Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: A systematic review and meta-analysis

Objective: To systematically assess the diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children under real-life conditions. Study design: Multiple bibliographic databases including MEDLINE and Embase, clinical trial registries and further information sources were systematically searched for literature (last bibliographic search: May 7, 2021). Diagnostic cross-sectional or cohort studies that included paediatric study participants and evaluated rapid point-of care tests for diagnosing current SARS-CoV-2 infections against RT-PCR as the reference standard were eligible for inclusion. QUADAS-2 was used to assess the risk of bias and the applicability of the included studies. Bivariate meta-analyses with random effects were performed. Variability was assessed by subgroup analyses. Results: We included 17 studies with a total of 6355 paediatric study participants. All included studies compared antigen tests against RT-PCR. Only one study was at low risk of bias. The pooled overall diagnostic sensitivity and specificity in paediatric populations was 64.2% (95% CI: 57.4%-70.5%) and 99.1% (95% CI: 98.2%-99.5%), respectively. In symptomatic children, the pooled diagnostic sensitivity was 71.8% (95% CI: 63.6%-78.8%) and the pooled diagnostic specificity was 98.7% (95% CI: 96.6%-99.5%). The pooled diagnostic sensitivity in asymptomatic children was 56.2% (95% CI: 47.6%-64.4%) and the pooled diagnostic specificity was 98.6% (95% CI: 97.3%-99.3%). Conclusions: Performance of current antigen tests under real-life conditions varies broadly. Policymakers should especially be aware of the low diagnostic sensitivity of current antigen tests. Results should be interpreted with caution since risk of bias was predominantly judged as unclear due to poor reporting. Study Registration: CRD42021236313 (PROSPERO).

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Nasopharyngeal Panbio COVID-19 antigen performed at point-of-care has a high sensitivity in symptomatic and asymptomatic patients with higher risk for transmission and older age

10.1101/2020.11.16.20230003 ◽

2020 ◽

Author(s):

Mar Masiá ◽

Marta Fernández-González ◽

Manuel Sánchez ◽

Mar Carvajal ◽

José Alberto García ◽

...

Keyword(s):

Point Of Care ◽

Real Life ◽

Older Age ◽

Antigen Test ◽

Rt Pcr ◽

Life Conditions ◽

Asymptomatic Patients ◽

Clinical Scenarios ◽

Highly Sensitive ◽

Nasal Swabs

ABSTRACTBackgroundPerformance of point-of-care tests in clinical practice remains undetermined. We aimed to evaluate the performance of the nasopharyngeal Panbio COVID-19 antigen Rapid Test Device in real-life conditions in different clinical scenarios.MethodProspective study conducted in three primary care centers (PCC) and an emergency department. The antigen test was performed at point-of-care in nasopharyngeal and nasal swabs, and in saliva. Positive and negative percent agreement (PPA, NPA) were calculated with the RT-PCR assay as reference standard.ResultsOf 913 patients included, 296 (32.3%) were asymptomatic and 690 (75.6%) came from the PCC. Nasopharyngeal swabs were collected from 913, nasal swabs from 659, and saliva from 611 patients. RT-PCR was positive in 196 (21.5%) nasopharyngeal samples (NPS). Overall PPA (95% CI) in NPS was 60.5% (53.3-67.4), and it was lower in nasal swabs (44.7%) and saliva (23.1%). Test performance in NPS was largely dependent on the cycle threshold (Ct) in RT-PCR, with PPA>90% for Ct≤25 and ≥80% for Ct<30. In symptomatic patients, the PPA was 95% for Ct≤25; ≥85% for Ct<30, and 89% for the symptom triad of fever, cough and malaise. Performance was also dependent on age, with PPA of 100% in symptomatic patients >50 years with Ct<25. In asymptomatic patients, the PPA was 86% for Ct<25. In all cases, NPA was 100%.ConclusionThe nasopharyngeal Panbio COVID-19 antigen test performed at point-of-care is highly sensitive in symptomatic patients, particularly with Ct<30 and older age. The test was useful to identify asymptomatic patients with lower Ct values and therefore with contagious risk.Key pointsThe nasopharyngeal Panbio-COVID-19 antigen test performed in real-life conditions at point-of-care is highly sensitive in symptomatic patients, particularly with Ct<30 and older age. The test is useful to identify asymptomatic patients with lower Ct values and therefore with contagious risk.

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Risk of bias and limits of reporting in diagnostic accuracy studies for commercial point-of-care tests for respiratory pathogens

Epidemiology and Infection ◽

10.1017/s0950268818000596 ◽

2018 ◽

Vol 146 (6) ◽

pp. 747-756

Author(s):

J.M. Hughes ◽

C. Penney ◽

S. Boyd ◽

P. Daley

Keyword(s):

Diagnostic Accuracy ◽

Test Performance ◽

Point Of Care ◽

Risk Of Bias ◽

Financial Impact ◽

Test Accuracy ◽

Respiratory Pathogens ◽

Study Results ◽

Group A ◽

Point Of Care Tests

AbstractCommercial point-of-care (POC) diagnostic tests for Group A Streptococcus, Streptococcus pneumoniae, and influenza virus have large potential diagnostic and financial impact. Many published reports on test performance, often funded by diagnostics companies, are prone to bias. The Standards for Reporting of Diagnostic Accuracy (STARD 2015) are a protocol to encourage accurate, transparent reporting. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool evaluates risk of bias and transportability of results. We used these tools to evaluate diagnostic test accuracy studies of POC studies for three respiratory pathogens. For the 96 studies analysed, compliance was <25% for 14/34 STARD 2015 standards, and 3/7 QUADAS-2 domains showed a high risk of bias. All reports lacked reporting of at least one criterion. These biases should be considered in the interpretation of study results.

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Decreased Sensitivity of the Serological Detection of Feline Immunodeficiency Virus Infection Potentially Due to Imported Genetic Variants

Viruses ◽

10.3390/v11080697 ◽

2019 ◽

Vol 11 (8) ◽

pp. 697 ◽

Cited By ~ 3

Author(s):

Julia Frankenfeld ◽

Theres Meili ◽

Marina Meli ◽

Barbara Riond ◽

A. Helfer-Hungerbuehler ◽

...

Keyword(s):

Feline Immunodeficiency Virus ◽

Point Of Care ◽

Diagnostic Efficiency ◽

Rt Pcr ◽

Viral Loads ◽

Feline Immunodeficiency Virus Infection ◽

Immunodeficiency Virus ◽

Screening Assays ◽

Diagnostic Sensitivity And Specificity ◽

Point Of Care Tests

Feline immunodeficiency virus (FIV) is a lentivirus of domestic cats worldwide. Diagnosis usually relies on antibody screening by point-of-care tests (POCT), e.g., by enzyme-linked immunosorbent assays (ELISA), and confirmation using Western blot (WB). We increasingly observed ELISA-negative, WB-positive samples and aimed to substantiate these observations using 1194 serum/plasma samples collected from 1998 to 2019 primarily from FIV-suspect cats. While 441 samples tested positive and 375 tested negative by ELISA and WB, 81 samples had discordant results: 70 were false ELISA-negative (WB-positive) and 11 were false ELISA-positive (WB-negative); 297 ambiguous results were not analyzed further. The diagnostic sensitivity and specificity of the ELISA (82% and 91%, respectively) were lower than those reported in 1995 (98% and 97%, respectively). The diagnostic efficiency was reduced from 97% to 86%. False ELISA-negative samples originated mainly (54%) from Switzerland (1995: 0%). Sixty-four false ELISA-negative samples were available for POCT (SNAPTM/WITNESSR): five were POCT-positive. FIV RT-PCR was positive for two of these samples and was weakly positive for two ELISA- and POCT-negative samples. Low viral loads prohibited sequencing. Our results suggest that FIV diagnosis has become more challenging, probably due to increasing travel by cats and the introduction of new FIV isolates not recognized by screening assays.

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Field evaluation of specificity and sensitivity of a standard SARS-CoV-2 antigen rapid diagnostic test: A prospective study at a teaching hospital in Northern Ghana

PLOS Global Public Health ◽

10.1371/journal.pgph.0000040 ◽

2021 ◽

Vol 1 (12) ◽

pp. e0000040

Author(s):

Alhassan Abdul-Mumin ◽

Abdulai Abubakari ◽

Faith Agbozo ◽

Abass Abdul-Karim ◽

Benjamin Demah Nuertey ◽

...

Keyword(s):

Teaching Hospital ◽

Real Life ◽

Field Evaluation ◽

Northern Ghana ◽

Rt Pcr ◽

Cross Sectional ◽

Life Conditions ◽

Specificity And Sensitivity ◽

Low Sensitivity ◽

A Prospective Study

The testing capacity for SARS-CoV-2 in Africa is rather limited. Antigen detection rapid diagnostic tests (Ag-RDTs) are a cheap and rapid alternative to reverse transcriptase-polymerase chain reaction (RT-PCR) tests, but there is little data about their performance under real life conditions in tropical countries. The objective of this study is to evaluate the performance of a standard Ag-RDT in a population of a major hospital in northern Ghana. Prospective, cross-sectional, blinded verification of the performance of the SD Biosensor Standard Q SARS-CoV-2 Ag-RDT under real life conditions in 135 symptomatic patients and 58 contacts of RT-PCR positives at Tamale Teaching Hospital in February 2021. Nasopharyngeal samples were taken under standard conditions and tested against RT-PCR in the hospital laboratory. 193 participants (median age 35 years, 109 male) were included into the study for which both RT-PCR test and Ag-RDT results were available. A total of 42 (22%) were RT-PCR positive. Of the 42 RT-PCR positives, 27 were Ag-RDT positive, resulting in a sensitivity of 64% (95% CI 49–79). Sensitivity among symptomatic patients was 58% (95% CI 38–78). 123 were identified Ag-RDT negatives of the 151 RT-PCR negatives, resulting in a specificity of 81% (95% CI 75–87). SARS-CoV-2 Ag-RDTs appear to have a rather low sensitivity and particularly a low specificity under real life conditions in Africa. The role of existing Ag-RDTs in countries with high-temperature climates and limited resources still needs more data and discussion.

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Real-life evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for SARS-CoV-2 detection in asymptomatic close contacts of COVID-19 patients

10.1101/2020.12.01.20241562 ◽

2020 ◽

Cited By ~ 1

Author(s):

Ignacio Torres ◽

Sandrine Poujois ◽

Eliseo Albert ◽

Javier Colomina ◽

David Navarro

Keyword(s):

Point Of Care ◽

Real Life ◽

Rapid Test ◽

Optimal Timing ◽

Upper Respiratory Tract ◽

Limited Information ◽

Rt Pcr ◽

Test Device ◽

Household Contacts ◽

Close Contacts

ABSTRACTObjectivesThere is limited information on the performance of rapid antigen detection (RAD) tests to identify SARS-CoV-2-infected asymptomatic individuals. In this field study, we evaluated the Panbio™ COVID-19 Ag Rapid Test Device (Abbott Diagnostics, Jena, Germany) for the purpose.MethodsA total of 634 individuals (355 female; median age, 37 years; range, 9-87) were enrolled. Household (n=338) contacts were tested at a median of 2 days (range, 1-7) after diagnosis of the index case and non-household contacts (n=296) at a median of 6 days (range, 1-7) after exposure. RAD testing was carried out at the point of care. The RT-PCR test used was the TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Massachusetts, USA).ResultsIn total, 79 individuals (12.4%) tested positive by RT-PCR, of whom 38 (48.1%) yielded positive RAD results. The overall sensitivity and specificity of the RAD test was 48.1% (95% CI: 37.4-58.9) and 100% (95% CI: 99.3-100), respectively. Sensitivity was higher in household (50.8%; 95% CI: 38.9-62.5) than in non-household (35.7%; 95% CI:16.3-61.2%) contacts. Individuals testing positive by RAD test were more likely (P<0.001) to become symptomatic than their negative counterparts.ConclusionThe Panbio test displays low sensitivity in asymptomatic close contacts of COVID-19 patients, particularly in non-household contacts. Nonetheless, establishing the optimal timing for upper respiratory tract collection in this group seems imperative to pinpoint test sensitivity.

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Field evaluation of specificity and sensitivity of a standard SARS-CoV-2 antigen rapid diagnostic test: A prospective study at a teaching hospital in Northern Ghana

10.1101/2021.06.03.21258300 ◽

2021 ◽

Author(s):

Alhassan Abdul-Mumin ◽

Abdulai Abubakari ◽

Faith Agbozo ◽

Abass Abdul-Karim ◽

Benjamin Demah Nuertey ◽

...

Keyword(s):

Teaching Hospital ◽

Real Life ◽

Field Evaluation ◽

Northern Ghana ◽

Rt Pcr ◽

Cross Sectional ◽

Life Conditions ◽

Specificity And Sensitivity ◽

Low Sensitivity ◽

A Prospective Study

Background: The testing capacity for SARS-CoV-2 in Africa is rather limited. Antigen-detection rapid diagnostic tests (Ag-RDTs) are a cheap and rapid alternative to reverse transcriptase-polymerase chain reaction (RT-PCR) tests, but there is little data about their performance under real life conditions in tropical countries. Objective: To evaluate the performance of a standard Ag-RDT in a population of a major hospital in northern Ghana. Methods: Prospective, cross-sectional, blinded verification of the performance of the SD Biosensor Standard Q SARS-CoV-2 Ag-RDT under real life conditions in 135 symptomatic patients and 58 contacts of RT-PCR positives at Tamale Teaching Hospital in February 2021. Nasopharyngeal samples were taken under standard conditions and tested against RT-PCR in the hospital laboratory. Results: 193 participants (median age 35 years, 109 male) were included into the study for which both RT-PCR test and Ag-RDT results were available. A total of 42 (22%) were RT-PCR-positive. Of the 42 RT-PCR-positives, 27 were Ag-RDT positive, resulting in a sensitivity of 64% (95% CI 49-79). Sensitivity among symptomatic patients was 58% (95% CI 38-78). 123 were identified Ag-RDT negatives of the 151 RT-PCR negatives, resulting in a specificity of 81% (95% CI 75-87). Conclusions: SARS-CoV-2 Ag-RDTs appear to have a rather low sensitivity and particularly a low specificity under real life conditions in Africa. The role of existing Ag-RDTs in countries with high-temperature climates and limited resources still needs more data and discussion.

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RECENT DEVELOPMENTS IN LABORATORY DIAGNOSIS OF COVID-19 INFECTION- AN UPDATE

10.36106/gjra/8509621 ◽

2021 ◽

pp. 58-60

Author(s):

Ivneet Kour ◽

Lipika Singhal ◽

Varsha Gupta

Keyword(s):

Point Of Care ◽

Laboratory Diagnosis ◽

Public Health Emergency ◽

World Health ◽

Global Public Health ◽

Rt Pcr ◽

Testing Strategies ◽

Recent Developments ◽

Health Organization ◽

Point Of Care Tests

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This new virus and disease were unknown before the outbreak began in Wuhan, Hubei Province of China, in December 2019. The World Health Organization (WHO) initially declared COVID19 as the global public health emergency on 30th January 2020 and subsequently a pandemic on March 11, 2020. Besides availability of RT-PCR there is need for development of rapid point of care tests with better sensitivity and specicity which helps in early and accurate diagnosis and also aids in containing the spread . This review summarizes various molecular diagnostics methods, technical guidelines, and advanced testing strategies adopted in India for laboratory diagnosis of COVID-19.

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The Performance of Two Rapid Antigen Tests During Population-Level Screening for SARS-CoV-2 Infection

Frontiers in Medicine ◽

10.3389/fmed.2021.797109 ◽

2021 ◽

Vol 8 ◽

Author(s):

Mohammad Alghounaim ◽

Hamad Bastaki ◽

Farah Bin Essa ◽

Hoda Motlagh ◽

Salman Al-Sabah

Keyword(s):

Positive Predictive Value ◽

Prospective Study ◽

Predictive Value ◽

Point Of Care ◽

Population Level ◽

Lower Sensitivity ◽

Rt Pcr ◽

Antigen Tests ◽

A Prospective Study ◽

Antigen Testing

Background: SARS-CoV-2 antigen assays offer a rapid mean to diagnose and isolate infected individuals. However, their utility in population-level screening is unknown.Objectives: The performance of two antigen tests in detecting SARS-CoV-2 was assessed among individuals randomly selected in the community.Study Design: A prospective study that performed head-to-head comparison of two SARS-CoV-2 antigen assays. Individuals were recruited during community SARS-CoV-2 screening over 10 working days. Demographic and clinical data were collected. Standard Q COVID-19 Ag test, a point-of-care chromatographic assay, was conducted immediately, and then the sample was transported to the virology laboratory to perform PCR and the LIAISON SARS-CoV-2 Ag chemiluminesence immunoassay.Results: respiratory samples from 991 individuals were collected, and 62 were positive by PCR. Inconclusive PCR results were observed in 19 samples and were excluded. The median age of participants was 40.2 years (IQR 32.3–47.8), and 932 (94%) were males. Most (77.4%) of infections were asymptomatic. The sensitivity and the specificity of the LIAISON assay were 43.3% (95%CI 30.6–56.8) and 99.9% (95%CI 99.3–100). The Standard Q assay had lower sensitivity (30.6%, 95%CI 19.6–43.7) but similar specificity (98.8%, 95%CI, 97.8–99.4). Similarly, the LIAISON assay had higher positive predictive value (96.3%, 95%CI 81–99.9% vs. 63.3%, 95%CI, 43.9–80.1%). Both assays performed better in symptomatic patients and among samples with a low-cycle threshold (Ct < 25).Conclusion: In our setting of random community surveillance, rapid antigen testing of nasopharyngeal swabs by either LIAISON SARS-CoV-2 Ag (DiaSorin) or Standard Q COVID-19 Ag (SD Biosensor) was less sensitive to detecting SARS-CoV-2 than the TaqPath COVID-19 RT-PCR.

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Real-World Clinical Performance of the Abbott Panbio with Nasopharyngeal, Throat and Saliva Swabs Among Symptomatic Individuals with COVID-19

10.1101/2021.01.02.21249138 ◽

2021 ◽

Author(s):

William Stokes ◽

Byron Berenger ◽

Danielle Portnoy ◽

Brittney Scott ◽

Jonas Szelewicki ◽

...

Keyword(s):

Symptom Onset ◽

Clinical Performance ◽

Point Of Care ◽

Community Setting ◽

Poor Performance ◽

Community Assessment ◽

Rt Pcr ◽

United States Food ◽

States Food ◽

Antigen Tests

BACKGROUND Point of Care Testing (POCT) SARS-CoV-2 antigen tests, such as the Abbott Panbio, have great potential to help combat the COVID-19 pandemic. The Panbio is United States Food and Drug Administration (FDA) approved for the detection of SARS-CoV-2 in symptomatic individuals within the first 7 days of COVID-19 symptom onset(s). METHODS Symptomatic adults recently diagnosed with COVID-19 in the community were recruited into the study. Paired nasopharyngeal (NP), throat, and saliva swabs were collected, with one paired swab tested immediately with the Panbio, and the other transported in universal transport media and tested using reverse-transcriptase polymerase chain reaction (RT-PCR). Positive percent agreement (PPA) was calculated. Subsequently, individuals within 7 days of symptom onset who presented to community assessment centres for SARS-CoV-2 testing had Panbio testing completed and paired with RT-PCR results from parallel NP or throat swabs. RESULTS 145 individuals were included in the study. Collection of throat and saliva was stopped early due to poor performance (throat PPA 57.7%, n=61, and saliva PPA 2.6%, n=41). NP swab PPA was 87.7% [n=145, 95% confidence interval 81.0% - 92.7%]. There were 1,641 symptomatic individuals tested by Panbio in community assessment centres, with 268/1641 (16.3%) positive for SARS-CoV-2. There were 37 false negatives, corresponding to a PPA of 86.2% [81.5% - 90.1%]. CONCLUSIONS The Panbio test reliably detects most cases of SARS-CoV-2 from adults in the POCT community setting presenting within 7 days of symptom onset using nasopharyngeal swabs. Throat and saliva swabs are not reliable specimens for the Panbio.

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Characteristics of children and antigen test performance at a SARS-CoV-2 community testing site

10.1101/2021.07.06.21259792 ◽

2021 ◽

Author(s):

Laura Ford ◽

Melissa J. Whaley ◽

Melisa M. Shah ◽

Phillip P. Salvatore ◽

Hannah E. Segaloff ◽

...

Keyword(s):

Test Performance ◽

Point Of Care ◽

Lower Sensitivity ◽

Antigen Test ◽

Rt Pcr ◽

Culture Methods ◽

Viral Culture ◽

Asymptomatic Children ◽

Testing Site ◽

Antigen Tests

Background: Performance characteristics of SARS-CoV-2 antigen tests among children are limited despite the need for point-of-care testing in school and childcare settings. We describe children seeking SARS-CoV-2 testing at a community site and compare antigen test performance to real-time reverse transcription-polymerase chain reaction (RT-PCR) and viral culture. Methods: Two anterior nasal specimens were self-collected for BinaxNOW antigen and RT-PCR testing, along with demographics, symptoms, and exposure information from individuals ≥5 years at a community testing site. Viral culture was attempted on residual antigen or RT-PCR positive specimens. Demographic and clinical characteristics, and the performance of SARS-CoV-2 antigen tests, were compared among children (<18 years) and adults. Results: About one in ten included specimens were from children (225/2110); 16.4% (37/225) were RT-PCR positive. Cycle threshold values were similar among RT-PCR positive specimens from children and adults (22.5 vs 21.3, p=0.46) and among specimens from symptomatic and asymptomatic children (22.5 vs 23.2, p=0.39). Sensitivity of antigen test compared to RT-PCR was 73.0% (27/37) among specimens from children and 80.8% (240/297) among specimens from adults; among specimens from children, specificity was 100% (188/188), positive and negative predictive value were 100% (27/27) and 94.9% (188/198) respectively. Virus was isolated from 51.4% (19/37) of RT-PCR positive pediatric specimens; all 19 had positive antigen test results. Conclusions : With lower sensitivity relative to RT-PCR, antigen tests may not diagnose all positive COVID-19 cases; however, antigen testing identified children with live SARS-CoV-2 virus.

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