Background IOM piloted the use of Ag RDTs for COVID-19 in Iraq, in collaboration with FIND, the Global Alliance for Diagnostics, to facilitate access to testing and understand barriers and opportunities for testing in a displacement context. The purpose was to (i) evaluate the performance metrics of the Sure Status COVID-19 Antigen Card Test in this population; (ii) compare Ag RDT results across high- and low-probability cases, vaccination status, and symptom severity; and (iii) report participant perspectives on Ag RDT use for COVID-19 and other diseases. Methods Secondary analysis was conducted using de-identified cross-sectional data collected from November 2022-March 2023 in four IDP camps in the Kurdistan region of Iraq. Data was collected during the recording, reporting, and monitoring processes of the pilot project using Ag RDTs for COVID-19 among displaced populations. Descriptive statistics and bivariate analyses were conducted in Stata (version 17). Results The observed performance metrics of the Sure Status Ag RDT were as follows: sensitivity = 72.73% (95% CI: 69.56–75.80%); specificity = 99.74% (95% CI: 99.39–100%), PPV = 92.31% (95% CI: 92.31–94.15%), and NPV = 98.85% (95% CI: 98.11–99.58%). Ag RDT uptake was higher among women and symptomatic individuals, and preference for Ag RDTs was especially strong among illiterate respondents. The overall positivity of Ag RDTs and PCR results in this population remained lower than national averages. Concerningly, 23.39% of respondents declined an Ag RDT because they did not believe in COVID-19. Conclusions This pilot program was among the first to explore Ag RDT use in Iraqi Kurdistan. Over 99% of respondents reported satisfaction with their Ag RDT experience, and over 90% wanted to see Ag RDTs available for other diseases. These findings can inform implementation of RDTs and screening protocols for other infectious diseases, and patient perspectives on Ag RDTs for testing and screening of COVID-19 among displaced populations can inform health programming within Iraq and globally.
BackgroundTata MD CHECK SARS-CoV-2 kit 1.0, a CRISPR based reverse transcription PCR (TMC-CRISPR) test was approved by Indian Council of Medical Research (ICMR) for COVID-19 diagnosis in India. To determine the potential for rapid roll-out of this test, we conducted performance characteristic and an operational feasibility assessment (OFA) at a tertiary care setting.InterventionThe study was conducted at an ICMR approved COVID-19 RT-PCR laboratory of King Edward Memorial (KEM) hospital, Mumbai, India. The TMC-CRISPR test was evaluated against the gold-standard RT-PCR test using the same RNA sample extracted from fresh and frozen clinical specimens collected from COVID-19 suspects for routine diagnosis. TMC-CRISPR results were determined manually and using the Tata MD CHECK application. An independent agency conducted interviews of relevant laboratory staff and supervisors for OFA.ResultsOverall, 2,332 (fresh: 2,121, frozen: 211) clinical specimens were analysed of which, 140 (6%) were detected positive for COVID-19 by TMC-CRISPR compared to 261 (11%) by RT-PCR. Overall sensitivity and specificity of CRISPR was 44% (95% CI: 38.1%-50.1%) and 99% (95% CI: 98.2%-99.1%) respectively when compared to RT-PCR. Discordance between TMC-CRISPR and RT-PCR results increased with increasing Ct values and corresponding decreasing viral load (range: <20% to >85%). In the OFA, all participants indicated no additional requirements of training to set up RT PCR. However, extra post-PCR steps such as setting up the CRISPR reaction and handling of detection strips were time consuming and required special training. No significant difference was observed between manual and mobile app-based readings. However, issues such as erroneous results, difficulty in interpretation of faint bands, internet connectivity, data safety and security were highlighted as challenges with the app-based readings.ConclusionThe evaluated version-Tata MD CHECK SARS-CoV-2 kit 1.0 of TMC-CRISPR test cannot be considered as an alternative to the RT-PCR. There is a definite scope for improvement in this assay.
Objective:To describe the changes in tuberculosis case notifications by the private sector after implementation of the Joint Effort for Elimination of Tuberculosis project in India in 2018. Methods:We retrieved data from the project recorded in India's national tuberculosis surveillance system. We analysed data on 95 project districts in six states (Andhra Pradesh, Himachal Pradesh, Karnataka, Punjab including Chandigarh, Telangana and West Bengal) to assess changes in the number of tuberculosis notifications, private provider notifiers and microbiological confirmations of cases from 2017 (baseline) to 2019. We compared case notification rates in districts where the project was implemented with the rates in districts where it was not. Findings:From 2017 to 2019, tuberculosis notifications increased by 138.1% (from 44 695 to 106 404), and case notification rates more than doubled from 20 to 44 per 100 000 population. The number of private notifiers increased by over threefold, from 2912 to 9525, during this period. The number of microbiologically confirmed pulmonary and extra-pulmonary tuberculosis cases notified increased by more than two times (from 10 780 to 25 384) and nearly three times (from 1477 to 4096), respectively. The districts where the project was implemented showed a 150.3% increase in case notification rates per 100 000 population from 2017 to 2019 (from 16.8 to 41.9) while in non-project districts, this increase was only 89.8% (from 6.1 to 11.6). Conclusion:The substantial increase in tuberculosis notifications demonstrate the value of the project in engaging the private sector. Scaling up these interventions is important to consolidate and extend these gains towards tuberculosis elimination.
Background and Aim: Hepatitis infection is common among people who inject drugs (PWID) however their access and compliance to hepatitis care is poor. We piloted a community-led, test and treat strategy model for hepatitis C virus (HCV) care and hepatitis B (HBV) vaccination among PWID in Manipur. Methods: Participants were screened using HCV antibody (Ab) and surface antigen (HBsAg) rapid diagnostic tests. Positive HCV Ab samples were tested using a point-of-care HCV RNA (Molbio TrueNat). Eligible HCV RNA-positive participants were treated on the same day using either sofosbuvir and daclatasvir or sofosbuvir/velpatasvir and were followed for sustained virologic response (SVR) testing. HBsAg- negative participants received the WHO rapid HBV vaccination regimen. Positive HBsAg samples were tested for HBV DNA and referred for treatment. Results: Between November 2021 and February 2022, 643 PWID individuals were approached, of whom 540 (84%) were eligible; 523 (97%) consented to participate and were screened (males 100%; median age 27 years [IQR 23-32]). Of the 259 (50%) who were HCV Ab positive, 167 (64%) were HCV RNA positive. Of those with viremia, 166 (99%) were initiated on treatment on the same day. The median time from screening to treatment was 6.4 hours (range 4.36-12.18 mins). 166 (100%) completed the treatment. 159 (96.9%) complete SVR 12 and 141 (86%) achieved SVR12 while 18 (11%) did not achieve SVR. Twenty-seven (5%) were HBsAg-positive, 4 of them had HCV viremia, and 5 (45%) required HBV treatment; 454 were susceptible to HBV and received 3 doses of HBV vaccine with rapid schedule of 0, 7, 21 days with 100% compliance. Conclusion: Community-led hepatitis care with same day test and treat strategy is feasible and effective. It could be used for HCV micro-elimination in high-risk population and expansion of national program in low-risk population.
ObjectiveTo evaluate the implementation of new operational workflows for simultaneous screening of coronavirus disease 2019 (COVID-19) and tuberculosis at four high-volume COVID-19 testing centres located in tertiary hospitals in Mumbai, India. Methods Each centre already offering antigen-detecting rapid diagnostic tests were equipped with a rapid molecular testing platform for COVID-19 and tuberculosis, sufficient laboratory staff, and reagents and consumables for screening. Using a verbal tuberculosis questionnaire, a patient follow-up agent screened individuals visiting the COVID-19 testing centres. Presumptive tuberculosis patients were asked to provide sputum samples for rapid molecular testing. Subsequently, we reversed our operational workflow to also screen patients visiting tuberculosis outpatient departments for COVID-19, using rapid diagnostic tests. Results From March to December 2021, we screened 14 588 presumptive COVID-19 patients for tuberculosis, of whom 475 (3.3%) were identified as having presumptive tuberculosis. Of these, 288 (60.6%) were tested and 32 individuals (11.1%) were identified as tuberculosis positive (219 cases per 100 000 individuals screened). Of the tuberculosis-positive individuals, three had rifampicin-resistant tuberculosis. Among the remaining 187 presumptive tuberculosis cases not tested, 174 reported no symptoms at follow-up and 13 individuals either refused testing or could not be traced. Of the 671 presumptive tuberculosis cases screened for COVID-19, 17 (2.5%) were positive by antigen rapid diagnostic tests, and five (0.7%) who tested negative, later tested positive on the molecular testing platform (2483 COVID-19 cases per 100 000 individuals screened). Conclusion Simultaneous screening for COVID-19 and tuberculosis in India is operationally feasible and can improve real-time on-site detection of COVID-19 and tuberculosis.
North-west Syria (NWS) is a conflict-affected and unstable area. Due to its limited health infrastructure, accessing advanced COVID-19 testing services is challenging. COVID-19 antigen rapid diagnostic tests (Ag-RDTs) have the potential to overcome this barrier. A pilot project was implemented to introduce Ag-RDTs in NWS, aiming to determine the feasibility, uptake, and results of Ag-RDTs and identify facilitators and barriers to testing with Ag-RDTs. A cross-sectional study design involving secondary analysis of data collected during the project was employed. A local non-governmental organization implemented 25,000 Ag-RDTs that were conducted cross-border by trained community health workers. In total, 27,888 eligible individuals were enrolled, 24,956 (89.5%) consented to test, and 121 (0.5%) were COVID-19-positive. The highest positivity was observed among those with severe COVID-19 symptoms (12.7%), with respiratory illnesses (2.5%), enrolled at hospitals in Afrin (2.5%), and healthcare workers (1.9%). A non-random sample of 236 individuals underwent confirmatory RT-PCR testing. Observed sensitivity, specificity, and positive and negative predictive values were 80.0%, 96.1%, 91.4%, and 90.3%, respectively. Challenges included obtaining informed consent and conducting confirmatory testing. Ag-RDTs represent a feasible screening/diagnostic tool for COVID-19 infections in NWS, with nearly 90% uptake. Embedding Ag-RDTs into COVID-19 testing and screening strategies would be highly beneficial.
Abstract 1) Background: Antigen Rapid Diagnostic Tests (Ag-RDTs) supplements health system’s capacities for COVID-19 testing. Minimal data are available on their use for refugees and migrants. The study aims to describe the feasibility, uptake, and performance of Ag-RDTs among refugees and migrants in Jordan while describing the encountered facilitators and barriers. 2) Methods: A cross-sectional study using data collected from an Ag-RDTs pilot project comprising 17,000 Ag-RDTs in Jordan. 3) Results: About 17,060 people were eligible, of which 99.5% consented. Exactly 99 (0.6%) people were positive. Higher positivity was observed among those with severe COVID-19 symptoms (4.2%) and a history of COVID-19 contact (4.1%). A non-random sample of 209 people underwent confirmatory rt-PCR tests. Observed sensitivity, specificity, positive and negative predictive values of Ag-RDTs were 72%, 97%, 57% and 98.5%, respectively. Key challenges included facing initial hesitancy to undergo Ag-RDTs due to perceived fear of pain, stigma, and isolation, and in getting confirmatory rt-PCR testing. 4) Conclusion: Good feasibility and uptake of Ag-RDTs were demonstrated among refugees and migrants in Jordan. Despite low positivity, certain characteristics were associated with higher rates. Higher specificity and negative predictive values indicate Ag-RDTs can be incorporated within national COVID-19 testingstrategies for ruling out COVID-19.
Objective To describe the changes in tuberculosis case notifications by the private sector after implementation of the Joint Effort for Elimination of Tuberculosis project in India in 2018.Methods We retrieved data from the project recorded in India's national tuberculosis surveillance system. We analysed data on 95 project districts in six states (Andhra Pradesh, Himachal Pradesh, Karnataka, Punjab including Chandigarh, Telangana and West Bengal) to assess changes in the number of tuberculosis notifications, private provider notifiers and microbiological confirmations of cases from 2017 (baseline) to 2019. We compared case notification rates in districts where the project was implemented with the rates in districts where it was not.Findings From 2017 to 2019, tuberculosis notifications increased by 138.1% (from 44 695 to 106 404), and case notification rates more than doubled from 20 to 44 per 100 000 population. The number of private notifiers increased by over threefold, from 2912 to 9525, during this period. The number of microbiologically confirmed pulmonary and extra-pulmonary tuberculosis cases notified increased by more than two times (from 10 780 to 25 384) and nearly three times (from 1477 to 4096), respectively. The districts where the project was implemented showed a 150.3% increase in case notification rates per 100 000 population from 2017 to 2019 (from 16.8 to 41.9) while in non-project districts, this increase was only 89.8% (from 6.1 to 11.6).Conclusion The substantial increase in tuberculosis notifications demonstrate the value of the project in engaging the private sector. Scaling up these interventions is important to consolidate and extend these gains towards tuberculosis elimination.
A lack of laboratory capacity for drug-resistant tuberculosis (DR-TB) testing is a major barrier to DR-TB control. To overcome this barrier, the Central Tuberculosis Division (CTD), Ministry of Health and Family Welfare (MoHFW), Government of India (GoI), and FIND India established a partnership under the National Tuberculosis Elimination Program (NTEP) to strengthen and expand tuberculosis (TB) laboratory diagnostic capabilities. This partnership has led to the establishment of 61 culture & DST laboratories, increasing the testing capacity to a capability of performing over 200,000 liquid cultures and over 170,000 molecular drug sensitivity tests annually. In this study, we assess the data on throughput, efficiency, investment cost, and the capacity of the laboratory services supported by this partnership to understand impact and inform future resource allocation. We estimated the technical efficiency using Stochastic Frontier Analysis (SFA). Our results show that the established laboratory network is operating at 69% efficiency, with the capacity to perform an additional 450,000 cultures and 180,000 first-line molecular drug-susceptibility tests by 2025. This additional capacity, together with current efforts to enhance the laboratory network, has the potential to make a significant contribution to NTEP's TB elimination target by 2025.
Background:India's dominant private healthcare sector is the destination for 60-85% of initial tuberculosis care-seeking. The COVID-19 pandemic in India drastically affected TB case notifications in the first half of 2020. In this survey, we assessed the impact of the first wave of COVID-19 in India on private providers, and changes they adopted in their practice due to the pandemic. Methods:The Joint Effort for Elimination of TB (JEET) is a nationwide Global Fund project implemented across 406 districts in 23 states to extend quality TB services to patients seeking care in private sector. We conducted a rapid survey of 11% (2,750) of active providers engaged under JEET's intense Patient Provider Support Agency (PPSA) model across 15 Indian states in Q1 (February-March) of 2021. Providers were contacted in person or telephonically, and consenting participants were interviewed using a web-based survey tool. Responses from participants were elicited on their practice before COVID-19, during the 2020 lockdowns (March-April 2020) and currently (Q1 2021). Data were adjusted for survey design and non-response, and results were summarised using descriptive statistics and logistic regression. Results:Of the 2,750 providers sampled, 2,011 consented and were surveyed (73 % response). Nearly 50 % were between 30 and 45 years of age, and 51 % were from Uttar Pradesh, Maharashtra and Gujarat. Seventy percent of providers reported reduced daily out-patient numbers in Q1 2021 compared to pre-COVID times. During the lockdown, 898 (40 %) of providers said their facilities were closed, while 323 (11 %) offered limited services including teleconsultation. In Q1 2021, 88 % of provider facilities were fully open, with 10 % providing adjusted services, and 4 % using teleconsultation. Only 2 % remained completely closed. Majority of the providers (92 %) reported not experiencing any delays in TB testing in Q1 2021 compared to pre-COVID times. Only 6 % reported raising costs at their clinic, mostly to cover personal protective equipment (PPE) and other infection control measures, although 60-90 % implemented various infection control measures. Thirty-three percent of TB providers were ordering COVID-19 testing, in addition to TB testing.To adapt, 82% of survey providers implemented social distancing and increased timing between appointments and 83% started conducting temperature checks, with variation by state and provider type, while 89% adopted additional sanitation measures in their facilities. Furthermore, 62% of providers started using PPE, and 13% made physical changes (air filters, isolation of patient areas) to their clinic to prevent infection. Seventy percent of providers stated that infection control measures could decrease TB transmission. Conclusion:Although COVID-19 restrictions resulted in significant declines in patient turn-out at private facilities, our analysis showed that most providers were open and costs for TB care remained mostly the same in Q1 2021. As result of the COVID-19 pandemic, several positive strategies have been adapted by the private sector TB care providers. Since the subsequent COVID-19 waves were more severe or widespread, additional work is needed to assess the impact of the pandemic on the private health sector.
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The COVID-19 pandemic has severely disrupted tuberculosis control efforts and services, particularly in countries with a high burden of tuberculosis.1The Global FundGlobal Fund results report reveals COVID-19 devastating impact on HIV, TB and malaria programs.https://www.theglobalfund.org/en/news/2021-09-08-global-fund-results-report-reveals-covid-19-devastating-impact-on-hiv-tb-and-malaria-programs/Date: Sept 8, 2021Date accessed: December 20, 2021Google Scholar, 2WHOGlobal tuberculosis report 2021.https://www.who.int/publications/i/item/9789240037021Date: Oct 14, 2021Date accessed: December 20, 2021Google Scholar Resources dedicated to identifying and treating tuberculosis have been diverted to the COVID-19 response, with direct effects on tuberculosis programmes. Similarly, measures to prevent COVID-19 transmission, such as lockdowns, have made it harder for people to access tuberculosis testing and care. As a result, 2020 saw a drastic decline in the global number of people who were newly diagnosed and treated for tuberculosis and an increase in deaths from tuberculosis for the first time in more than a decade.2WHOGlobal tuberculosis report 2021.https://www.who.int/publications/i/item/9789240037021Date: Oct 14, 2021Date accessed: December 20, 2021Google Scholar Simultaneous and integrated testing for COVID-19 and tuberculosis is an approach that could improve the detection of both diseases, help to close the gap in tuberculosis diagnosis left by the pandemic, and optimise the use of testing resources in resource-constrained settings.3Ruhwald M Carmona S Pai M Learning from COVID-19 to reimagine tuberculosis diagnosis.Lancet Microbe. 2021; 2: e169-e170Summary Full Text Full Text PDF PubMed Scopus (12) Google Scholar COVID-19 and tuberculosis are two infectious diseases that overlap in terms of their common symptoms (cough and fever) and risk factors for infection and complications. People and communities susceptible to tuberculosis are also likely to be at greater risk of SARS-CoV-2 infection due to overlapping sociodemographic factors, such as crowded living spaces and comorbidities like malnutrition and diabetes. Coinfection with SARS-CoV-2 and tuberculosis is also associated with poor outcomes: studies indicate that people with tuberculosis have a substantially greater risk of death from COVID-19 than those without tuberculosis.4Sy KTL Haw NJL Uy J Previous and active tuberculosis increases risk of death and prolongs recovery in patients with COVID-19.Infect Dis (Lond). 2020; 52: 902-907Crossref PubMed Scopus (46) Google Scholar, 5Western Cape Department of Health in collaboration with the National Institute for Communicable Diseases, South AfricaRisk factors for coronavirus disease 2019 (COVID-19) death in a population cohort study from the Western Cape province, South Africa.Clin Infect Dis. 2021; 73: e2005-e2015Crossref PubMed Scopus (144) Google Scholar A further concern is that reduced immunity and lung inflammation from COVID-19, and the effects of corticosteroids used to treat COVID-19, might lead to the progression of Mycobacterium tuberculosis infection to symptomatic disease or the worsening of active tuberculosis.6Gopalaswamy R Subbian S Corticosteroids for COVID-19 therapy: potential implications on tuberculosis.Int J Mol Sci. 2021; 223773Crossref PubMed Scopus (17) Google Scholar Access to diagnostic testing for COVID-19 and tuberculosis is an essential first step in the care cascade to reduce the transmission of both diseases and appropriately manage those affected by them. Consequently, there is a rationale for improving access to testing for COVID-19 and tuberculosis through the implementation of simultaneous testing, particularly in countries with a high burden of tuberculosis, to mitigate the impact of the ongoing pandemic on tuberculosis services and identify people who might be at high risk from both diseases. Several countries have trialled simultaneous testing strategies for COVID-19 and tuberculosis during the pandemic, including Indonesia,7XINHUANET.comGoogle ScholarIndonesia steps up battle against tuberculosis amid COVID-19 pandemic.http://www.xinhuanet.com/english/2020-07/21/c_139229561.htmDate: July 21, 2020Date accessed: December 20, 2021Google Scholar South Africa,8DevidiscourseProvinces experimenting with combining TB and COVID-19 screening.https://www.devdiscourse.com/article/health/1197889-provinces-experimenting-with-combining-tb-and-covid-19-screeningDate: 2020Date accessed: December 20, 2021Google Scholar Nigeria,9WHO AfricaKaduna State and WHO scale up COVID-19 and TB search with mobile testing in communities.https://www.afro.who.int/news/kaduna-state-and-who-scale-covid-19-and-tb-search-mobile-testing-communitiesDate: Aug 6, 2020Date accessed: December 20, 2021Google Scholar and India.10Government of India Ministry of Health and Family WelfareRapid response plan to mitigate impact of COVID-19 pandemic on TB epidemic and national TB elimination program (NTEP) activities in India-Reg.https://tbcindia.gov.in/showfile.php?lid=3551Date: Sept 4, 2020Date accessed: December 20, 2021Google Scholar Notably, India's Ministry of Health and Family Welfare issued a rapid response plan to mitigate the impact of the COVID-19 pandemic on tuberculosis control efforts in September, 2020, which included COVID-19 screening for all patients diagnosed with tuberculosis and tuberculosis screening for all patients with confirmed COVID-19.10Government of India Ministry of Health and Family WelfareRapid response plan to mitigate impact of COVID-19 pandemic on TB epidemic and national TB elimination program (NTEP) activities in India-Reg.https://tbcindia.gov.in/showfile.php?lid=3551Date: Sept 4, 2020Date accessed: December 20, 2021Google Scholar FIND, the global alliance for diagnostics, have been working to address the paucity of diagnostics for tuberculosis and COVID-19 across low-income and middle-income countries. As part of these efforts, FIND have supported two simultaneous testing initiatives in India. The first, in partnership with the Confluence for Health Action and Transformation Foundation, is supplementing the reach and effectiveness of the COVID-19 response at five high-volume tertiary hospitals in Mumbai. The project enables the provision of rapid, onsite Truenat (Molbio Diagnostics; Verna, India) PCR testing for those who test negative for SARS-CoV-2 on rapid antigen tests but have symptoms suggestive of COVID-19 or tuberculosis, aiding patient management and the identification of COVID-19 and tuberculosis hotspots. The second is being conducted in India's private health-care sector via the Joint Effort for Elimination of Tuberculosis (JEET), which is an innovative initiative for tuberculosis that connects private health-care facilities, laboratories, and medical practitioners with the national public health programme to improve access to affordable tuberculosis diagnostics and treatment. The JEET teams have worked to sensitise private sector health-care providers to tuberculosis and COVID-19 testing guidelines and key activities have included (1)establishing linkages for simultaneous testing in eligible patients with presumptive tuberculosis across private health facilities, (2) providing education on tuberculosis and COVID-19 diagnostic services and guidelines under the public sector, and (3) educating patients with tuberculosis of COVID-19-related precautions and symptoms. These experiences in India have shown the value of simultaneous COVID-19 and tuberculosis testing, in terms of increasing access to diagnostics, and that operational workflows for COVID-19 and tuberculosis testing can work harmoniously when combined. Challenges encountered during the implementation of simultaneous testing largely related to shortages of staff and personal protective equipment, which at times limited the screening of patients at hospitals and in the field. Informed by FIND's experiences in India, we have outlined key topics for countries considering the implementation of simultaneous testing, divided into policy, operational, and technical considerations (appendix). Several research gaps exist around simultaneous testing. In particular, the development of integrated COVID-19 and tuberculosis tests (ie, those that can be done on one platform with the same sample) would help to streamline and increase the cost-efficiency of simultaneous testing. Other key areas that require further investigation include the evaluation of optimal settings for simultaneous testing (eg, in the community or a facility) and the diagnostic yield and cost-effectiveness of simultaneous testing (ie, the extent to which simultaneous testing of COVID-19 and tuberculosis enables the diagnosis of both conditions, and the relative costs and benefits of the intervention). Future efforts should also include the adaptation and validation of COVID-19 symptom screening apps, which consider factors such as geography, age, and risk profile, for use in tuberculosis diagnosis, and research into the optimal sampling strategy for COVID-19 and tuberculosis testing (eg, tongue swabs or saliva). To conclude, although the COVID-19 pandemic might have set back progress in tuberculosis testing and care, there is an opportunity to leverage the innovations in mass testing implemented as part of the pandemic response to close tuberculosis testing gaps and help to control the transmission of both diseases. The implementation of innovative simultaneous testing strategies for tuberculosis and COVID-19 could improve access to testing among populations at greatest risk for both diseases, and early simultaneous testing efforts suggest that the approach is feasible. The considerations shared here, informed by simultaneous testing projects in India, can provide a starting point for countries to design operational research projects to assess the impact of simultaneous testing guidelines for tuberculosis and COVID-19. Future work on the outlined research gaps would also be valuable to provide further evidence for these policies and bring about the development of integrated simultaneous testing for COVID-19 and tuberculosis. All authors are employees of FIND. FIND received grants from the Bill & Melinda Gates Foundation and The Global Fund to Fight AIDS, Tuberculosis and Malaria for the simultaneous testing efforts from which this Comment draws the lessons learned. FIND is co-convenor of the Access to COVID-19 Tools Accelerator Diagnostics Pillar along with The Global Fund. We declare no other competing interests. Writing support was provided by Talya Underwood of Anthos Communications, UK, and was funded by FIND according to Good Publication Practice guidelines. Download .pdf (.23 MB) Help with pdf files Supplementary appendix
Background: Both Hepatitis C and HIV are more prevalent among prisoners than in the general community. This cohort of prison inmates provides an unique opportunity to screen and treat these infections. Aims: To describe our experience of screening and managing patients with Hepatitis C and HIV co-infection in inmates of prisons of Punjab. Methods: All inmates in 9 central-prisons of Punjab were screened for anti-HCV from November(2019)- December(2020). HCV viremia was confirmed using RT-PCR. Co-infection with HIV and antiretroviral treatment (ART) details were gleaned from the medical-records of the patients. Results: A total of 15,369 individuals were screened. Three thousand three hundred and forty-four (21.7%) individuals were seropositive for anti-HCV among which 2267 (14.7%) had detectable HCV RNA. HIV co-infection was present in 126 (5.6%) of these patients. All these patients were on ART [Tenofovir-Lamivudine-Efavirenz: n=124 (98.4%) and Zidovudine- Lamivudine-Nevirapine: n= 2 (1.6%)]. History of intravenous drug abuse, needlestick injury and high- risk sexual behaviour were present in 67 (53.2%), 7 (5.6%) and 3 (2.4%) patients, respectively. All patients were non-cirrhotic with a median APRI and FIB-4 of 0.59 (0.39-0.81) and 0.97 (0.7-1.32), respectively. Eighty-nine (70.6%) patients have been initiated on DAAs with Sofosbuvir and Daclatasvir, with the dose of Daclatasvir being increased to 90 mg in those receiving Efavirenz as part of antiretroviral regimen. Planned 12-weeks of therapy has been completed in 65 (51.5%) patients. So far, HCV RNA has been quantified in 30 (24.6%) at 12-weeks after end of therapy with attainment of SVR in 27 (90%) patients. Conclusions: Prevalence of Hepatitis C infection in prisons of Punjab is 14.7%, and 5.6% of these patients have HIV co-infection. Screening and treatment of Hepatitis C and HIV with modern oral therapies in prison inmates may help to decrease the overall burden of these infections with common modes of transmission.
BACKGROUND AND AIMS:India has a significant burden of hepatitis C virus (HCV) infection and has committed to achieving national elimination by 2030. This will require a substantial scale-up in testing and treatment. The "HEAD-Start Project Delhi" aimed to enhance HCV diagnosis and treatment pathways among the general population. METHODS:A prospective study was conducted at 5 district hospitals (Arm 1: one-stop shop), 15 polyclinics (Arm 2: referral for viral load (VL) testing and treatment) and 62 screening camps (Arm 3: referral for treatment). HCV prevalence, retention in the HCV care cascade, and turn-around time were measured. RESULTS:Between January and September 2019, 37 425 participants were screened for HCV. The median (IQR) age of participants was 35 (26-48) years, with 50.4% male and 49.6% female. A significantly higher proportion of participants in Arm 1 (93.7%) and Arm 3 (90.3%) received a VL test compared with Arm 2 (52.5%, P < .001). Of those confirmed positive, treatment was initiated at significantly higher rates for participants in both Arms 1 (85.6%) and 2 (73.7%) compared to Arm 3 (41.8%, P < .001). Arm 1 was found to be a cost-saving strategy compared to Arm 2, Arm 3, and no action. CONCLUSIONS:Delivery of all services at a single site (district hospitals) resulted in a higher yield of HCV seropositive cases and retention compared with sites where participants were referred elsewhere for VL testing and/or treatment. The highest level of retention in the care cascade was also associated with the shortest turn-around times.
Background Bringing reliable and accurate tuberculosis (TB) diagnosis closer to patients is a key priority for global TB control. Molbio Diagnostics have developed the Truenat point-of-care molecular assays for detection of TB and rifampicin (RIF) resistance. Methods We conducted a prospective multicentre diagnostic accuracy study at 19 primary healthcare centres and seven reference laboratories in Peru, India, Ethiopia and Papua New Guinea to estimate the diagnostic accuracy of the point-of-care Truenat MTB, MTB Plus and MTB-RIF Dx assays for pulmonary TB using culture and phenotypic drug susceptibility testing as the reference standard, compared with Xpert MTB/RIF or Ultra. Results Of 1807 enrolled participants with TB signs/symptoms, 24% were culture-positive for Mycobacterium tuberculosis, of which 15% were RIF-resistant. In microscopy centres, the pooled sensitivity of Truenat MTB and Truenat MTB Plus was 73% (95% CI 67–78%) and 80% (95% CI 75–84%), respectively. Among smear-negative specimens, sensitivities were 36% (95% CI 27–47%) and 47% (95% CI 37–58%), respectively. Sensitivity of Truenat MTB-RIF was 84% (95% CI 62–95%). Truenat assays showed high specificity. Head-to-head comparison in the central reference laboratories suggested that the Truenat assays have similar performance to Xpert MTB/RIF. Conclusion We found the performance of Molbio's Truenat MTB, MTB Plus and MTB-RIF Dx assays to be comparable to that of the Xpert MTB/RIF assay. Performing the Truenat tests in primary healthcare centres with very limited infrastructure was feasible. These data supported the development of a World Health Organization policy recommendation of the Molbio assays.