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Factors influencing the diagnostic accuracy of the rapid influenza antigen detection test (RIADT): a cross-sectional study.

ABSTRACT: To evaluate the diagnostic accuracy of the rapid influenza antigen detection test (RIADT) and determine which symptoms are relevant to results.Single-centre, cross-sectional study.Primary care centre, Tokyo, Japan.82 consecutive outpatients presenting with upper respiratory symptoms and fever ?37°C at any time from symptom onset, between December 2010 and April 2011.Results of history and physical examination including age, sex, temperature, time of test from symptom onset, vaccination record and current symptoms (sore throat, arthralgia and/or myalgia, headache, chills, cough and/or throat phlegm, nasal discharge) were recorded. The RIADT and a fully automated respiratory virus nucleic acid test (Verigene Respiratory Virus Plus; VRV), the latter being the gold standard, were performed. Patients were divided into four groups: false negative (FN), RIADT- and VRV+; true positive (TP), RIADT+ and VRV+; true negative (TN), RIADT- and VRV-; and false positive, RIADT+ and VRV-. Groups were compared regarding age, sex, temperature, time of test from symptom onset, vaccination record and symptoms.RIADT sensitivity, specificity, positive predictive value and negative predictive value were 72.9% (95% CI 61.5% to 84.2%), 91.3% (79.7% to 102.8%), 95.6% (89.5% to 101.6%) and 56.8% (40.8% to 72.7%), respectively. Time from symptom onset to test was shorter for the FN group than the TP group (p=0.009). No significant differences were detected for the other factors assessed. Results revealed higher temperatures for FN than TN patients (p=0.043), and more FN than TN patients had chills (p=0.058).The RIADT sensitivity was low, due to early administration of the test. In the epidemic season, the RIADT should not be used for suspected influenza until 12 h after symptom onset. A positive RIADT firmly supports the influenza diagnosis; a negative result does not confirm its absence. High fever and chills might indicate influenza, but additional tests are sometimes necessary.

SUBMITTER: Tanei M

PROVIDER: S-EPMC3902527 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Factors influencing the diagnostic accuracy of the rapid influenza antigen detection test (RIADT): a cross-sectional study.

Tanei Mika M Yokokawa Hirohide H Murai Kenji K Sakamoto Rino R Amari Yu Y Boku Soushin S Inui Akihiro A Fujibayashi Kazutoshi K Uehara Yuki Y Isonuma Hiroshi H Kikuchi Ken K Naito Toshio T

BMJ open 20140102 1

<h4>Objective</h4>To evaluate the diagnostic accuracy of the rapid influenza antigen detection test (RIADT) and determine which symptoms are relevant to results.<h4>Design</h4>Single-centre, cross-sectional study.<h4>Setting</h4>Primary care centre, Tokyo, Japan.<h4>Participants</h4>82 consecutive outpatients presenting with upper respiratory symptoms and fever ≥37°C at any time from symptom onset, between December 2010 and April 2011.<h4>Main outcome measures</h4>Results of history and physical ...[more]

PMID: 24384898

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Project description:BackgroundRapid antigen diagnostic tests (Ag-RDTs) are the most widely used point-of-care tests for detecting SARS-CoV-2 infection. Since the accuracy may have altered by changes in SARS-CoV-2 epidemiology, indications for testing, sampling and testing procedures, and roll-out of COVID-19 vaccination, we evaluated the performance of three prevailing SARS-CoV-2 Ag-RDTs.MethodsIn this cross-sectional study, we consecutively enrolled individuals aged >16 years presenting for SARS-CoV-2 testing at three Dutch public health service COVID-19 test sites. In the first phase, participants underwent either BD-Veritor System (Becton Dickinson), PanBio (Abbott), or SD-Biosensor (Roche Diagnostics) testing with routine sampling procedures. In a subsequent phase, participants underwent SD-Biosensor testing with a less invasive sampling method (combined oropharyngeal-nasal [OP-N] swab). Diagnostic accuracies were assessed against molecular testing.ResultsSix thousand nine hundred fifty-five of 7005 participants (99%) with results from both an Ag-RDT and a molecular reference test were analysed. SARS-CoV-2 prevalence and overall sensitivities were 13% (188/1441) and 69% (129/188, 95% CI 62-75) for BD-Veritor, 8% (173/2056) and 69% (119/173, 61-76) for PanBio, and 12% (215/1769) and 74% (160/215, 68-80) for SD-Biosensor with routine sampling and 10% (164/1689) and 75% (123/164, 68-81) for SD-Biosensor with OP-N sampling. In those symptomatic or asymptomatic at sampling, sensitivities were 72-83% and 54-56%, respectively. Above a viral load cut-off (≥5.2 log10 SARS-CoV-2 E-gene copies/mL), sensitivities were 86% (125/146, 79-91) for BD-Veritor, 89% (108/121, 82-94) for PanBio, and 88% (160/182, 82-92) for SD-Biosensor with routine sampling and 84% (118/141, 77-89) with OP-N sampling. Specificities were >99% for all tests in most analyses. Sixty-one per cent of false-negative Ag-RDT participants returned for testing within 14 days (median: 3 days, interquartile range 3) of whom 90% tested positive.ConclusionsOverall sensitivities of three SARS-CoV-2 Ag-RDTs were 69-75%, increasing to ≥86% above a viral load cut-off. The decreased sensitivity among asymptomatic participants and high positivity rate during follow-up in false-negative Ag-RDT participants emphasise the need for education of the public about the importance of re-testing after an initial negative Ag-RDT should symptoms develop. For SD-Biosensor, the diagnostic accuracy with OP-N and deep nasopharyngeal sampling was similar; adopting the more convenient sampling method might reduce the threshold for professional testing.

Project description:BackgroundScreening for opisthorchiasis, a parasitic worm infection affecting many millions of people in Southeast Asia, has traditionally relied on faecal egg examination such as the formalin-ethyl acetate concentration technique (FECT) and Kato-Katz method. Although the urinary enzyme-linked immunosorbent assay (ELISA) has been used more recently, we developed a urinary antigen-based rapid diagnostic test (RDT) to simplify diagnosis and as a point-of-care testing (POCT) and field applications for surveillance and control of opisthorchiasis.MethodsA urinary Opisthorchis viverrini (OV)-RDT was developed using immunochromatographic methodology with a specific monoclonal antibody against OV. The diagnostic performance of the urinary OV-RDT was compared to that of quantitative faecal FECT and urinary antigen ELISA (n = 493). Cross-reactivities of urinary OV-RDT with other helminthiases coexisted with O. viverrini were determined (n = 96). A field trial in the application of urinary OV-RDT was compared with urinary antigen ELISA at baseline screening and assessment of drug treatment outcomes in opisthorchiasis (n = 1629). The McNemar chi-square, Kruskal-Wallis and Cohen's kappa coefficient (κ-value) tests were used for statistical analyses.ResultsUrinary OV-RDT had sensitivity of 94.2% and specificity of 93.2%, compared to faecal FECT. Urinary OV-RDT had high diagnostic agreement (Kappa = 0.842-0.874, P < 0.001) and quantitative correlation with urinary antigen ELISA (Kruskal-Wallis tests = 316.2, P < 0.0001) and faecal FECT (Kruskal-Wallis tests = 362.3, P < 0.0001). The positive rates by OV-RDT, ELISA and FECT were 48.9%, 52.5% and 49.3%, respectively. Cross-reactions of urinary OV-RDT with other helminthiases were few (2%). Field trials of urinary OV-RDT yielded comparable prevalence of O. viverrini between urinary OV-RDT (53.2%) and urinary antigen ELISA (54.0%). OV screening showed high diagnostic agreement (kappa > 0.8, P < 0.0001) between urinary OV-RDT and urinary antigen ELISA. The cure rates of opisthorchiasis at 1 month post-praziquantel treatment determined by urinary OV-RDT (86.6%) and urinary antigen ELISA (80.5%) were similar (P > 0.05).ConclusionsThe urinary OV-RDT test has high potential as a new tool for screening and evaluating treatment outcomes in opisthorchiasis. The ease of sample collection and simplicity of urinary OV-RDT may facilitate mass screening, control and elimination of opisthorchiasis, thereby contributing to a reduction in the disease burden in Southeast Asia.

Project description:Background Accurate and timely diagnosis is essential in limiting the spread of SARS-CoV-2 infection. The reference standard, rRT-PCR, requires specialized laboratories, costly reagents, and a long turnaround time. Antigen RDTs provide a feasible alternative to rRT-PCR since they are quick, relatively inexpensive, and do not require a laboratory. The WHO requires that Ag RDTs have a sensitivity ≥80% and specificity ≥97%. Methods This evaluation was conducted at 11 health facilities in Kenya between March and July 2021. We enrolled persons of any age with respiratory symptoms and asymptomatic contacts of confirmed COVID-19 cases. We collected demographic and clinical information and two nasopharyngeal specimens from each participant for Ag RDT testing and rRT-PCR. We calculated the diagnostic performance of the Panbio™ Ag RDT against the US Centers for Disease Control and Prevention’s (CDC) rRT-PCR test. Results We evaluated the Ag RDT in 2,245 individuals where 551 (24.5%, 95% CI: 22.8–26.3%) tested positive by rRT-PCR. Overall sensitivity of the Ag RDT was 46.6% (95% CI: 42.4–50.9%), specificity 98.5% (95% CI: 97.8–99.0%), PPV 90.8% (95% CI: 86.8–93.9%) and NPV 85.0% (95% CI: 83.4–86.6%). Among symptomatic individuals, sensitivity was 60.6% (95% CI: 54.3–66.7%) and specificity was 98.1% (95% CI: 96.7–99.0%). Among asymptomatic individuals, sensitivity was 34.7% (95% CI 29.3–40.4%) and specificity was 98.7% (95% CI: 97.8–99.3%). In persons with onset of symptoms <5 days (594/876, 67.8%), sensitivity was 67.1% (95% CI: 59.2–74.3%), and 53.3% (95% CI: 40.0–66.3%) among those with onset of symptoms >7 days (157/876, 17.9%). The highest sensitivity was 87.0% (95% CI: 80.9–91.8%) in symptomatic individuals with cycle threshold (Ct) values ≤30. Conclusion The overall sensitivity and NPV of the Panbio™ Ag RDT were much lower than expected. The specificity of the Ag RDT was high and satisfactory; therefore, a positive result may not require confirmation by rRT-PCR. The kit may be useful as a rapid screening tool only for symptomatic patients in high-risk settings with limited access to rRT-PCR. A negative result should be interpreted based on clinical and epidemiological information and may require retesting by rRT-PCR.

Project description:BackgroundIn low resource settings, Salmonella serovars frequently cause bloodstream infections. This study investigated the diagnostic performance of immunochromatographic rapid diagnostic tests (RDTs), which detect Salmonella antigens, when applied to stored grown blood culture broth.Material/methodsThe SD Bioline One Step Salmonella Typhi Ag Rapid Detection Kit (Standard Diagnostics, Republic of Korea), marketed for the detection of Salmonella enterica serovar Typhi (Salmonella Typhi) in stool and the Salmonella Ag Rapid Test (Creative Diagnostics, USA), marketed for the detection of all Salmonella serotypes in stool, were selected for evaluation based on a pre-test evaluation of six RDT products. The limits of detection (LOD) for culture suspensions were established and the selected RDT products were assessed on 19 freshly grown spiked blood culture broth samples and 413 stored clinical blood culture broth samples, collected in Cambodia and the Democratic Republic of the Congo.ResultsThe LOD of both products was established as 107-108 CFU/ml. When applied to clinical blood culture broth samples, the diagnostic sensitivity and specificity of the SD Bioline RDT were respectively 100% and 79.7% for the detection of Salmonella Typhi; 94.4% (65/69) of false-positive results were caused by Salmonella Enteritidis. When considering the combined detection of Salmonella Typhi and Enteritidis (both group D Salmonella), sensitivity and specificity were 97.9% and 98.5% respectively. For Creative Diagnostics, diagnostic sensitivity was 78.3% and specificity 91.0% for all Salmonella serotypes combined; 88.3% (53/60) of false negative results were caused by Salmonella Paratyphi A.ConclusionsWhen applied to grown blood culture broths, the SD Bioline RDT had a good sensitivity and specificity for the detection of Salmonella Typhi and Salmonella Enteritidis. The Creative Diagnostics product had a moderate sensitivity and acceptable specificity for the detection of all Salmonella serovars combined and needs further optimization. A RDT that reliably detects Salmonella Paratyphi A is needed.

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Factors influencing the diagnostic accuracy of the rapid influenza antigen detection test (RIADT): a cross-sectional study.

Publications

Factors influencing the diagnostic accuracy of the rapid influenza antigen detection test (RIADT): a cross-sectional study.

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