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PurposeIn April 2020, the UK Government implemented NHS Test and Trace to provide SARS-CoV-2 quantitative reverse transcription polymerase chain reaction (qRT-PCR) testing for the public, with nose-and-throat swabbing for samples performed by trained staff. Self-swabbing (SS) would allow rapid scale-up of testing capacity and access. Six studies were undertaken to determine whether SS was as effective for detecting SARS-CoV-2 as swabbing performed by trained staff.MethodsSix prospective studies were conducted between April–October 2020, using six swab/media combinations. Differences between assisted swabbing (AS) and SS were evaluated for concordance, positivity, sensitivity, cycle threshold (Ct) values and void rates. Statistical analysis was performed using 95% confidence intervals (CIs), paired t-tests and model-based methods.ResultsOverall, 3,253 individuals were recruited (median age 37 years, 49% female), with 2,933 having valid paired qRT-PCR results. Pooled concordance rate was 98% (95% CI: 96%, 99%). Positivity rate differences for SS (8.1%) and AS (8.4%) and differences in pooled sensitivities between SS (86%; 95% CI: 78%, 92%) and AS (91%; 95% CI: 78%, 96%) were nonsignificant. Both types of swabbing led to pooled void rates below 2% and strongly correlated Ct values. Age, sex and previous swabbing experience did not have a significant impact on concordance or sensitivity.ConclusionThe UK adopted a policy to promote self-testing for SARS-CoV-2 based on data demonstrating equivalence of SS versus AS. Positive outcomes with SS are likely generalisable to testing for other respiratory pathogens, and we consider self-sampling and self-testing essential for future pandemic preparedness.

To detect SARS-CoV-2 amongst asymptomatic care home staff in England, a dual-technology weekly testing regime was introduced on 23 December 2020. A lateral flow device (LFD) and quantitative reverse transcription polymerase chain reaction (qRT-PCR) test were taken on the same day (day 0) and a midweek LFD test was taken three to four days later. We evaluated the effectiveness of using dual-technology to detect SARS-CoV-2 between December 2020 to April 2021. Viral concentrations derived from qRT-PCR were used to determine the probable stage of infection and likely level of infectiousness. Day 0 PCR detected 1,493 cases of COVID-19, of which 53% were in the early stages of infection with little to no risk of transmission. Day 0 LFD detected 83% of cases that were highly likely to be infectious. On average, LFD results were received 46.3 h earlier than PCR, enabling removal of likely infectious staff from the workplace quicker than by weekly PCR alone. Demonstrating the rapidity of LFDs to detect highly infectious cases could be combined with the ability of PCR to detect cases in the very early stages of infection. In practice, asymptomatic care home staff were removed from the workplace earlier, breaking potential chains of transmission.

Background Covid-19 healthcare worker testing, isolation and quarantine policies had to balance risks to patients from the virus and from staff absence. The emergence of the Omicron variant led to dangerous levels of key-worker absence globally. We evaluated whether using two manufacturers’ lateral flow tests (LFTs) concurrently improved SARS-CoV-2 Omicron detection significantly and was acceptable to hospital staff. In a nested study, to understand risks of return to work after a 5-day isolation/quarantine period, we examined virus culture 5–7 days after positive test or significant exposure. Methods Fully-vaccinated Liverpool (UK) University Hospitals staff participated (February-May 2022) in a random-order, open-label trial testing whether dual LFTs improved SARS-CoV-2 detection, and whether dual swabbing was acceptable to users. Participants used nose-throat swab Innova and nose-only swab Orient Gene LFTs in daily randomised order for 10 days. A user-experience questionnaire was administered on exit. Selected participants gave swabs for viral culture on days 5–7 after symptom onset or first positive test. Cultures were considered positive if cytopathic effect was apparent or SARS-CoV-2 N gene sub-genomic RNA was detected. Results Two hundred and twenty-six individuals reported 1466 pairs of LFT results. Tests disagreed in 127 cases (8.7%). Orient Gene was more likely (78 cf. 49; OR: 2.1, 1.1–4.1; P  = 0.03) to be positive. If Innova was swabbed second, it was less likely to agree with a positive Orient Gene result (OR: 2.7, 1.3–5.2; P  = 0.005); swabbing first with Innova made no significant difference (OR: 1.1, 0.5–2.3; P  = 0.85). Orient Gene positive Innova negative result-pairs became more frequent over time (OR: 1.2, 1.1–1.3; P  < 0.001). Of individuals completing the exit questionnaire, 90.7% reported dual swabbing was easy, 57.1% said it was no barrier to their daily routine and 65.6% preferred dual testing. Respondents had more confidence in dual versus single test results. Viral cultures from days 5–7 were positive for 6/31 (19.4%, 7.5%-37.5%) and indeterminate for 11/31 (35.5%, 19.2%-54.6%) LFT-positive participants, indicating they were likely still infectious. Conclusions Dual brand testing increased LFT detection of SARS-CoV-2 antigen by a small but meaningful margin and was acceptable to hospital workers. Viral cultures demonstrated that policies recommending safe return to work ~ 5 days after Omicron infection/exposure were flawed. Key-workers should be prepared for dynamic self-testing protocols in future pandemics. Trial registration https://www.isrctn.com/ISRCTN47058442 (26 January 2022).

In 2009, the English Department of Health appointed 16 integrated care pilots which aimed to provide better integrated care. We report the quantitative results from a multi-method evaluation of six of the demonstration projects which used risk profiling tools to identify older people at risk of emergency hospital admission, combined with intensive case management for people identified as at risk. The interventions focused mainly on delivery system redesign and improved clinical information systems, two key elements of Wagner's Chronic Care Model. Questionnaires to staff and patients. Difference-in-differences analysis of secondary care utilisation using data on 3646 patients and 17,311 matched controls, and changes in overall secondary care utilisation. Most staff thought that care for their patients had improved. More patients reported having a care plan but they found it significantly harder to see a doctor or nurse of their choice and felt less involved in decisions about their care. Case management interventions were associated with a 9% increase in emergency admissions. We found some evidence of imbalance between cases and controls which could have biased this estimate, but simulations of the possible effect of unobserved confounders showed that it was very unlikely that the sites achieved their goal of reducing emergency admissions. However, we found significant reductions of 21% and 22% in elective admissions and outpatient attendance in the six months following an intervention, and overall inpatient and outpatient costs were significantly reduced by 9% during this period. Area level analyses of whole practice populations suggested that overall outpatient attendances were significantly reduced by 5% two years after the start of the case management schemes. Case management may result in improvements in some aspects of care and has the potential to reduce secondary care costs. However, to improve patient experience, case management approaches need to be introduced in a way which respects patients' wishes, for example the ability to see a familiar doctor or nurse.

School-based COVID-19 contacts in England have been asked to self-isolate at home, missing key educational opportunities. We trialled daily testing of contacts as an alternative to assess whether this resulted in similar control of transmission, while allowing more school attendance. We did an open-label, cluster-randomised, controlled trial in secondary schools and further education colleges in England. Schools were randomly assigned (1:1) to self-isolation of school-based COVID-19 contacts for 10 days (control) or to voluntary daily lateral flow device (LFD) testing for 7 days with LFD-negative contacts remaining at school (intervention). Randomisation was stratified according to school type and size, presence of a sixth form, presence of residential students, and proportion of students eligible for free school meals. Group assignment was not masked during procedures or analysis. Coprimary outcomes in all students and staff were COVID-19-related school absence and symptomatic PCR-confirmed COVID-19, adjusted for community case rates, to estimate within-school transmission (non-inferiority margin <50% relative increase). Analyses were done on an intention-to-treat basis using quasi-Poisson regression, also estimating complier average causal effects (CACE). This trial is registered with the ISRCTN registry, ISRCTN18100261. Between March 18 and May 4, 2021, 204 schools were taken through the consent process, during which three decided not to participate further. 201 schools were randomly assigned (control group n=99, intervention group n=102) in the 10-week study (April 19–May 10, 2021), which continued until the pre-appointed stop date (June 27, 2021). 76 control group schools and 86 intervention group schools actively participated; additional national data allowed most non-participating schools to be included in analysis of coprimary outcomes. 2432 (42·4%) of 5763 intervention group contacts participated in daily contact testing. There were 657 symptomatic PCR-confirmed infections during 7 782 537 days-at-risk (59·1 per 100 000 per week) in the control group and 740 during 8 379 749 days-at-risk (61·8 per 100 000 per week) in the intervention group (intention-to-treat adjusted incidence rate ratio [aIRR] 0·96 [95% CI 0·75–1·22]; p=0·72; CACE aIRR 0·86 [0·55–1·34]). Among students and staff, there were 59 422 (1·62%) COVID-19-related absences during 3 659 017 person-school-days in the control group and 51 541 (1·34%) during 3 845 208 person-school-days in the intervention group (intention-to-treat aIRR 0·80 [95% CI 0·54–1·19]; p=0·27; CACE aIRR 0·61 [0·30–1·23]). Daily contact testing of school-based contacts was non-inferior to self-isolation for control of COVID-19 transmission, with similar rates of symptomatic infections among students and staff with both approaches. Infection rates in school-based contacts were low, with very few school contacts testing positive. Daily contact testing should be considered for implementation as a safe alternative to home isolation following school-based exposures. UK Government Department of Health and Social Care.

Antigen lateral flow devices (LFDs) have been widely used to control SARS-CoV-2. We aimed to improve understanding of LFD performance with changes in variant infections, vaccination, viral load, and LFD use, and in the detection of infectious individuals. In this diagnostic study, paired LFD and RT-PCR test results were prospectively collected from asymptomatic and symptomatic participants in the UK between Nov 4, 2020, and March 21, 2022, to support the National Health Service (NHS) England's Test and Trace programme. The LFDs evaluated were the Innova SARS-CoV-2 Antigen Rapid Qualitative Test, the Orient Gene Rapid Covid-19 (Antigen) Self-Test, and the Acon Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). Test results were collected across various community testing settings, including predeployment testing sites, routine testing centres, homes, schools, universities, workplaces, targeted community testing, and from health-care workers. We used multivariable logistic regression to analyse LFD sensitivity and specificity using RT-PCR as a reference standard, adjusting for viral load, LFD manufacturer, test setting, age, sex, test assistance, symptom status, vaccination status, and SARS-CoV-2 variant. National contact tracing data from NHS Test and Trace (Jan 1, 2021, to Jan 11, 2022) were used to estimate the proportion of transmitting index patients (with ≥1 RT-PCR-positive or LFD-positive contact) potentially detectable by LFDs (specifically Innova, as the most widely used LFD) with time, accounting for index viral load, variant, and symptom status. We assessed 75 382 pairs of LFD and RT-PCR tests. Of these, 4131 (5·5%) were RT-PCR-positive. LFD sensitivity versus RT-PCR was 63·2% (95% CI 61·7–64·6) and specificity was 99·71% (95% CI 99·66–99·74). Increased viral load was independently associated with being LFD positive (adjusted odds ratio [aOR] 2·85 [95% CI 2·66–3·06] per 1 log10 copies per mL increase; p<0·0001). There was no evidence that LFD sensitivity differed for delta (B.1.617.2) infections versus alpha (B.1.1.7) or pre-alpha (B.1.177) infections (aOR 1·00 [0·69–1·45]; p=0·99), whereas omicron (BA.1 or BA.2) infections appeared more likely to be LFD positive (aOR 1·63 [1·02–2·59]; p=0·042). Sensitivity was higher in symptomatic participants (68·7% [95% CI 66·9–70·4]) than in asymptomatic participants (52·8% [50·1–55·4]). Among 347 374 unique index patients with probable onward transmission, 78·3% (95% CI 75·3–81·2) were estimated to have been detectable with LFDs (Innova), and this proportion was mostly stable with time and for successive variants. Overall, the estimated proportion of infectious index patients detectable by the Innova LFD was lower in asymptomatic patients (57·6% [53·6–61·9]) versus symptomatic patients (79·7% [76·7–82·5]). LFDs remained able to detect most SARS-CoV-2 infections throughout vaccine roll-out and across different viral variants. LFDs can potentially detect most infections that transmit to others and reduce the risk of transmission. However, performance is lower in asymptomatic individuals than in symptomatic individuals. UK Health Security Agency, the UK Government Department of Health and Social Care, National Institute for Health Research (NIHR) Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, and the University of Oxford NIHR Biomedical Research Centre.

BackgroundRapid identification of individuals with acute respiratory infections is crucial for preventing nosocomial infections. For rapid diagnosis, especially in EDs, lateral flow devices (LFDs) are a convenient, inexpensive option with a rapid turnaround. Several ‘multiplex’ LFDs (M-LFDs) now exist, testing for multiple pathogens from a single swab sample. We evaluated the real-world performance of M-LFD versus PCR testing in detecting influenza A, B and SARS-CoV-2) in the ED setting.MethodsAfter preliminary evaluation of an M-LFD (SureScreen) with laboratory-grown virus and PCR-negative clinical samples, it was evaluated in a real-world setting at the ED of St Thomas’ Hospital (London, UK) from 1 December 2022 to 21 April 2023. Eligible participants were ≥18 years of age, admitted with respiratory symptoms and received concurrent M-LFD and PCR tests. Main endpoints were sensitivity to detect influenza A/B (primary) and SARS-CoV-2 (secondary) versus PCR. The probability of a true positive in relation to viral concentration (expressed as PCR cycle threshold (Ct)) was analysed using logistic regression.ResultsIn total, 808 symptomatic participants were included (49.8% female; mean age 46.9 years). Test sensitivity (95% CI) was 67.0% (56.9% to 76.1%) for influenza A (n=100), 94.1% (71.3% to 99.9%) for influenza B (n=17) and 48.2% (39.7% to 56.8%) for SARS-CoV-2 (n=141). Sensitivity for SARS-CoV-2 was significantly lower than that for influenza A and B (p=0.0057 and p=0.00088, respectively). The probability of a true positive was 98% for Ct<25 for influenza A and SARS-CoV-2 (influenza B non-evaluable). No co-infections were identified by PCR or M-LFD.ConclusionThe real-world performance of SureScreen M-LFD was consistent with laboratory evaluation and achieved a high sensitivity for individuals with high viral concentration, most likely to be infectious. Given the representative UK population sample, results could be generalised for use in other settings.

Objectives To test the effect of a telephone health coaching service (Birmingham OwnHealth) on hospital use and associated costs. Design Analysis of person level administrative data. Difference-in-difference analysis was done relative to matched controls. Setting Community based intervention operating in a large English city with industry. Participants 2698 patients recruited from local general practices before 2009 with heart failure, coronary heart disease, diabetes, or chronic obstructive pulmonary disease; and a history of inpatient or outpatient hospital use. These individuals were matched on a 1:1 basis to control patients from similar areas of England with respect to demographics, diagnoses of health conditions, previous hospital use, and a predictive risk score. Intervention Telephone health coaching involved a personalised care plan and a series of outbound calls usually scheduled monthly. Median length of time enrolled on the service was 25.5 months. Control participants received usual healthcare in their areas, which did not include telephone health coaching. Main outcome measures Number of emergency hospital admissions per head over 12 months after enrolment. Secondary metrics calculated over 12 months were: hospital bed days, elective hospital admissions, outpatient attendances, and secondary care costs. Results In relation to diagnoses of health conditions and other baseline variables, matched controls and intervention patients were similar before the date of enrolment. After this point, emergency admissions increased more quickly among intervention participants than matched controls (difference 0.05 admissions per head, 95% confidence interval 0.00 to 0.09, P=0.046). Outpatient attendances also increased more quickly in the intervention group (difference 0.37 attendances per head, 0.16 to 0.58, P<0.001), as did secondary care costs (difference £175 per head, £22 to £328, P=0.025). Checks showed that we were unlikely to have missed reductions in emergency admissions because of unobserved differences between intervention and matched control groups. Conclusions The Birmingham OwnHealth telephone health coaching intervention did not lead to the expected reductions in hospital admissions or secondary care costs over 12 months, and could have led to increases.

Introduction: In 2009, the English Department of Health appointed 16 integrated care pilots which aimed to provide better integrated care. We report the quantitative results from a multi-method evaluation of six of the demonstration projects which used risk profiling tools to identify older people at risk of emergency hospital admission, combined with intensive case management for people identified as at risk. The interventions focused mainly on delivery system redesign and improved clinical information systems, two key elements of Wagner's Chronic Care Model. Methods: Questionnaires to staff and patients. Difference-in-differences analysis of secondary care utilisation using data on 3,646 patients and 17,311 matched controls, and changes in overall secondary care utilisation. Results: Most staff thought that care for their patients had improved. More patients reported having a care plan but they found it significantly harder to see a doctor or nurse of their choice and felt less involved in decisions about their care. Case management interventions were associated with a 9% increase in emergency admissions. We found some evidence of imbalance between cases and controls which could have biased this estimate, but simulations of the possible effect of unobserved confounders showed that it was very unlikely that the sites achieved their goal of reducing emergency admissions. However, we found significant reductions of 21% and 22% in elective admissions and outpatient attendance in the six months following an intervention, and overall inpatient and outpatient costs were significantly reduced by 9% during this period. Area level analyses of whole practice populations suggested that overall outpatient attendances were significantly reduced by 5% two years after the start of the case management schemes. Conclusion: Case management may result in improvements in some aspects of care and has the potential to reduce secondary care costs. However, to improve patient experience, case management approaches need to be introduced in a way which respects patients' wishes, for example the ability to see a familiar doctor or nurse.