The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2—Evaluation of the accuracy and ease-of-use

Objectives Diagnostics are essential for controlling the pandemic. Identifying a reliable and fast diagnostic device is needed for effective testing. We assessed performance and ease-of-use of the Abbott PanBio antigen-detecting rapid diagnostic test (Ag-RDT). Methods This prospective, multi-centre diagnostic accuracy study enrolled at two sites in Germany. Following routine testing with reverse-transcriptase polymerase chain reaction (RT-PCR), a second study-exclusive swab was performed for Ag-RDT testing. Routine swabs were nasopharyngeal (NP) or combined NP/oropharyngeal (OP) whereas the study-exclusive swabs were NP. To evaluate performance, sensitivity and specificity were assessed overall and in predefined sub-analyses accordingly to cycle-threshold values, days after symptom onset, disease severity and study site. Additionally, an ease-of-use assessment (EoU) and System Usability Scale (SUS) were performed. Results 1108 participants were enrolled between Sept 28 and Oct 30, 2020. Of these, 106 (9.6%) were PCR-positive. The Abbott PanBio detected 92/106 PCR-positive participants with a sensitivity of 86.8% (95% CI: 79.0% - 92.0%) and a specificity of 99.9% (95% CI: 99.4%-100%). The sub-analyses indicated that sensitivity was 95.8% in Ct-values <25 and within the first seven days from symptom onset. The test was characterized as easy to use (SUS: 86/100) and considered suitable for point-of-care settings. Conclusion The Abbott PanBio Ag-RDT performs well for SARS-CoV-2 testing in this large manufacturer independent study, confirming its WHO recommendation for Emergency Use in settings with limited resources.

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Evaluation of the accuracy and ease-of-use of Abbott PanBio - A WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2

10.1101/2020.11.27.20239699 ◽

2020 ◽

Cited By ~ 1

Author(s):

L.J. Krüger ◽

M. Gaeddert ◽

F. Tobian ◽

F. Lainati ◽

C. Gottschalk ◽

...

Keyword(s):

Diagnostic Test ◽

Point Of Care ◽

Independent Study ◽

Ease Of Use ◽

Routine Testing ◽

System Usability Scale ◽

Accuracy Study ◽

Internal Funds ◽

Charité Berlin ◽

Large Manufacturer

AbstractBackgroundDiagnostics are essential for controlling the pandemic. Identifying a reliable and fast diagnostic is needed to support testing. We assessed performance and ease-of-use of the Abbott PanBio antigen-detecting rapid diagnostic test (Ag-RDT).MethodsThis prospective, multi-centre diagnostic accuracy study enrolled at two sites in Germany. Following routine testing with RT-PCR, a second study-exclusive swab was performed for Ag-RDT testing. Routine swabs were nasopharyngeal (NP) or combined NP/oropharyngeal (OP) whereas the study-exclusive swabs were NP. To evaluate performance, sensitivity and specificity were assessed overall and in predefined sub analyses accordingly to cycle-threshold values, days of symptoms, disease severity and study site. Additionally, an ease-of-use assessment and System Usability Scale (SUS) were performed.Findings1108 participants were enrolled between Sept 28 and Oct 30, 2020. Of these, 106 (9·6%) were PCR-positive. The Abbott PanBio detected 92/106 PCR-positive participants with a sensitivity of 86·8% (95% CI: 79·0% - 92·0%) and a specificity of 99·9% (95% CI: 99·4%-100%). The sub analyses indicated that sensitivity was 95·8% in CT-values <25 and within the first seven days from symptom onset. The test was characterized as easy to use (SUS: 86/100) and considered suitable for point-of- care settings.InterpretationThe Abbott PanBio Ag-RDT performs well for SARS-CoV-2 testing in this large manufacturer independent study, confirming its WHO recommendation for Emergency Use in settings with limited resources.FundingThe Foundation of Innovative New Diagnostics supplied the test kits for the study. The internal funds from the Heidelberg University as well as the Charité Berlin supported this study.

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Evaluation of the accuracy, ease of use and limit of detection of novel, rapid, antigen-detecting point-of-care diagnostics for SARS-CoV-2

10.1101/2020.10.01.20203836 ◽

2020 ◽

Cited By ~ 19

Author(s):

L.J. Krüger ◽

M. Gaeddert ◽

L. Köppel ◽

L. E. Brümmer ◽

C. Gottschalk ◽

...

Keyword(s):

Limit Of Detection ◽

Point Of Care ◽

Ease Of Use ◽

Rt Pcr ◽

Large Variability ◽

Point Of Care Diagnostics ◽

System Usability Scale ◽

Accuracy Study ◽

The Uk ◽

Analytical Limit

AbstractBackgroundReliable point-of-care (POC) diagnostics not requiring laboratory infrastructure could be a game changer in the COVID-19 pandemic, particularly in the Global South. We assessed performance, limit of detection and ease-of-use of three antigen-detecting, rapid POC tests (Ag-RDT) for SARS-CoV-2.MethodsThis prospective, multi-centre diagnostic accuracy study recruited participants suspected to have SARS-CoV-2 in Germany and the UK. Paired nasopharyngeal swabs (NP) or NP and/or oropharyngeal swabs (OP) were collected from participants (one for clinical RT-PCR and one for Ag-RDT). Performance of each of three Ag-RDTs was compared to RT-PCR overall, and according to predefined subcategories e.g. cycle threshold (CT)-value, days from symptoms onset, etc. In addition, limited verification of the analytical limit-of-detection (LOD) was determined. To understand the usability a System Usability Scale (SUS) questionnaire and ease-of-use (EoU) assessment were performed.ResultsBetween April 17th and August 25th, 2020, 2417 participants were enrolled, with 70 (3.0%) testing positive by RT-PCR. The best-performing test (SD Biosensor, Inc. STANDARD Q) was 76×6% (95% Confidence Interval (CI) 62×8-86×4) sensitive and 99×3% (CI 98×6-99×6) specific. A sub-analysis showed all samples with RT-PCR CT-values <25 were detectable by STANDARD Q. The test was considered easy-to-use (SUS 86/100) and suitable for POC. Bioeasy and Coris showed specificity of 93×1% (CI 91×0%-94×8%) and 95×8% (CI 93×4%-97×4%), respectively, not meeting the predefined target of ≥98%.ConclusionThere is large variability in performance of Ag-RDT with SD Biosensor showing promise. Given the usability at POC, this test is likely to have impact despite imperfect sensitivity; however further research and modelling are needed.

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Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with self-collected anterior nasal swab versus professional-collected nasopharyngeal swab

10.1101/2020.10.26.20219600 ◽

2020 ◽

Cited By ~ 11

Author(s):

Andreas K. Lindner ◽

Olga Nikolai ◽

Franka Kausch ◽

Mia Wintel ◽

Franziska Hommes ◽

...

Keyword(s):

Point Of Care ◽

Rapid Test ◽

High Viral Load ◽

Ease Of Use ◽

Healthcare Personnel ◽

Nasopharyngeal Swab ◽

Swab Sample ◽

Rt Pcr ◽

Percent Agreement ◽

Accuracy Study

AbstractBackgroundTwo antigen-detecting rapid diagnostic tests (Ag-RDTs) are now approved through the WHO Emergency Use Listing procedure and can be performed at the point-of-care. However, both tests use nasopharyngeal (NP) swab samples. NP swab samples must be collected by trained healthcare personnel with protective equipment and are frequently perceived as uncomfortable by patients.MethodsThis was a manufacturer-independent, prospective diagnostic accuracy study with comparison of a supervised, self-collected anterior nose (AN) swab sample with a professional-collected NP swab sample, using a WHO-listed SARS-CoV-2 Ag-RDT, STANDARD Q COVID-19 Ag Test (SD Biosensor), which is also being distributed by Roche. The reference standard was RT-PCR from an oro-/nasopharyngeal swab sample. Percent positive and negative agreement as well as sensitivity and specificity were calculated.ResultsAmong the 289 participants, 39 (13.5%) tested positive for SARS-CoV-2 by RT-PCR. The positive percent agreement of the two different sampling techniques for the Ag-RDT was 90.6% (CI 75.8-96.8). The negative percent agreement was 99.2% (CI 97.2-99.8). The Ag-RDT with AN sampling showed a sensitivity of 74.4% (29/39 PCR positives detected; CI 58.9-85.4) and specificity of 99.2% (CI 97.1-99.8) compared to RT-PCR. The sensitivity with NP sampling was 79.5% (31/39 PCR positives detected; CI 64.5-89.2) and specificity was 99.6% (CI 97.8-100). In patients with high viral load (>7.0 log 10 RNA SARS-CoV2/swab), the sensitivity of the Ag-RDT with AN sampling was 96% and 100% with NP sampling.ConclusionSupervised self-sampling from the anterior nose is a reliable alternative to professional nasopharyngeal sampling using a WHO-listed SARS-CoV-2 Ag-RDT. Considering the ease-of-use of Ag-RDTs, self-sampling and potentially patient self-testing at home may be a future use case.

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

10.21203/rs.3.rs-188293/v1 ◽

2021 ◽

Author(s):

William Stokes ◽

Byron M. Berenger ◽

Danielle Portnoy ◽

Brittney Scott ◽

Jonas Szelewicki ◽

...

Keyword(s):

Symptom Onset ◽

Clinical Performance ◽

Point Of Care ◽

Community Setting ◽

Rt Pcr ◽

Chain Reaction ◽

False Negatives ◽

Polymerase Chain ◽

Antigen Tests ◽

Health Canada

Abstract BACKGROUND Point of Care SARS-CoV-2 antigen tests, such as the Abbott Panbio, have great potential to help combat the COVID-19 pandemic. The Panbio is Health Canada 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). We also prospectively evaluated results from assessment centres. For those individuals, an NP swab was collected for Panbio testing 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 poorer performance (throat sensitivity 57.7%, n = 61, and saliva sensitivity 2.6%, n = 41). NP swab sensitivity was 87.7% [n = 145, 95% confidence interval (CI) 81.0% − 92.7%]. There were 1,641 symptomatic individuals tested by Panbio in assessment centres, with 268/1641 (16.3%) positive for SARS-CoV-2. There were 37 false negatives and 2 false positives, corresponding to a sensitivity and specificity of 86.1% [95% CI 81.3% − 90.0%] and 99.9% [95% CI 99.5% − 100.0%], respectively. CONCLUSIONS The Panbio test reliably detects most cases of SARS-CoV-2 from adults in the 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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Assessment of CareStart G6PD rapid diagnostic test and CareStart G6PD biosensor in Mauritania

Infectious Diseases of Poverty ◽

10.1186/s40249-021-00889-2 ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Oum Kelthoum Mamadou Djigo ◽

Yacoub Ould Khalef ◽

Mohamed Salem Ould Ahmedou Salem ◽

Nicolas Gomez ◽

Leonardo Basco ◽

...

Keyword(s):

Diagnostic Test ◽

Rapid Diagnostic Test ◽

G6pd Deficiency ◽

Point Of Care ◽

False Negative ◽

Exact Test ◽

Qualitative Variables ◽

Males And Females ◽

Polymerase Chain ◽

Glucose 6 Phosphate Dehydrogenase

Abstract Background The elimination of Plasmodium vivax malaria requires 8-aminoquinolines, which are contraindicated in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency due to the risk of acute haemolytic anaemia. Several point-of-care devices have been developed to detect G6PD deficiency. The objective of the present study was to evaluate the performance of two of these devices against G6PD genotypes in Mauritania. Methods Outpatients were screened for G6PD deficiency using CareStart™ rapid diagnostic test (RDT) and CareStart™ G6PD biosensor in Nouakchott, Mauritania, in 2019–2020. African-type and Mediterranean-type G6PD genotypes commonly observed in Africa were determined by polymerase chain reaction-restriction fragment length polymorphism and sequencing. Qualitative variables were compared using Fisher’s exact test. Results Of 323 patients (74 males and 249 females), 5 males and 2 homozygous females had the African-type A- genotype: A−(202) in 3 males and 2 females and G6PD A−(968) in 2 males. Among heterozygous females, 13 carried G6PD A−(202), 12 G6PD A−(968), and 3 G6PD A−(542) variants. None had the Mediterranean-type G6PD genotype. Eight had a positive G6PD RDT result, including all 7 hemizygous males and homozygous females with A- or A-A- (0.12 to 2.34 IU/g haemoglobin, according to G6PD biosensor), but RDT performed poorly (sensitivity, 11.1% at the cut-off level of < 30%) and yielded many false negative tests. Thirty-seven (50.0%) males and 141 (56.6%) females were anaemic. The adjusted median values of G6PD activity were 5.72 and 5.34 IU/g haemoglobin in non-anaemic males (n = 35) and non-anaemic males and females (n = 130) with normal G6PD genotypes using G6PD biosensor, respectively. Based on the adjusted median of 5.34 IU/g haemoglobin, the performance of G6PD biosensor against genotyping was as follows: at 30% cut-off, the sensitivity and specificity were 85.7% and 91.7%, respectively, and at 80% cut-off, the sensitivity was 100% while the specificity was 64.9%. Conclusions Although this pilot study supports the utility of biosensor to screen for G6PD deficiency in patients, further investigation in parallel with spectrophotometry is required to promote and validate a more extensive use of this point-of-care device in areas where P. vivax is highly prevalent in Mauritania. Graphic abstract

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Comparison of Diagnostic Value of Rapid Diagnostic Test Standard Q towards Microscopic and Nested Polymerase Chain Reaction in Suspected Malaria Patients

International Journal of Pharmaceutical Research ◽

10.31838/ijpr/2020.12.04.206 ◽

2020 ◽

Vol 12 (04) ◽

Keyword(s):

Polymerase Chain Reaction ◽

Diagnostic Test ◽

Rapid Diagnostic Test ◽

Diagnostic Value ◽

Chain Reaction ◽

Nested Polymerase Chain Reaction ◽

Polymerase Chain

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Screening, Diagnostic and Prognostic Tests for COVID-19: A Comprehensive Review

Life ◽

10.3390/life11060561 ◽

2021 ◽

Vol 11 (6) ◽

pp. 561

Author(s):

Mariana Ulinici ◽

Serghei Covantev ◽

James Wingfield-Digby ◽

Apostolos Beloukas ◽

Alexander G. Mathioudakis ◽

...

Keyword(s):

Point Of Care ◽

Standard Test ◽

Current Evidence ◽

Molecular Testing ◽

Rt Pcr ◽

Diagnostic Screening ◽

Comprehensive Review ◽

Prognostic Tests ◽

Polymerase Chain ◽

Antigen Testing

While molecular testing with real-time polymerase chain reaction (RT-PCR) remains the gold-standard test for COVID-19 diagnosis and screening, more rapid or affordable molecular and antigen testing options have been developed. More affordable, point-of-care antigen testing, despite being less sensitive compared to molecular assays, might be preferable for wider screening initiatives. Simple laboratory, imaging and clinical parameters could facilitate prognostication and triage. This comprehensive review summarises current evidence on the diagnostic, screening and prognostic tests for COVID-19.

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Aeroallergen sensitisation for detecting asthma in primary care: a diagnostic test accuracy study

Clinical & Experimental Allergy ◽

10.1111/cea.13888 ◽

2021 ◽

Author(s):

Janwillem W.H. Kocks ◽

Heinze J.H. Andringa ◽

Ellen van Heijst ◽

Renaud Louis ◽

Inigo Ojanguren Arranz ◽

...

Keyword(s):

Primary Care ◽

Diagnostic Test ◽

Diagnostic Test Accuracy ◽

Test Accuracy ◽

Accuracy Study

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LAMP-based foldable microdevice platform for the rapid detection of Magnaporthe oryzae and Sarocladium oryzae in rice seed

Scientific Reports ◽

10.1038/s41598-020-80644-z ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

M. K. Prasannakumar ◽

P. Buela Parivallal ◽

Devanna Pramesh ◽

H. B. Mahesh ◽

Edwin Raj

Keyword(s):

Magnaporthe Oryzae ◽

Plant Pathogens ◽

Point Of Care ◽

Lamp Assay ◽

Rice Seed ◽

Highly Sensitive ◽

Polymerase Chain ◽

Rice Seeds ◽

Template Dna ◽

Assay Conditions

AbstractRice blast (caused by Magnaporthe oryzae) and sheath rot diseases (caused by Sarocladium oryzae) are the most predominant seed-borne pathogens of rice. The detection of both pathogens in rice seed is essential to avoid production losses. In the present study, a microdevice platform was designed, which works on the principles of loop-mediated isothermal amplification (LAMP) to detect M. oryzae and S. oryzae in rice seeds. Initially, a LAMP, polymerase chain reaction (PCR), quantitative PCR (qPCR), and helicase dependent amplification (HDA) assays were developed with primers, specifically targeting M. oryzae and S. oryzae genome. The LAMP assay was highly efficient and could detect the presence of M. oryzae and S. oryzae genome at a concentration down to 100 fg within 20 min at 60 °C. Further, the sensitivity of the LAMP, HDA, PCR, and qPCR assays were compared wherein; the LAMP assay was highly sensitive up to 100 fg of template DNA. Using the optimized LAMP assay conditions, a portable foldable microdevice platform was developed to detect M. oryzae and S. oryzae in rice seeds. The foldable microdevice assay was similar to that of conventional LAMP assay with respect to its sensitivity (up to 100 fg), rapidity (30 min), and specificity. This platform could serve as a prototype for developing on-field diagnostic kits to be used at the point of care centers for the rapid diagnosis of M. oryzae and S. oryzae in rice seeds. This is the first study to report a LAMP-based foldable microdevice platform to detect any plant pathogens.

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