability and management of used malaria and HIV RDTs in various healthcare facilities and by health service providers in the greater Accra region of Ghana.Methods: Data was obtained from 400 health facilities including hospitals, clinics, health centres, and pharmacies and over the counter medicine seller’s shops using purposive sampling technique with the aid of structured questionnaires and observation of practices.Results: Seventy percent of the facilities (n=280) used only malaria RDTs, 29% (n=116) used both malaria and HIV RDTs and 1% (n=4) reported using HIV RDTs only. 81.7% (n=326) which formed the majority used less than 10 RDTs daily. There was poor waste segregation, storage, transportation, treatment and disposal of waste. Facilities that had some sort of on-site treatment of waste used single chambered incinerators.Conclusions: Each of the categories of health facilities had a common practice of poor hazardous waste management. We therefore recommend that there should be enhancement of education and training of practitioners in the health facilities and the general public on the optimal use of the RDTs and disposal or the management of healthcare waste in general. The environmental protection agency and ministry of health should collaborate and enforce all the regulations on healthcare waste management in the various facilities.

Cost-effectiveness of dual maternal HIV and syphilis testing strategies in high and low HIV prevalence countries: a modelling study

SummaryBackgroundDual HIV and syphilis testing might help to prevent mother-to-child transmission (MTCT) of HIV and syphilis through increased case detection and treatment. We aimed to model and assess the cost-effectiveness of dual testing during antenatal care in four countries with varying HIV and syphilis prevalence.MethodsIn this modelling study, we developed Markov models of HIV and syphilis in pregnant women to estimate costs and infant health outcomes of maternal testing at the first antenatal care visit with individual HIV and syphilis tests (base case) and at the first antenatal care visit with a dual rapid diagnostic test (scenario one). We additionally evaluated retesting during late antenatal care and at delivery with either individual tests (scenario two) or a dual rapid diagnosis test (scenario three). We modelled four countries: South Africa, Kenya, Colombia, and Ukraine. Strategies with an incremental cost-effectiveness ratio (ICER) less than the country-specific cost-effectiveness threshold (US$500 in Kenya, $750 in South Africa, $3000 in Colombia, and $1000 in Ukraine) per disability-adjusted life-year averted were considered cost-effective.FindingsRoutinely offering testing at the first antenatal care visit with a dual rapid diagnosis test was cost-saving compared with the base case in all four countries (ICER: –$26 in Kenya,–$559 in South Africa, –$844 in Colombia, and –$454 in Ukraine). Retesting during late antenatal care with a dual rapid diagnostic test (scenario three) was cost-effective compared with scenario one in all four countries (ICER: $270 in Kenya, $260 in South Africa, $2207 in Colombia, and $205 in Ukraine).InterpretationIncorporating dual rapid diagnostic tests in antenatal care can be cost-saving across countries with varying HIV prevalence. Countries should consider incorporating dual HIV and syphilis rapid diagnostic tests as the first test in antenatal care to support efforts to eliminate MTCT of HIV and syphilis.FundingWHO, US Agency for International Development, and the Bill & Melinda Gates Foundation.

Does peer-navigated linkage to care work? A cross-sectional study of active linkage to care within an integrated non-communicable disease-HIV testing centre for adults in Soweto, South Africa.

IntroductionSouth Africa is the HIV epidemic epicentre; however, non-communicable diseases (NCDs) will be the most common cause of death by 2030. To improve identification and initiation of care for HIV and NCDs, we assessed proportion of clients referred and linked to care (LTC) for abnormal/positive screening results and time to LTC and treatment initiation from a HIV Testing Services (HTS) Centre before and after integrated testing for NCDs with optional peer-navigated linkage to care.Materials and methodsThis two-phase prospective study was conducted at an adult HTS Centre in Soweto, South Africa. Phase 1 (February-June 2018) utilised standard of care (SOC) HTS services (blood pressure [BP], HIV rapid diagnostic testing (RDT), sexually transmitted infections [STI]/Tuberculosis [TB] symptom screening) with passive referral for abnormal/positive results. Phase 2 (June 2018-March 2019) further integrated blood glucose/cholesterol/chlamydia RDT, with optional peer-navigated referral. Enrolled referred clients completed telephonic follow-up surveys confirming LTC/treatment initiation ≤3 months post-screening. Socio-demographics, screening results, time to LTC/treatment initiation, peer-navigated referral uptake were reported. Analysis included Fisher’s exact, chi-squared, Kruskal Wallis, and Student’s T-tests. Thematic analysis was conducted for open-ended survey responses.ResultsOf all 320 referrals, 40.0% were HIV-infections, 11.9% STIs, 6.6% TB, and 28.8% high/low BP. Of Phase 2-only referrals, 29.4% were for glucose and 23.5% cholesterol. Integrated NCD-HTS had significantly more clients LTC for HIV (76.7%[n = 66/86] vs 52.4%[n = 22/42], p = 0.0052) and within a shorter average time (6–8 days [Interquartile range (IQR):1–18.5] vs 8–13 days [IQR:2–32]) as compared to SOC HTS. Integrated NCD-HTS clients initiated HIV/STIs/BP treatment on average more quickly as compared to SOC HTS (5 days for STIs [IQR:1–21], 8 days for HIV/BP [IQR:5–17 and 2–13, respectively] vs 10 days for STIs [IQR: 4–32], 19.5 days for HIV [IQR:6.5–26.5], 8 days for BP [IQR:2–29)]. Participants chose passive over active referral (89.1% vs 10.9%; p<0.0001). Participants rejecting peer-navigated referral preferred to go alone (55.7% [n = 39/70]). Non-LTC was due to being busy (41.1% [n = 39/95]) and not being ready/refusing treatment (31.6% [n = 30/95]). Normalised results assessed at referral clinic (49.7% [n = 98/196]), prescribed lifestyle modification/monitoring (30.9% [n = 61/196]), and poor clinic flow/congestion and/or further testing required (10.7% [n = 21/196]) were associated with non-treatment initiation.ConclusionSame-day treatment initiation is not achieved across diseases, despite peer-navigated referral. There are psychosocial and health systems barriers at entry to care/treatment initiation. Additional research may identify best strategies for rapid treatment initiation.