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Rationale C-reactive protein (CRP) has demonstrated utility as a point-of-care triage test for tuberculosis (TB) in clinical settings, particularly among people with HIV, but its performance for general-population TB screening is not well characterized. Objective To assess the accuracy of CRP for detecting pulmonary TB disease among individuals undergoing community-based screening or presenting for evaluation of TB symptoms in Kampala, Uganda. Methods We pooled data from two case-control studies conducted between May 2018 and December 2022 among adolescents and adults (>15 years) in Kampala, Uganda. We conducted community-based screening for TB, regardless of symptoms. We enrolled people with Xpert MTB/RIF Ultra-positive (including trace) sputum results and a sample of people with Ultra-negative results. We also enrolled symptomatic patients diagnosed with TB and controls with negative TB evaluations from ambulatory care settings. Participants underwent further evaluation including sputum culture, CRP and HIV testing. We assessed accuracy of CRP alone or with symptom screening, against a bacteriologic reference standard. Our primary analysis evaluated the sensitivity and specificity of CRP at a cutoff of 5 mg/L. Diagnostic performance was summarized by calculating area under the receiver operating curve (AUC). Results In the community setting (N=544), CRP ≥5mg/L had a sensitivity of 55.3% (95% confidence interval: 47.0-63.4) and specificity of 84.7% (79.7-88.8) for confirmed TB; AUC was 0.75 (0.70-0.79). Screening for CRP >5 mg/L or positive symptoms increased sensitivity to 92.0% (86.4-95.8) at the expense of specificity (57.1% [50.8-63.2]). In the ambulatory care setting (N=944), sensitivity of CRP >5 mg/L was 86.7% (81.8-90.7), specificity was 68.6% (64.8-72.2), and AUC (0.84 [0.81-0.87]) did not differ significantly by HIV status. CRP >5 mg/L was >90% sensitive among individuals with a medium or high semiquantitative Xpert result in both settings. Conclusions While CRP did not meet WHO TB screening benchmarks in the community, it demonstrated high specificity, and sensitivity was high among individuals with high sputum bacillary burden who are likely to be most infectious. In ambulatory care, estimated sensitivity and specificity were each within four percentage points of WHO benchmarks with no meaningful difference in performance by HIV status. Primary Source of Funding NIH R01HL138728, R01HL153611.
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BACKGROUND: "Trace" results on Xpert MTB/RIF Ultra ("Ultra") - a molecular diagnostic test for tuberculosis (TB) - are often interpreted as an indication for TB treatment, but may also represent detection of nonviable bacilli or analytical error. In community screening settings where individual TB risk is low, there is limited guidance on how to interpret Ultra-trace results. METHODS: We conducted systematic Ultra TB screening of adults and adolescents (≥15 years) in Kampala, Uganda through door-to-door and event-based sputum collection. We enrolled individuals with trace-positive sputum for detailed clinical, radiographic, and microbiological (including two sputum cultures, repeat Ultra, and for people with HIV, urine lipoarabinomannan) evaluation, and compared those findings to similar evaluations in controls with Ultra-negative and Ultra-positive (non-trace) sputum. RESULTS: Of 21,957 people screened with Ultra, 211 (1.0%) tested positive, including 96 (46% of positives) with trace results. Of 92 people enrolled with trace-positive sputum; 12% (11/92) were HIV-positive and 14% (13/92) had prior TB. The prevalence of TB among participants with trace-positive sputum results was 14% (13/92) by culture, 24% (22/92) using broader microbiological criteria, and 26% (24/92) after accounting for clinical diagnosis. The prevalence of cough and of abnormal chest CT findings were 32% and 26%, respectively, if Ultra-negative; 34% and 54% if trace-positive/non-microbiologically confirmed; 71% and 95% if trace-positive/microbiologically confirmed; and 72% and 92% if Ultra-positive (more than trace). CONCLUSION: Most individuals with trace-positive sputum in Ugandan communities did not have microbiologically confirmed TB but had more symptoms and chest CT abnormalities than people with Ultra-negative sputum.
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BACKGROUND: Despite the development and enforcement of preventive guidelines by governments, COVID-19 continues to spread across nations, causing unprecedented economic losses and mortality. Public places remain hotspots for COVID-19 transmission due to large numbers of people present; however preventive measures are poorly enforced. Supermarkets are among the high-risk establishments due to the high interactions involved, which makes compliance with the COVID-19 preventive guidelines of paramount importance. However, until now, there has been limited evidence on compliance with the set COVID-19 prevention guidelines. Therefore, this study aimed to measure compliance with the COVID-19 prevention guidelines among supermarkets in Kampala Capital City and Mukono Municipality Uganda. METHODS: A cross-sectional study was conducted among selected supermarkets in Kampala Capital City and Mukono Municipality in September 2020. A total of 229 supermarkets (195 in Kampala City and 34 in Mukono Municipality) were randomly selected for the study. Data were collected through structured observations on the status of compliance with COVID-19 prevention guidelines, and entered using the KoboCollect software, which was preinstalled on mobile devices (smart phones and tablets). Descriptive statistics were generated to measure compliance to the set COVID-19 Ministry of Health prevention guidelines using Stata 14 software. RESULTS: Only 16.6% (38/229) of the supermarkets complied with the COVID-19 prevention and control guidelines. In line with the specific measures, almost all supermarkets 95.2% (218/229) had hand washing facilities placed at strategic points such as the entrance, and 59.8% (137/229) of the supermarkets surveyed regularly disinfected commonly touched surfaces. Only 40.6% and 30.6% of the supermarkets enforced mandatory hand washing and use of face masks respectively for all customers accessing the premises. Slightly more than half, 52.4% (120/229) of the supermarkets had someone or a team in charge of enforcing compliance to COVID-19 measures and more than half, 55.5% (127/229) of the supermarkets had not provided their staff with job-specific training/mentorship on infection prevention and control for COVID-19. Less than a third, 26.2% (60/229) of the supermarkets had an infrared temperature gun for screening every customer, and only 5.7% (13/229) of the supermarkets captured details of clients accessing the supermarket as a measure to ease follow-up. CONCLUSION: This study revealed low compliance with COVID-19 guidelines, which required mandatory preventive measures such as face masking, regular disinfection, social distancing, and hand hygiene. This study suggests the need for health authorities to strengthen enforcement of these guidelines, and to sensitise the supermarket managers on COVID-19 in order to increase the uptake of the different measures.