Diagnostic and prognostic research最新文献

{"title":"An external validation of the Kidney Donor Risk Index in the UK transplant population in the presence of semi-competing events.","authors":"Stephanie Riley, Kimberly Tam, Wai-Yee Tse, Andrew Connor, Yinghui Wei","doi":"10.1186/s41512-023-00159-9","DOIUrl":"10.1186/s41512-023-00159-9","url":null,"abstract":"<p><strong>Background: </strong>Transplantation represents the optimal treatment for many patients with end-stage kidney disease. When a donor kidney is available to a waitlisted patient, clinicians responsible for the care of the potential recipient must make the decision to accept or decline the offer based upon complex and variable information about the donor, the recipient and the transplant process. A clinical prediction model may be able to support clinicians in their decision-making. The Kidney Donor Risk Index (KDRI) was developed in the United States to predict graft failure following kidney transplantation. The survival process following transplantation consists of semi-competing events where death precludes graft failure, but not vice-versa.</p><p><strong>Methods: </strong>We externally validated the KDRI in the UK kidney transplant population and assessed whether validation under a semi-competing risks framework impacted predictive performance. Additionally, we explored whether the KDRI requires updating. We included 20,035 adult recipients of first, deceased donor, single, kidney-only transplants between January 1, 2004, and December 31, 2018, collected by the UK Transplant Registry and held by NHS Blood and Transplant. The outcomes of interest were 1- and 5-year graft failure following transplantation. In light of the semi-competing events, recipient death was handled in two ways: censoring patients at the time of death and modelling death as a competing event. Cox proportional hazard models were used to validate the KDRI when censoring graft failure by death, and cause-specific Cox models were used to account for death as a competing event.</p><p><strong>Results: </strong>The KDRI underestimated event probabilities for those at higher risk of graft failure. For 5-year graft failure, discrimination was poorer in the semi-competing risks model (0.625, 95% CI 0.611 to 0.640;0.611, 95% CI 0.597 to 0.625), but predictions were more accurate (Brier score 0.117, 95% CI 0.112 to 0.121; 0.114, 95% CI 0.109 to 0.118). Calibration plots were similar regardless of whether the death was modelled as a competing event or not. Updating the KDRI worsened calibration, but marginally improved discrimination.</p><p><strong>Conclusions: </strong>Predictive performance for 1-year graft failure was similar between death-censored and competing event graft failure, but differences appeared when predicting 5-year graft failure. The updated index did not have superior performance and we conclude that updating the KDRI in the present form is not required.</p>","PeriodicalId":72800,"journal":{"name":"Diagnostic and prognostic research","volume":"7 1","pages":"20"},"PeriodicalIF":0.0,"publicationDate":"2023-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10662562/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138178176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and internal validation of a model predicting patient-reported shoulder function after arthroscopic rotator cuff repair in a Swiss setting.","authors":"Thomas Stojanov, Soheila Aghlmandi, Andreas Marc Müller, Markus Scheibel, Matthias Flury, Laurent Audigé","doi":"10.1186/s41512-023-00156-y","DOIUrl":"10.1186/s41512-023-00156-y","url":null,"abstract":"<p><strong>Background: </strong>Prediction models for outcomes after orthopedic surgery provide patients with evidence-based postoperative outcome expectations. Our objectives were (1) to identify prognostic factors associated with the postoperative shoulder function outcome (the Oxford Shoulder Score (OSS)) and (2) to develop and validate a prediction model for postoperative OSS.</p><p><strong>Methods: </strong>Patients undergoing arthroscopic rotator cuff repair (ARCR) were prospectively documented at a Swiss orthopedic tertiary care center. The first primary ARCR in adult patients with a partial or complete rotator cuff tear were included between October 2013 and June 2021. Thirty-two potential prognostic factors were used for prediction model development. Two sets of factors identified using the knowledge from three experienced surgeons (Set 1) and Bayesian projection predictive variable selection (Set 2) were compared in terms of model performance using R squared and root-mean-squared error (RMSE) across 45 multiple imputed data sets using chained equations and complete case data.</p><p><strong>Results: </strong>Multiple imputation using data from 1510 patients was performed. Set 2 retained the following factors: American Society of Anesthesiologists (ASA) classification, baseline level of depression and anxiety, baseline OSS, operation duration, tear severity, and biceps status and treatment. Apparent model performance was R-squared = 0.174 and RMSE = 7.514, dropping to R-squared = 0.156, and RMSE = 7.603 after correction for optimism.</p><p><strong>Conclusion: </strong>A prediction model for patients undergoing ARCR was developed using solely baseline and operative data in order to provide patients and surgeons with individualized expectations for postoperative shoulder function outcomes. Yet, model performance should be improved before being used in clinical routine.</p>","PeriodicalId":72800,"journal":{"name":"Diagnostic and prognostic research","volume":"7 1","pages":"21"},"PeriodicalIF":0.0,"publicationDate":"2023-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10629040/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71489635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Using the kidney failure risk equation to predict end-stage kidney disease in CKD patients of South Asian ethnicity: an external validation study.","authors":"Francesca Maher, Lucy Teece, Rupert W Major, Naomi Bradbury, James F Medcalf, Nigel J Brunskill, Sarah Booth, Laura J Gray","doi":"10.1186/s41512-023-00157-x","DOIUrl":"10.1186/s41512-023-00157-x","url":null,"abstract":"<p><strong>Background: </strong>The kidney failure risk equation (KFRE) predicts the 2- and 5-year risk of needing kidney replacement therapy (KRT) using four risk factors - age, sex, urine albumin-to-creatinine ratio (ACR) and creatinine-based estimated glomerular filtration rate (eGFR). Although the KFRE has been recalibrated in a UK cohort, this did not consider minority ethnic groups. Further validation of the KFRE in different ethnicities is a research priority. The KFRE also does not consider the competing risk of death, which may lead to overestimation of KRT risk. This study externally validates the KFRE for patients of South Asian ethnicity and compares methods for accounting for ethnicity and the competing event of death.</p><p><strong>Methods: </strong>Data were gathered from an established UK cohort containing 35,539 individuals diagnosed with chronic kidney disease. The KFRE was externally validated and updated in several ways taking into account ethnicity, using recognised methods for time-to-event data, including the competing risk of death. A clinical impact assessment compared the updated models through consideration of referrals made to secondary care.</p><p><strong>Results: </strong>The external validation showed the risk of KRT differed by ethnicity. Model validation performance improved when incorporating ethnicity and its interactions with ACR and eGFR as additional risk factors. Furthermore, accounting for the competing risk of death improved prediction. Using criteria of 5 years ≥ 5% predicted KRT risk, the competing risks model resulted in an extra 3 unnecessary referrals (0.59% increase) but identified an extra 1 KRT case (1.92% decrease) compared to the previous best model. Hybrid criteria of predicted risk using the competing risks model and ACR ≥ 70 mg/mmol should be used in referrals to secondary care.</p><p><strong>Conclusions: </strong>The accuracy of KFRE prediction improves when updated to consider South Asian ethnicity and to account for the competing risk of death. This may reduce unnecessary referrals whilst identifying risks of KRT and could further individualise the KFRE and improve its clinical utility. Further research should consider other ethnicities.</p>","PeriodicalId":72800,"journal":{"name":"Diagnostic and prognostic research","volume":"7 1","pages":"22"},"PeriodicalIF":0.0,"publicationDate":"2023-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10552237/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41159135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An enhanced version of FREM (Fracture Risk Evaluation Model) using national administrative health data: analysis protocol for development and validation of a multivariable prediction model.","authors":"Simon Bang Kristensen, Anne Clausen, Michael Kriegbaum Skjødt, Jens Søndergaard, Bo Abrahamsen, Sören Möller, Katrine Hass Rubin","doi":"10.1186/s41512-023-00158-w","DOIUrl":"10.1186/s41512-023-00158-w","url":null,"abstract":"<p><strong>Background: </strong>Osteoporosis poses a growing healthcare challenge owing to its rising prevalence and a significant treatment gap, as patients are widely underdiagnosed and consequently undertreated, leaving them at high risk of osteoporotic fracture. Several tools aim to improve case-finding in osteoporosis. One such tool is the Fracture Risk Evaluation Model (FREM), which in contrast to other tools focuses on imminent fracture risk and holds potential for automation as it relies solely on data that is routinely collected via the Danish healthcare registers. The present article is an analysis protocol for a prediction model that is to be used as a modified version of FREM, with the intention of improving the identification of subjects at high imminent risk of fracture by including pharmacological exposures and using more advanced statistical methods compared to the original FREM. Its main purposes are to document and motivate various aspects and choices of data management and statistical analyses.</p><p><strong>Methods: </strong>The model will be developed by employing logistic regression with grouped LASSO regularization as the primary statistical approach and gradient-boosted classification trees as a secondary statistical modality. Hyperparameter choices as well as computational considerations on these two approaches are investigated by an unsupervised data review (i.e., blinded to the outcome), which also investigates and handles multicollinarity among the included exposures. Further, we present an unsupervised review of the data and testing of analysis code with respect to speed and robustness on a remote analysis environment. The data review and code tests are used to adjust the analysis plans in a blinded manner, so as not to increase the risk of overfitting in the proposed methods.</p><p><strong>Discussion: </strong>This protocol specifies the planned tool development to ensure transparency in the modeling approach, hence improving the validity of the enhanced tool to be developed. Through an unsupervised data review, it is further documented that the planned statistical approaches are feasible and compatible with the data employed.</p>","PeriodicalId":72800,"journal":{"name":"Diagnostic and prognostic research","volume":"7 1","pages":"19"},"PeriodicalIF":0.0,"publicationDate":"2023-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10546772/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41123449","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study design for development of novel safety biomarkers of drug-induced liver injury by the translational safety biomarker pipeline (TransBioLine) consortium: a study protocol for a nested case-control study.","authors":"Jane I Grove, Camilla Stephens, M Isabel Lucena, Raúl J Andrade, Sabine Weber, Alexander Gerbes, Einar S Bjornsson, Guido Stirnimann, Ann K Daly, Matthias Hackl, Kseniya Khamina-Kotisch, Jose J G Marin, Maria J Monte, Sara A Paciga, Melanie Lingaya, Shiva S Forootan, Christopher E P Goldring, Oliver Poetz, Rudolf Lombaard, Alexandra Stege, Helgi K Bjorrnsson, Mercedes Robles-Diaz, Dingzhou Li, Thi Dong Binh Tran, Shashi K Ramaiah, Sophia L Samodelov, Gerd A Kullak-Ublick, Guruprasad P Aithal","doi":"10.1186/s41512-023-00155-z","DOIUrl":"10.1186/s41512-023-00155-z","url":null,"abstract":"<p><p>A lack of biomarkers that detect drug-induced liver injury (DILI) accurately continues to hinder early- and late-stage drug development and remains a challenge in clinical practice. The Innovative Medicines Initiative's TransBioLine consortium comprising academic and industry partners is developing a prospective repository of deeply phenotyped cases and controls with biological samples during liver injury progression to facilitate biomarker discovery, evaluation, validation and qualification.In a nested case-control design, patients who meet one of these criteria, alanine transaminase (ALT) ≥ 5 × the upper limit of normal (ULN), alkaline phosphatase ≥ 2 × ULN or ALT ≥ 3 ULN with total bilirubin > 2 × ULN, are enrolled. After completed clinical investigations, Roussel Uclaf Causality Assessment and expert panel review are used to adjudicate episodes as DILI or alternative liver diseases (acute non-DILI controls). Two blood samples are taken: at recruitment and follow-up. Sample size is as follows: 300 cases of DILI and 130 acute non-DILI controls. Additional cross-sectional cohorts (1 visit) are as follows: Healthy volunteers (n = 120), controls with chronic alcohol-related or non-alcoholic fatty liver disease (n = 100 each) and patients with psoriasis or rheumatoid arthritis (n = 100, 50 treated with methotrexate) are enrolled. Candidate biomarkers prioritised for evaluation include osteopontin, glutamate dehydrogenase, cytokeratin-18 (full length and caspase cleaved), macrophage-colony-stimulating factor 1 receptor and high mobility group protein B1 as well as bile acids, sphingolipids and microRNAs. The TransBioLine project is enabling biomarker discovery and validation that could improve detection, diagnostic accuracy and prognostication of DILI in premarketing clinical trials and for clinical healthcare application.</p>","PeriodicalId":72800,"journal":{"name":"Diagnostic and prognostic research","volume":"7 1","pages":"18"},"PeriodicalIF":0.0,"publicationDate":"2023-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10496294/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10588098","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prognosis and prediction of antibiotic benefit in adults with clinically diagnosed acute rhinosinusitis: an individual participant data meta-analysis.","authors":"Jeroen Hoogland, Toshihiko Takada, Maarten van Smeden, Maroeska M Rovers, An I de Sutter, Daniel Merenstein, Laurent Kaiser, Helena Liira, Paul Little, Heiner C Bucher, Karel G M Moons, Johannes B Reitsma, Roderick P Venekamp","doi":"10.1186/s41512-023-00154-0","DOIUrl":"10.1186/s41512-023-00154-0","url":null,"abstract":"<p><strong>Background: </strong>A previous individual participant data meta-analysis (IPD-MA) of antibiotics for adults with clinically diagnosed acute rhinosinusitis (ARS) showed a marginal overall effect of antibiotics, but was unable to identify patients that are most likely to benefit from antibiotics when applying conventional (i.e. univariable or one-variable-at-a-time) subgroup analysis. We updated the systematic review and investigated whether multivariable prediction of patient-level prognosis and antibiotic treatment effect may lead to more tailored treatment assignment in adults presenting to primary care with ARS.</p><p><strong>Methods: </strong>An IPD-MA of nine double-blind placebo-controlled trials of antibiotic treatment (n=2539) was conducted, with the probability of being cured at 8-15 days as the primary outcome. A logistic mixed effects model was developed to predict the probability of being cured based on demographic characteristics, signs and symptoms, and antibiotic treatment assignment. Predictive performance was quantified based on internal-external cross-validation in terms of calibration and discrimination performance, overall model fit, and the accuracy of individual predictions.</p><p><strong>Results: </strong>Results indicate that the prognosis with respect to risk of cure could not be reliably predicted (c-statistic 0.58 and Brier score 0.24). Similarly, patient-level treatment effect predictions did not reliably distinguish between those that did and did not benefit from antibiotics (c-for-benefit 0.50).</p><p><strong>Conclusions: </strong>In conclusion, multivariable prediction based on patient demographics and common signs and symptoms did not reliably predict the patient-level probability of cure and antibiotic effect in this IPD-MA. Therefore, these characteristics cannot be expected to reliably distinguish those that do and do not benefit from antibiotics in adults presenting to primary care with ARS.</p>","PeriodicalId":72800,"journal":{"name":"Diagnostic and prognostic research","volume":"7 1","pages":"16"},"PeriodicalIF":0.0,"publicationDate":"2023-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10478354/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10168341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sample size determination for point-of-care COVID-19 diagnostic tests: a Bayesian approach.","authors":"S Faye Williamson, Cameron J Williams, B Clare Lendrem, Kevin J Wilson","doi":"10.1186/s41512-023-00153-1","DOIUrl":"10.1186/s41512-023-00153-1","url":null,"abstract":"<p><strong>Background: </strong>In a pandemic setting, it is critical to evaluate and deploy accurate diagnostic tests rapidly. This relies heavily on the sample size chosen to assess the test accuracy (e.g. sensitivity and specificity) during the diagnostic accuracy study. Too small a sample size will lead to imprecise estimates of the accuracy measures, whereas too large a sample size may delay the development process unnecessarily. This study considers use of a Bayesian method to guide sample size determination for diagnostic accuracy studies, with application to COVID-19 rapid viral detection tests. Specifically, we investigate whether utilising existing information (e.g. from preceding laboratory studies) within a Bayesian framework can reduce the required sample size, whilst maintaining test accuracy to the desired precision.</p><p><strong>Methods: </strong>The method presented is based on the Bayesian concept of assurance which, in this context, represents the unconditional probability that a diagnostic accuracy study yields sensitivity and/or specificity intervals with the desired precision. We conduct a simulation study to evaluate the performance of this approach in a variety of COVID-19 settings, and compare it to commonly used power-based methods. An accompanying interactive web application is available, which can be used by researchers to perform the sample size calculations.</p><p><strong>Results: </strong>Results show that the Bayesian assurance method can reduce the required sample size for COVID-19 diagnostic accuracy studies, compared to standard methods, by making better use of laboratory data, without loss of performance. Increasing the size of the laboratory study can further reduce the required sample size in the diagnostic accuracy study.</p><p><strong>Conclusions: </strong>The method considered in this paper is an important advancement for increasing the efficiency of the evidence development pathway. It has highlighted that the trade-off between lab study sample size and diagnostic accuracy study sample size should be carefully considered, since establishing an adequate lab sample size can bring longer-term gains. Although emphasis is on its use in the COVID-19 pandemic setting, where we envisage it will have the most impact, it can be usefully applied in other clinical areas.</p>","PeriodicalId":72800,"journal":{"name":"Diagnostic and prognostic research","volume":"7 1","pages":"17"},"PeriodicalIF":0.0,"publicationDate":"2023-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10436636/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10038806","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Basal procalcitonin, C-reactive protein, interleukin-6, and presepsin for prediction of mortality in critically ill septic patients: a systematic review and meta-analysis.","authors":"Daniel Molano-Franco, Ingrid Arevalo-Rodriguez, Alfonso Muriel, Laura Del Campo-Albendea, Silvia Fernández-García, Ana Alvarez-Méndez, Daniel Simancas-Racines, Andres Viteri, Guillermo Sanchez, Borja Fernandez-Felix, Jesus Lopez-Alcalde, Ivan Solà, Dimelza Osorio, Khalid Saeed Khan, Xavier Nuvials, Ricard Ferrer, Javier Zamora","doi":"10.1186/s41512-023-00152-2","DOIUrl":"10.1186/s41512-023-00152-2","url":null,"abstract":"<p><strong>Background: </strong>Numerous biomarkers have been proposed for diagnosis, therapeutic, and prognosis in sepsis. Previous evaluations of the value of biomarkers for predicting mortality due to this life-threatening condition fail to address the complexity of this condition and the risk of bias associated with prognostic studies. We evaluate the predictive performance of four of these biomarkers in the prognosis of mortality through a methodologically sound evaluation.</p><p><strong>Methods: </strong>We conducted a systematic review a systematic review and meta-analysis to determine, in critically ill adults with sepsis, whether procalcitonin (PCT), C-reactive protein (CRP), interleukin-6 (IL-6), and presepsin (sCD14) are independent prognostic factors for mortality. We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials up to March 2023. Only Phase-2 confirmatory prognostic factor studies among critically ill septic adults were included. Random effects meta-analyses pooled the prognostic association estimates.</p><p><strong>Results: </strong>We included 60 studies (15,681 patients) with 99 biomarker assessments. Quality of the statistical analysis and reporting domains using the QUIPS tool showed high risk of bias in > 60% assessments. The biomarker measurement as a continuous variable in models adjusted by key covariates (age and severity score) for predicting mortality at 28-30 days showed a null or near to null association for basal PCT (pooled OR = 0.99, 95% CI = 0.99-1.003), CRP (OR = 1.01, 95% CI = 0.87 to 1.17), and IL-6 (OR = 1.02, 95% CI = 1.01-1.03) and sCD14 (pooled HR = 1.003, 95% CI = 1.000 to 1.006). Additional meta-analyses accounting for other prognostic covariates had similarly null findings.</p><p><strong>Conclusion: </strong>Baseline, isolated measurement of PCT, CRP, IL-6, and sCD14 has not been shown to help predict mortality in critically ill patients with sepsis. The role of these biomarkers should be evaluated in new studies where the patient selection would be standardized and the measurement of biomarker results.</p><p><strong>Trial registration: </strong>PROSPERO (CRD42019128790).</p>","PeriodicalId":72800,"journal":{"name":"Diagnostic and prognostic research","volume":"7 1","pages":"15"},"PeriodicalIF":0.0,"publicationDate":"2023-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10399020/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9938887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Field evaluations of four SARS-CoV-2 rapid antigen tests during SARS-CoV-2 Delta variant wave in South Africa.","authors":"Natasha Samsunder, Gila Lustig, Slindile Ngubane, Thando Glory Maseko, Santhuri Rambaran, Sinaye Ngcapu, Stanley Nzuzo Magini, Lara Lewis, Cherie Cawood, Ayesha B M Kharsany, Quarraisha Abdool Karim, Salim Abdool Karim, Kogieleum Naidoo, Aida Sivro","doi":"10.1186/s41512-023-00151-3","DOIUrl":"10.1186/s41512-023-00151-3","url":null,"abstract":"<p><strong>Background: </strong>Rapid antigen tests detecting SARS-CoV-2 were shown to be a useful tool in managing the COVID-19 pandemic. Here, we report on the results of a prospective diagnostic accuracy study of four SARS-CoV-2 rapid antigen tests in a South African setting.</p><p><strong>Methods: </strong>Rapid antigen test evaluations were performed through drive-through testing centres in Durban, South Africa, from July to December 2021. Two evaluation studies were performed: nasal Panbio COVID-19 Ag Rapid Test Device (Abbott) was evaluated in parallel with the nasopharyngeal Espline SARS-CoV-2 Ag test (Fujirebio), followed by the evaluation of nasal RightSign COVID-19 Antigen Rapid test Cassette (Hangzhou Biotest Biotech) in parallel with the nasopharyngeal STANDARD Q COVID-19 Ag test (SD Biosensor). The Abbott RealTime SARS-CoV-2 assay was used as a reference test.</p><p><strong>Results: </strong>Evaluation of Panbio and Espline Ag tests was performed on 494 samples (31% positivity), while the evaluation of Standard Q and RightTest Ag tests was performed on 539 samples (13.17% positivity). The overall sensitivity for all four tests ranged between 60 and 72% with excellent specificity values (> 98%). Sensitivity increased to > 80% in all tests in samples with cycle number value < 20. All four tests performed best in samples from patients presenting within the first week of symptom onset.</p><p><strong>Conclusions: </strong>All four evaluated tests detected a majority of the cases within the first week of symptom onset with high viral load.</p>","PeriodicalId":72800,"journal":{"name":"Diagnostic and prognostic research","volume":"7 1","pages":"14"},"PeriodicalIF":0.0,"publicationDate":"2023-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10369830/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10240470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnostic accuracy of a rapid nucleic acid test for group A streptococcal pharyngitis using saliva samples: protocol for a prospective multicenter study in primary care.","authors":"Robert Touitou, Philippe Bidet, Constance Dubois, Henri Partouche, Stéphane Bonacorsi, Camille Jung, Robert Cohen, Corinne Levy, Jérémie F Cohen","doi":"10.1186/s41512-023-00150-4","DOIUrl":"10.1186/s41512-023-00150-4","url":null,"abstract":"<p><strong>Background: </strong>Group A streptococcus is found in 20-40% of cases of childhood pharyngitis; the remaining cases are viral. Streptococcal pharyngitis (\"strep throat\") is usually treated with antibiotics, while these are not indicated in viral cases. Most guidelines recommend relying on a diagnostic test confirming the presence of group A streptococcus before prescribing antibiotics. Conventional first-line tests are rapid antigen detection tests based on throat swabs. Recently, rapid nucleic acid tests were developed; they allow the detection of elements of the genome of group A streptococcus. We hypothesize that these rapid nucleic acid tests are sensitive enough to be performed on saliva samples instead of throat swabs, which could be more convenient in practice.</p><p><strong>Methods: </strong>This is a multicenter, prospective diagnostic accuracy study evaluating the performance of a rapid nucleic acid test for group A streptococcus (Abbott ID NOW STREP A2) in saliva, compared with a conventional pharyngeal rapid antigen detection test (EXACTO PRO STREPTATEST, lateral flow assay, comparator test), with a composite reference standard of throat culture and group A streptococcus PCR in children with pharyngitis in primary care (i.e., 27 primary care pediatricians or general practitioners). To ensure group A streptococcus is not missed, the salivary rapid nucleic acid test requires a minimally acceptable value of sensitivity (primary outcome) set at 80%. Assuming 35% of participants will have group A streptococcus, we will recruit 800 consecutive children with pharyngitis. Secondary outcomes will include difference in sensitivity between the pharyngeal rapid antigen detection test and the salivary rapid nucleic acid test; variability in sensitivity and specificity of the salivary rapid nucleic acid test with the level of McIsaac score; time to obtain the result of the salivary rapid nucleic acid test; patient, physician, and parents satisfaction; and barriers and facilitators to using rapid tests for group A streptococcus in primary care.</p><p><strong>Ethics and dissemination: </strong>Approved by the Institutional Review Board \"Comité de protection des personnes Ile de France I\" (no. 2022-A00085-38). Results will be presented at international meetings and disseminated in peer-reviewed journals.</p><p><strong>Trial registration number: </strong>ClinicalTrials.gov: NCT05521568.</p>","PeriodicalId":72800,"journal":{"name":"Diagnostic and prognostic research","volume":"7 1","pages":"13"},"PeriodicalIF":0.0,"publicationDate":"2023-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10347703/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10193771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}