Characterizing the role of informal payments in the delivery of pathology and clinical laboratory services.

OBJECTIVES: Informal payments (IPs) are unofficial cash or in-kind payments for goods or services that should be covered by the health care system. They are a common but regressive method of financing health care in low- and lower-middle-income countries (LMICs). This study aims to characterize the prevalence and impact of IPs on pathology and laboratory medicine (PALM) services. METHODS: From September 2021 to September 2022, PALM staff were surveyed about the frequency, determinants, and impacts of IPs in their respective workplaces. RESULTS: In total, 268 responses were received, and 46.6% (125/268) reported experience with IPs. These 125 participants were more likely to work in the public sector and in LMICs. Approximately 65% reported accepting IPs to perform tests or release results. Obtaining faster results was the most commonly perceived reason for patients offering IPs. Overall, participants reported that IPs had more negative than positive impacts on their workplace. CONCLUSIONS: This represents a first step in characterizing IPs within PALM and how this practice may affect access to these services in LMICs. Specifically, the fact that faster turnaround time was the most frequently perceived reason for offering IPs uncovers a potential barrier to improving PALM capacity in these regions.

Audit of laboratory sensitivity of human papillomavirus and cytology testing in a cervical screening program.

The globally recommended public health policy for cervical screening is primary human papillomavirus (HPV) screening with cytology triaging of positives. To ensure optimal quality of laboratory services we have conducted regular audits of cervical smears taken before cervical cancer or cancer in situ (CIN3+) within an HPV-based screening program. The central cervical screening laboratory of Stockholm, Sweden, identified cases of CIN3+ who had had a previous cervical screening test up to 3 years before and randomly selected 300 cervical liquid-based cytology (LBC) samples for auditing. HPV testing with Roche Cobas was performed either at screening or with biobanked samples. HPV negative samples and subsequent biopsies were retrieved and tested with modified general primer HPV PCR and, if still HPV-negative, the LBCs and biopsies were whole genome sequenced. The Cobas 4800 detected HPV in 1020/1052 (97.0%) LBC samples taken before CIN3+. Further analyses found HPV in 28 samples, with nine of those containing HPV types not targeted by the Cobas 4800 test. There were 4 specimens (4/1052, 0.4%) where no HPV was detected. By comparison, the proportion of CIN3+ cases that were positive in a previous cytology were 91.6%. We find that the routine HPV screening test had a sensitivity in the real-life screening program of 97.0%. Regular laboratory audits of cervical samples taken before CIN3+ can be readily performed within a real-life screening program and provide assurance that the laboratory of the real-life program has the expected performance.

Impact of the COVID-19 pandemic on clinical research activities: Survey of study participants and health care workers participating in a hypertension trial in Vietnam.

BACKGROUND: The COVID-19 pandemic has had a profound worldwide impact. Vietnam, a lower middle-income country with limited resources, has successfully slowed this pandemic. The objectives of this report are to explore the impact of the COVID-19 pandemic on the research activities of an ongoing hypertension trial using a storytelling intervention in Vietnam. METHODS: Data were collected in a mixed-methods study among 86 patients and 10 health care workers participating in a clinical trial designed to improve hypertension control. Several questions related to the impact of COVID-19 on patient's daily activities and adherence to the study interventions were included in the follow-up visits. A focus group discussion was conducted among health care workers to discuss the impact of COVID-19 on research related activities. RESULTS: Fewer patients in the intervention group reported that they faced difficulties in adhering to prescribed study interventions, wanted to receive a call from a dedicated hotline, or have a visit from a community health worker as compared with those in the comparison group. Most study patients are willing to participate in future health research studies. When asked about the potential use of mobile phones in health research studies, fewer patients in the intervention group felt comfortable using a mobile phone for the delivery of intervention and interviews compared with those in the comparison condition. Community health workers shared that they visited patient's homes more often than previously due to the pandemic and health care workers had to perform more virus containment activities without a corresponding increase in ancillary staff. CONCLUSIONS: Both patients and health care workers in Vietnam faced difficulties in adhering to recommended trial interventions and procedures. Multiple approaches for intervention delivery and data collection are needed to overcome these difficulties during future health crises and enhance the implementation of future research studies. TRIAL REGISTRATION: ClinicalTrials.gov. Registration number: https://clinicaltrials.gov/ct2/show/NCT03590691 (registration date July 17, 2018).

The challenge of COVID-19 for a Clinical Microbiology Department.

OBJECTIVES: To quantify the workload and cost overload that the COVID-19 pandemic has meant for a Clinical Microbiology laboratory in a real-life scenario. METHODS: We compared the number of samples received, their distribution, the human resources, and the budget of a Microbiology laboratory in the COVID pandemic (March-December 2020) with the same months of the previous year. RESULTS: the total number of samples processed in the Clinical Microbiology laboratory in March to December 2020 increased 96.70% with respect to 2019 (from 246,060 to 483,993 samples), reflecting an increment of 127.50% when expressed as samples/1000 admissions (from 6057 to 13,780). The increase in workload was mainly at the expense of the virology (+2058%) and serology (+86%) areas. Despite additional personnel hiring, the samples processed per technician increased 12.5%. The extra cost attributed to Microbiology amounts to 6,616,511 euros (114.8%). CONCLUSIONS: This is the first study to provide quantitative figures about workload and cost increase caused by the COVID-19 in a Microbiology laboratory.

Evaluation of the Clinical Performance of 7 Serological Assays for SARS-CoV-2 for Use in Clinical Laboratories.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological assays have emerged as a response to the global pandemic, warranting studies evaluating their clinical performance. This study investigated 7 commercially available SARS-CoV-2 serological assays in samples from noninfected individuals and hospitalized patients. METHODS: SARS-CoV-2 qualitative serological assays by Abbott (IgG), Beckman (IgG), DiaSorin (IgG), EUROIMMUN (IgG and IgA), Roche and Bio-Rad (Total) were evaluated using specimens collected pre-December 2019 (n = 393), from nucleic acid amplification testing (NAAT) negative patients (n = 40), and from 53 patients with COVID-19 by NAAT collected 3-21 days post-onset of symptoms (POS) (N = 83). Negative agreement (NA), positive agreement (PA), and positive and negative predictive values (PPV and NPV) at prevalences of 5% and 10% were calculated. RESULTS: The overall %NA; 95% CI in the negative samples were: Roche 99.8%; 99.3-100.2, Beckman 99.8%; 98.7-100.0, Abbott and Bio-Rad 99.3%; 98.0-99.9, DiaSorin 98.4; 97.2-99.6, EUROIMMUN IgG 97.5%; 95.5-98.7, and EUROIMMUN IgA 79.7%; 75.9-83.5), accounting for positive/equivocal results as false positives. The %PA; 95% CI in samples collected 14+ days POS (n = 24) were: Bio-Rad 83.3%; 68.4-98.2, Abbott and Roche 79.2%; 62.9-95.4, EUROIMMUN IgA 70.8%; 52.6-89.0, Beckman 58.3%; 38.6-78.1, DiaSorin 54.2; 34.2-74.1, and EUROIMMUN IgG 50.0%; 30.0-70.0, accounting for negative/equivocal results as false negatives. NPVs ranged from 97.4%-98.9% and 94.7%-97.7% for prevalences 5% and 10%, respectively. PPVs ranged from 15.5%-94.8% and 27.9%-97.4% for prevalences 5% and 10%, respectively. CONCLUSION: The Roche and Beckman assays resulted in fewer false positives, followed by the Bio-Rad and Abbott assays. While the Bio-Rad assay demonstrated higher antibody detection in COVID-19-positive patients, PA claims cannot be established with a high level of confidence in our sample population.

Thyroid malignancy rates according to the Bethesda reporting system in Israel - A multicenter study.

INTRODUCTION: The Bethesda System for Reporting Thyroid Cytopathology was developed in 2007 to facilitate an accurate, reproducible communication of thyroid fine-needle aspiration (FNA) interpretations between clinicians and cytopathologists and to serve as a guide for treatment. Based on large patient series, the system details the risk of malignancy for each category as well as a suggested management for each FNA result. Though this system has been widely adopted, there are only few studies to determine whether results are applicable for Israel. METHODS: A multicenter, retrospective analysis of medical charts of all patients who underwent thyroid surgery between January 1st, 2012 and December 31st, 2016 in four medical centers in Israel was performed. Data was analyzed for the overall risk of malignancy for the Bethesda system groups as well as comparison between the different laboratories performing the test. RESULTS: Records of 810 thyroidectomies in which preoperative cytological reports and final pathology were available and reviewed. The malignancy rates according to the Bethesda groups' I-VI for our cohort were: 27.8%, 17.6%, 41.4%, 41.4%, 86.9%, and 98.1% respectively. Similar results were seen when results were analyzed according to the different laboratories performing the tests. CONCLUSIONS: Post-surgical review of all Bethesda groups had higher malignancy rates than those reported in the original report. These results indicate a difference in the malignancy rates for the different Bethesda system groups in Israel compared to those reported. Physicians are encouraged to use data validated for their own country or patients' community in addition to published values.

Clinical Predictors of SARS-CoV-2 Testing Pressure on Clinical Laboratories: A Multinational Study Analyzing Google Trends and Over 100 Million Diagnostic Tests.

OBJECTIVE: Evidence has shown that Google searches for clinical symptom keywords correlates with the number of new weekly patients with COVID-19. This multinational study assessed whether demand for SARS-CoV-2 tests could also be predicted by Google searches for key COVID-19 symptoms. METHODS: The weekly number of SARS-CoV-2 tests performed in Italy and the United States was retrieved from official sources. A concomitant electronic search was performed in Google Trends, using terms for key COVID-19 symptoms. RESULTS: The model that provided the highest coefficient of determination for the United States (R2 = 82.8%) included a combination of searching for cough (with a time lag of 2 weeks), fever (with a time lag of 2 weeks), and headache (with a time lag of 3 weeks; the time lag refers to the amount of time between when a search was conducted and when a test was administered). In Italy, headache provided the model with the highest adjusted R2 (86.8%), with time lags of both 1 and 2 weeks. CONCLUSION: Weekly monitoring of Google Trends scores for nonspecific COVID-19 symptoms is a reliable approach for anticipating SARS-CoV-2 testing demands ~2 weeks in the future.

Impact of delays to incubation and storage temperature on blood culture results: a multi-centre study.

BACKGROUND: Blood cultures are one of the most important tests performed by microbiology laboratories. Many hospitals, particularly in low and middle-income countries, lack either microbiology services or staff to provide 24 h services resulting in delays to blood culture incubation. There is insufficient guidance on how to transport/store blood cultures if delays before incubation are unavoidable, particularly if ambient temperatures are high. This study set out to address this knowledge gap. METHODS: In three South East Asian countries, four different blood culture systems (two manual and two automated) were used to test blood cultures spiked with five common bacterial pathogens. Prior to incubation the spiked blood culture bottles were stored at different temperatures (25 °C, in a cool-box at ambient temperature, or at 40 °C) for different lengths of time (0 h, 6 h, 12 h or 24 h). The impacts of these different storage conditions on positive blood culture yield and on time to positivity were examined. RESULTS: There was no significant loss in yield when blood cultures were stored < 24 h at 25 °C, however, storage for 24 h at 40 °C decreased yields and longer storage times increased times to detection. CONCLUSION: Blood cultures should be incubated with minimal delay to maximize pathogen recovery and timely result reporting, however, this study provides some reassurance that unavoidable delays can be managed to minimize negative impacts. If delays to incubation ≥ 12 h are unavoidable, transportation at a temperature not exceeding 25 °C, and blind sub-cultures prior to incubation should be considered.

An Australian diagnostic microbiology surge response to the COVID-19 pandemic.

Diagnostic microbiology services form a critical component of the response to infectious disease outbreaks. Like previous respiratory virus pandemics, the COVID-19 pandemic has placed significant strains on the standing capacity of laboratories around the world. In this case study, we describe the surge response required by our laboratory to meet the fluctuating demand for SARS-CoV-2 in our regional pathology service in Western Sydney, Australia between March and May 2020. While the overall number of SARS-CoV-2 PCR positive cases was relatively low compared to other Australian local health districts, testing numbers were highly unpredictable and changed on a weekly basis as local outbreaks were detected. As with other laboratories, numerous other challenges were also faced during this period, including the requirement to introduce a new and unaccredited diagnostic PCR assay for SARS-CoV-2, local and global shortages of reagents for sampling and sample processing, and a significant institutional SARS-CoV-2 outbreak in our laboratory catchment area. A successful service delivery during this period could only be maintained by a dynamic whole-of-laboratory and organizational response including (1) operational changes to the hours of service and the expansion of diagnostic testing at our laboratory site and other sites within our organization (2) careful management of specialist staff and re-training and recruitment of additional staff (3) changes to laboratory workflows to improve SARS-CoV-2 PCR test turnaround time and to accommodate limits to precious laboratory reagents; (4) clear communication within our laboratory and the NSW Health Pathology organization; and (5) collaborative co-ordination and support by NSW Health Pathology.

COVID-19 Pandemic Planning: Simulation Models to Predict Biochemistry Test Capacity for Patient Surges.

BACKGROUND: Patient surges beyond hospital capacity during the initial phase of the COVID-19 pandemic emphasized a need for clinical laboratories to prepare test processes to support future patient care. The objective of this study was to determine if current instrumentation in local hospital laboratories can accommodate the anticipated workload from COVID-19 infected patients in hospitals and a proposed field hospital in addition to testing for non-infected patients. METHODS: Simulation models predicted instrument throughput and turn-around-time for chemistry, ion-selective-electrode, and immunoassay tests using vendor-developed software with different workload scenarios. The expanded workload included tests from anticipated COVID patients in 2 local hospitals and a proposed field hospital with a COVID-specific test menu in addition to the pre-pandemic workload. RESULTS: Instrumentation throughput and turn-around time at each site was predicted. With additional COVID-patient beds in each hospital, the maximum throughput was approached with no impact on turnaround time. Addition of the field hospital workload led to significantly increased test turnaround times at each site. CONCLUSIONS: Simulation models depicted the analytic capacity and turn-around times for laboratory tests at each site and identified the laboratory best suited for field hospital laboratory support during the pandemic.

Audit in surgical histopathology at a tertiary healthcare center: Study of preanalytical and analytical phase.

CONTEXT: An audit aims to verify conformance to required processes, assess their implementation, and define the targets of quality control. AIMS: To evaluate preanalytic and analytic phases of surgical histopathology in a tertiary healthcare center. SETTING AND DESIGN: An observational retrospective and prospective study over 3 months each of year 2013 and 2014. MATERIALS AND METHODS: Biopsy, small resections, large organ resections, bone marrow aspirate/biopsy (BMA/BMB), and frozen section samples received in surgical histopathology were categorized as I to V, respectively. A manual audit was done for preanalytical phase (adequacy of clinical information and grossing adequacy) and analytical phase [turnaround time (TAT) and tissue section quality]. STATISTICAL ANALYSIS: Qualitative data was assessed by Chi-Square test. Quantitative data was assessed using One-Way Analysis of Variance. RESULTS: Among 3179 total cases, category I to V had 1558 (49%), 1099 (34.6%), 342 (10.8%), 124 (3.8%), and 56 (1.8%) cases, respectively. Category I had shortest TAT but maximum number of inadequately sent specimens and recuts. Category III had maximum cases with inadequate clinical history, grossing errors, additional sections, and longest TAT. Category IV had maximum cases with poor quality sections. Category V had maximum cases with inadequate demographic details and clinical investigations. BMB (114, 91.9%) was more useful than BMA for diagnosis. Mean TAT for fixed tissues and frozen tissues was 3.6 ± 1.8 days and 26.6 ± 11.2 min, respectively. CONCLUSIONS: Total 25% of annual workload was studied by an observational, manual audit. Quality indicators were achieved as per international norms despite limited resources. Remedial actions were suggested for technicians, clinicians, and pathologists to minimize errors.

Clinical and molecular practice of European thoracic pathology laboratories during the COVID-19 pandemic. The past and the near future.

BACKGROUND: This study evaluated the consequences in Europe of the COVID-19 outbreak on pathology laboratories orientated toward the diagnosis of thoracic diseases. MATERIALS AND METHODS: A survey was sent to 71 pathology laboratories from 21 European countries. The questionnaire requested information concerning the organization of biosafety, the clinical and molecular pathology, the biobanking, the workload, the associated research into COVID-19, and the organization of education and training during the COVID-19 crisis, from 15 March to 31 May 2020, compared with the same period in 2019. RESULTS: Questionnaires were returned from 53/71 (75%) laboratories from 18 European countries. The biosafety procedures were heterogeneous. The workload in clinical and molecular pathology decreased dramatically by 31% (range, 3%-55%) and 26% (range, 7%-62%), respectively. According to the professional category, between 28% and 41% of the staff members were not present in the laboratories but did teleworking. A total of 70% of the laboratories developed virtual meetings for the training of residents and junior pathologists. During the period of study, none of the staff members with confirmed COVID-19 became infected as a result of handling samples. CONCLUSIONS: The COVID-19 pandemic has had a strong impact on most of the European pathology laboratories included in this study. Urgent implementation of several changes to the organization of most of these laboratories, notably to better harmonize biosafety procedures, was noted at the onset of the pandemic and maintained in the event of a new wave of infection occurring in Europe.

Surveillance of Coronavirus Disease 2019 (COVID-19) Testing in Clinical Laboratories in Korea.

In response to the ongoing coronavirus disease 2019 (COVID-19) pandemic, an online laboratory surveillance system was established to monitor severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) real-time reverse transcription-PCR (rRT-PCR) testing capacities and results. SARS-CoV-2 rRT-PCR testing data were collected from 97 clinical laboratories, including 84 medical institutions and 13 independent clinical laboratories in Korea. We assessed the testing capacities to utilize SARS-CoV-2 rRT-PCR based on surveillance data obtained from February 7th to June 4th, 2020 and evaluated positive result characteristics according to the reagents used and sample types. A total of 1,890,319 SARS-CoV-2 rRT-PCR testing were performed, 2.3% of which were positive. Strong correlations were observed between the envelope (E) gene and RNA-dependent RNA polymerase (RdRp)/nucleocapsid (N) genes threshold cycle (Ct) values for each reagent. No statistically significant differences in gene Ct values were observed between the paired upper and lower respiratory tract samples, except in the N gene for nasopharyngeal swab and sputum samples. Our study showed that clinical laboratories in Korea have rapidly expanded their testing capacities in response to the COVID-19 outbreak, with a peak daily capacity of 34,193 tests. Rapid expansion in testing capacity is a critical component of the national response to the ongoing pandemic.

Simple Questionnaires to Improve Pooling Strategies for SARS-CoV-2 Laboratory Testing.

Background: Liberal PCR testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is key to contain the coronavirus disease 2019 (COVID-19) pandemic. Combined multi-sample testing in pools instead of single tests might enhance laboratory capacity and reduce costs, especially in low- and middle-income countries. Objective: The purpose of our study was to assess the value of a simple questionnaire to guide and further improve pooling strategies for SARS-CoV-2 laboratory testing. Methods: Pharyngeal swabs for SARS-CoV-2 testing were obtained from healthcare and police staff, hospital inpatients, and nursing home residents in the southwestern part of Germany. We designed a simple questionnaire, which included questions pertaining to a suggestive clinical symptomatology, recent travel history, and contact with confirmed cases to stratify an individual's pre-test probability of having contracted COVID-19. The questionnaire was adapted repeatedly in face of the unfolding pandemic in response to the evolving epidemiology and observed clinical symptomatology. Based on the response patterns, samples were either tested individually or in multi-sample pools. We compared the pool positivity rate and the number of total PCR tests required to obtain individual results between this questionnaire-based pooling strategy and randomly assembled pools. Findings: Between March 11 and July 5, 2020, we processed 25,978 samples using random pooling (n = 6,012; 23.1%) or questionnaire-based pooling (n = 19,966; 76.9%). The overall prevalence of SARS-CoV-2 was 0.9% (n = 238). Pool positivity (14.6% vs. 1.2%) and individual SARS-CoV-2 prevalence (3.4% vs. 0.1%) were higher in the random pooling group than in the questionnaire group. The average number of PCR tests needed to obtain the individual result for one participant was 0.27 tests in the random pooling group, as compared to 0.09 in the questionnaire-based pooling group, leading to a laboratory capacity increase of 73% and 91%, respectively, as compared to single PCR testing. Conclusions: Strategies that combine pool testing with a questionnaire-based risk stratification can increase laboratory testing capacities for COVID-19 and might be important tools, particularly in resource-constrained settings.

Impact of the COVID-19 pandemic on testing services for HIV, viral hepatitis and sexually transmitted infections in the WHO European Region, March to August 2020.

We present preliminary results of a coronavirus disease (COVID-19) impact assessment on testing for HIV, viral hepatitis and sexually transmitted infections in the WHO European Region. We analyse 98 responses from secondary care (n = 36), community testing sites (n = 52) and national level (n = 10). Compared to pre-COVID-19, 95% of respondents report decreased testing volumes during March-May and 58% during June-August 2020. Reasons for decreases and mitigation measures were analysed.

[Management of a global health crisis: first COVID-19 disease feedback from Overseas and French-speaking countries medical biologists]. / Gestion d'une crise sanitaire mondiale : premiers retours d'expérience de biologistes médicaux d'Outre-mer et de francophonie face au COVID-19.

The French society of clinical biology "Biochemical markers of COVID-19" has set up a working group with the primary aim of reviewing, analyzing and monitoring the evolution of biological prescriptions according to the patient's care path and to look for markers of progression and severity of the disease. This study covers all public and private sectors of medical biology located in metropolitan and overseas France and also extends to the French-speaking world. This article presents the testimonies and data obtained for the "Overseas and French-speaking countries" sub-working group made up of 45 volunteer correspondents, located in 20 regions of the world. In view of the delayed spread of the SARS-CoV-2 virus, the overseas regions and the French-speaking regions have benefited from feedback from the first territories confronted with COVID-19. Thus, the entry of the virus or its spread in epidemic form could be avoided, thanks to the rapid closure of borders. The overseas territories depend very strongly on air and/or sea links with the metropolis or with the neighboring continent. The isolation of these countries is responsible for reagent supply difficulties and has necessitated emergency orders and the establishment of stocks lasting several months, in order to avoid shortages and maintain adequate patient care. In addition, in countries located in tropical or intertropical zones, the diagnosis of COVID-19 is complicated by the presence of various zoonoses (dengue, Zika, malaria, leptospirosis, etc.).

Automated digital reporting of clinical laboratory information to national public health surveillance systems, results of a EU/EEA survey, 2018.

BackgroundTimely reporting of microbiology test results is essential for infection management. Automated, machine-to-machine (M2M) reporting of diagnostic and antimicrobial resistance (AMR) data from laboratory information management systems (LIMS) to public health agencies improves timeliness and completeness of communicable disease surveillance.AimWe surveyed microbiology data reporting practices for national surveillance of EU-notifiable diseases in European Union/European Economic Area (EU/EEA) countries in 2018.MethodsEuropean Centre for Disease Prevention and Control (ECDC) National Microbiology and Surveillance Focal Points completed a questionnaire on the modalities and scope of clinical microbiology laboratory data reporting.ResultsComplete data were provided for all 30 EU/EEA countries. Clinical laboratories used a LIMS in 28 countries. LIMS data on EU-notifiable diseases and AMR were M2M-reported to the national level in 14 and nine countries, respectively. In the 14 countries, associated demographic data reported allowed the de-duplication of patient reports. In 13 countries, M2M-reported data were used for cluster detection at the national level. M2M laboratory data reporting had been validated against conventional surveillance methods in six countries, and replaced those in five. Barriers to M2M reporting included lack of information technology support and financial incentives.ConclusionM2M-reported laboratory data were used for national public health surveillance and alert purposes in nearly half of the EU/EEA countries in 2018. Reported data on infectious diseases and AMR varied in extent and disease coverage across countries and laboratories. Improving automated laboratory-based surveillance will depend on financial and regulatory incentives, and harmonisation of health information and communication systems.

Rapid Versus Laboratory-Based Testing for HIV and Hepatitis C at a Drug Detoxification Treatment Center: A Randomized Trial.

BACKGROUND: A health department survey revealed nearly half employ laboratory-based HIV and HCV testing (LBT) over rapid testing (RT) in nonhospital settings such as drug detoxification centers. LBT has higher sensitivity for acute HIV infection compared to RT but LBT is not point of care and may result in fewer diagnoses due to loss to follow-up before result delivery. METHODS: We conducted a randomized trial comparing real-world case notification of RT (Orasure) vs LBT (HIV Combo Ag/Ab EIA, HCV EIA) for HIV and HCV at a drug detoxification center. Primary outcome was receipt of test results within 2 weeks. RESULTS: Among 341 individuals screened (11/2016-7/2017), 200 met inclusion criteria; 58% injected drugs and 31% shared needles in the previous 6 months. Of the 200 randomized, 98 received RT and 102 LBT. Among all participants, 0.5% were positive for HIV and 48% for HCV; 96% received test results in the RT arm and 42% in the LBT arm (odds ratio, 28.72; 95% confidence interval, 10.27-80.31). Real-world case notification was 95% and 93% for HIV and HCV RT, respectively, compared to 42% for HIV and HCV LBT. CONCLUSIONS: RT has higher real-world case notification than LBT at drug detoxification centers.Clinical trials registration: NCT02869776.