BACKGROUND AND OBJECTIVES: Many neonatal intensive care units (NICUs) do not give rotavirus vaccines to inpatients due to a theoretical risk of horizontal transmission of vaccine strains. We aimed to determine incidence and clinical significance of vaccine-strain transmission to unvaccinated infants in a NICU that routinely administers pentavalent rotavirus vaccine (RV5). METHODS: This prospective cohort study included all patients admitted to a 100-bed NICU for 1 year. Stool specimens were collected weekly; real-time quantitative reverse-transcription polymerase chain reaction was used to detect any RV5 strain. Incidence of transmission to unvaccinated infants was calculated assuming each unvaccinated patient's stool contributed 1 patient-day at risk for transmission. Investigations and geospatial analyses were conducted for suspected transmission events. RESULTS: Of 1238 infants admitted, 560 (45%) were premature and 322 (26%) had gastrointestinal pathology. During observation, 226 RV5 doses were administered. Overall, 3448 stool samples were tested, including 2252 from 686 unvaccinated patients. Most (681, 99.3%) unvaccinated patients never tested positive for RV5 strain. Five (<1%) tested RV5 strain positive. The estimated rate of transmission to unvaccinated infants was 5/2252 stools or 2.2/1000 patient-days at risk (95% CI: 0.7-5.2). No gastroenteritis symptoms were identified in transmission cases within 7 days of collection of RV5-positive stool. Of 126 patients for whom the RV5 series was initiated before the discharge date, 55% would have become age-ineligible to start the series if vaccination was allowed only at discharge. CONCLUSIONS: Transmission of RV5 strain was infrequent and without clinical consequences. Benefits of allowing vaccine-induced protection against rotavirus disease in infants through in-NICU RV5 vaccination appear to have outweighed risks from vaccine-strain transmission.

BACKGROUND: Real-time PCR is recommended to detect SARS-CoV-2 infection. However, PCR availability is restricted in most countries. Rapid diagnostic tests are considered acceptable alternatives, but data are lacking on their performance. We assessed the performance of four antibody-based rapid diagnostic tests and one antigen-based rapid diagnostic test for detecting SARS-CoV-2 infection in the community in Cameroon. METHODS: In this clinical, prospective, diagnostic accuracy study, we enrolled individuals aged at least 21 years who were either symptomatic and suspected of having COVID-19 or asymptomatic and presented for screening. We tested peripheral blood for SARS-CoV-2 antibodies using the Innovita (Biological Technology; Beijing, China), Wondfo (Guangzhou Wondfo Biotech; Guangzhou, China), SD Biosensor (SD Biosensor; Gyeonggi-do, South Korea), and Runkun tests (Runkun Pharmaceutical; Hunan, China), and nasopharyngeal swabs for SARS-CoV-2 antigen using the SD Biosensor test. Antigen rapid diagnostic tests were compared with Abbott PCR testing (Abbott; Abbott Park, IL, USA), and antibody rapid diagnostic tests were compared with Biomerieux immunoassays (Biomerieux; Marcy l'Etoile, France). We retrospectively tested two diagnostic algorithms that incorporated rapid diagnostic tests for symptomatic and asymptomatic patients using simulation modelling. FINDINGS: 1195 participants were enrolled in the study. 347 (29%) tested SARS-CoV-2 PCR-positive, 223 (19%) rapid diagnostic test antigen-positive, and 478 (40%) rapid diagnostic test antibody-positive. Antigen-based rapid diagnostic test sensitivity was 80·0% (95% CI 71·0-88·0) in the first 7 days after symptom onset, but antibody-based rapid diagnostic tests had only 26·8% sensitivity (18·3-36·8). Antibody rapid diagnostic test sensitivity increased to 76·4% (70·1-82·0) 14 days after symptom onset. Among asymptomatic participants, the sensitivity of antigen-based and antibody-based rapid diagnostic tests were 37·0% (27·0-48·0) and 50·7% (42·2-59·1), respectively. Cohen's κ showed substantial agreement between Wondfo antibody rapid diagnostic test and gold-standard ELISA (κ=0·76; sensitivity 0·98) and between Biosensor and ELISA (κ=0·60; sensitivity 0·94). Innovita (κ=0·47; sensitivity 0·93) and Runkun (κ=0·43; sensitivity 0·76) showed moderate agreement. An antigen-based retrospective algorithm applied to symptomatic patients showed 94·0% sensitivity and 91·0% specificity in the first 7 days after symptom onset. For asymptomatic participants, the algorithm showed a sensitivity of 34% (95% CI 23·0-44·0) and a specificity of 92·0% (88·0-96·0). INTERPRETATION: Rapid diagnostic tests had good overall sensitivity for diagnosing SARS-CoV-2 infection. Rapid diagnostic tests could be incorporated into efficient testing algorithms as an alternative to PCR to decrease diagnostic delays and onward viral transmission. FUNDING: Médecins Sans Frontières WACA and Médecins Sans Frontières OCG. TRANSLATIONS: For the French and Spanish translations of the abstract see Supplementary Materials section.