scholarly journals Analytical performance of the point-of-care BIOSYNEX COVID-19 Ag BSS for the detection of SARS‐CoV‐2 nucleocapsid protein in nasopharyngeal swabs: a prospective field evaluation during the COVID-19 third wave in France

Infection ◽  
2021 ◽  
Author(s):  
Frédéric Fitoussi ◽  
Serge Tonen-Wolyec ◽  
Natalio Awaida ◽  
Raphaël Dupont ◽  
Laurent Bélec
Keyword(s):  
Predictive Value ◽  
Nucleocapsid Protein ◽  
Point Of Care ◽  
High Sensitivity ◽  
Field Evaluation ◽  
Analytical Performance ◽  
N Gene ◽  
Youden Index ◽  
Rt Pcr ◽  
Viral Excretion

Abstract Background The accuracy and reliability of rapid diagnostic tests are critical for monitoring and diagnosing SARS-CoV-2 infection in the general population. This study aimed to evaluate the analytical performance of the BIOSYNEX COVID-19 Ag BSS (Biosynex Swiss SA, Fribourg, Switzerland) antigen rapid diagnostic test (BIOSYNEX Ag-RDT), which targets the SARS-CoV-2 N-nucleocapsid protein for the diagnosis of COVID-19. The Ag-RDT was compared with a real-time RT-PCR (rtRT-PCR) as gold standard for performance measurement. Methods Two nasopharyngeal flocked swabs were prospectively collected simultaneously in March and April 2021 from 967 individuals aged ≥ 18 years tested for SARS-CoV-2 in two private laboratories, Paris, France. Results Overall, the Ag-RDT demonstrated high sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 81.8%, 99.6%, 96.6%, and 97.5%, respectively. The agreement (97.0%), reliability assessed using Cohen’s κ-coefficient (0.87), and accuracy evaluated using Youden index (J) (81.6%) in detecting SARS-CoV-2 were high. The analytical performance of the Ag-RDT remained high when there was significant viral shedding (i.e., N gene Ct values ≤ 33 on reference RT-PCR). The sensitivity was only 55.2% in case of low or very low viral excretion (Ct > 33). Conclusions The BIOSYNEX Ag-RDT is a promising, potentially simple diagnostic tool, especially in symptomatic COVID-19 patients with substantial viral excretion in the nasopharynx.

scholarly journals Analytical Performance of the Point-of-care BIOSYNEX COVID-19 Ag BSS for the Detection of SARS‐CoV‐2 Nucleocapsid Protein in Nasopharyngeal Swabs: A Prospective Field Evaluation During the COVID-19 Third Wave in France

2021 ◽  
Author(s):  
Frédéric Fitoussi ◽  
Serge Tonen-Wolyec ◽  
Natalio Awaida ◽  
Raphaël Dupont ◽  
Laurent Belec
Keyword(s):  
Predictive Value ◽  
Nucleocapsid Protein ◽  
Point Of Care ◽  
Field Evaluation ◽  
Analytical Performance ◽  
N Gene ◽  
Youden Index ◽  
Rt Pcr ◽  
Perfect Agreement ◽  
Viral Excretion

Abstract Background: The accuracy and reliability of rapid diagnostic tests are critical for monitoring and diagnosing SARS-CoV-2 infection in the general population. This study aimed to evaluate the analytical performance of the BIOSYNEX COVID-19 Ag BSS (Biosynex Swiss SA, Fribourg, Switzerland) antigen rapid diagnostic test (Ag-RDT), which targets the SARS-CoV-2 N-nucleocapsid protein for the diagnosis of COVID-19. The Ag-RDT was compared with a real-time RT-PCR (rtRT-PCR) gold standard for performance measurement.Methods: Two nasopharyngeal flocked swabs were prospectively collected simultaneously in March and April 2021 from 967 individuals aged ≥18 years tested for SARS-CoV-2 in two private laboratories, Paris, France.Results: Overall, the Ag-RDT demonstrated high sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 81.8%, 99.6%, 96.6%, and 97.5%, respectively, as well as high or near-perfect agreement (97.0%), reliability was assessed using Cohen’s κ-coefficient (0.87), and accuracy was evaluated using Youden index (J) (81.6%) in detecting SARS-CoV-2. The analytical performance of the Ag-RDT remained high when there was significant viral shedding (i.e., N gene Ct values ≤ 33 on reference RT-PCR). The sensitivity was only 55.2% in case of low or very low viral excretion (Ct> 33).Conclusions: The BIOSYNEX COVID-19 Ag BSS Ag-RDT is a promising, potentially simple diagnostic tool, especially in symptomatic COVID -19 or proven infectiousness.

scholarly journals Analytical Performances of the Point-of-Care BIOSYNEX COVID-19 Ag BSS for the Detection of SARS‐CoV‐2 Nucleocapsid Protein in Nasopharyngeal Swabs: A Prospective Field Evaluation During the COVID-19 Third Wave in France

2021 ◽  
Author(s):  
Fréderic Fitoussi ◽  
Serge Tonen-Wolyec ◽  
Natalio Awaida ◽  
Raphael Dupont ◽  
Laurent Belec
Keyword(s):  
Nucleocapsid Protein ◽  
Point Of Care ◽  
Diagnostic Testing ◽  
High Sensitivity ◽  
High Specificity ◽  
Field Evaluation ◽  
N Gene ◽  
Third Wave ◽  
Perfect Agreement ◽  
Viral Excretion

Abstract Background: Evaluating the accuracy and reliability of rapid diagnostic testing kits is crucial for surveillance and diagnosis of SARS-CoV-2 infections in general population. The aim of the study was to assess the analytical performances of the antigen-rapid diagnosis test (Ag-RDT) BIOSYNEX COVID-19 Ag BSS (Biosynex Swiss SA, Freiburg, Switzerland), targeting the SARS-CoV-2 N nucleocapsid protein, for the diagnosis of COVID-19, by reference to real-time RT-PCR (rtRT-PCR).Methods: A total 967 adults living in Paris region were prospectively included during the third wave of the COVID-19 epidemic in France. Paired nasopharyngeal flocked swabs were collected at the same timepoint from persons aged ≥18 years receiving testing for SARS-CoV-2, at two private laboratories.Results: Overall, the Ag-RDT showed high sensitivity, specificity, PPV and NPV of 81.8%, 99.6%, 96.6% and 97.5%, respectively, as well as high or almost perfect agreement (97.0%), reliability assessed by Cohen’s κ coefficient (0.87), and accuracy assessed by Youden’s J index (81.6%) to detect SARS-CoV-2. The analytical performances of the Ag-RDT remained high in the event of significant viral excretion (i.e., N gene Ct values ≤ 33 by reference rtRT-PCR), while the sensitivity of the Ag-RDT dropped to 55.2% with low or very low viral shedding (Ct> 33).Conclusions: The Ag-RDT BIOSYNEX COVID-19 Ag BSS showed high specificity and sufficient sensitivity for the detection of SARS-CoV-2. This test is a promising potential easy diagnostic tool, especially in situations of symptomatic COVID-19 and/or proven contagiousness.

scholarly journals A rapid, high-sensitivity SARS-CoV-2 nucleocapsid immunoassay to aid diagnosis of acute COVID-19 at the point of care

2020 ◽  
Author(s):  
Paul K. Drain ◽  
Madhavi Ampajwala ◽  
Christopher Chappel ◽  
Andre B. Gvozden ◽  
Melanie Hoppers ◽  
...  
Keyword(s):  
Real Time ◽  
Symptom Onset ◽  
Real Time Pcr ◽  
Nucleocapsid Protein ◽  
Point Of Care ◽  
High Sensitivity ◽  
Antigen Test ◽  
Rt Pcr ◽  
Duration Of Symptoms ◽  
Microfluidic Immunoassay

AbstractBackgroundThe LumiraDx SARS-CoV-2 antigen test, which uses a high-sensitivity, microfluidic immunoassay to detect the nucleocapsid protein of SARS-CoV-2, was evaluated for diagnosing acute COVID-19 in adults and children across point-of-care settings.MethodsTwo paired anterior nasal swabs or two paired nasopharyngeal swabs were collected from each participant. Swabs were tested by the LumiraDx SARS-CoV-2 antigen test and compared with real-time PCR (rt-PCR; Roche cobas 6800 platform). Positive- and negative predictive values and likelihood ratios were calculated. Results stratified based on gender, age, duration of symptoms, and rt-PCR cycle threshold.ResultsOut of the 512 participants, aged 0-90 years, of this prospective validation study, 414 (81%) were symptomatic for COVID-19 and 123 (24%) swabs were positive for SARS-CoV-2 based on rt-PCR testing. Compared with rt-PCR, the 12-minute swab test had 97.6% sensitivity and 96.6% specificity within 12 days of symptom onset, representing the period of infectivity. All (100%) samples detected within 33 rt-PCR cycles were also identified using the antigen test. Results were consistent across age and gender. Despite being performed by minimally trained healthcare workers, the user error rate of the test system was 1%.ConclusionThe rapid high-sensitivity assay using nasopharyngeal or anterior nasal sampling may offer significant improvements for diagnosing acute SARS-CoV-2 infection in clinic- and community-based settings.SummaryA 12-minute nasal swab test detects 97.6% of COVID-19 infections, compared to gold standard real-time PCR testing, up to 12 days following symptom onset using a microfluidic immunoassay for SARS-CoV-2 nucleocapsid protein.

EXPRESS: Analytical characterization and clinical performance evaluation of a new point-of-care testing system for high-sensitivity cardiac troponin I assay

2021 ◽  
pp. 000456322110276
Author(s):  
Rui Zhang ◽  
Yuhong Yue ◽  
Jie Shi ◽  
Rui Zhao ◽  
Yichuan Song ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Predictive Value ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Point Of Care ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
Analytical Performance ◽  
Point Of Care Testing ◽  
Limit Of Quantitation

Background: We aimed to evaluate the analytical performance and clinical diagnostic accuracy of the SuperFlex point-of-care testing (POCT) High-Sensitivity Cardiac Troponin I (hs-cTnI) assay system. Method: The imprecision, the limit of blank (LoB), the limit of detection (LoD), the limit of quantitation (LoQ), linearity, and comparability were assessed as per the Clinical and Laboratory Standards Institute guidelines. Also, the 99th-percentile reference value and diagnostic accuracy were evaluated. Results: The reproducibility and total imprecision were 1.52–1.92% and 2.69–2.92%, respectively. LoB and LoD were 1ng/L and 1.8ng/L, respectively, and LoQ was 12ng/L at 10% coefficient of variation (CV). The results met the requirements of linearity, and the correlation coefficient was 0.996. The SuperFlex POCT results had good agreement with those obtained by the Siemens Advia 2400. The CV% was 7.24% at the 99th percentile concentration (p99th) of 25.6ng/L (95% confidence interval: 22.0–33.3ng/L) from 620 healthy populations. The sex-partitioned CV% and p99th were 7.15% at 27ng/L (males; n = 308) and 7.35% at 24ng/L (females; n = 312), respectively (p < 0.0001). The hs-cTnI detection rate of all observed healthy individuals from LoD to 99th was 82.57% by the SuperFlex POCT assay, 89.90% for the males, and 75.48% for the females. The sensitivity, specificity, positive predictive value, and negative predictive value of diagnostic performance for acute myocardial infarction were 100%, 81.25%, 57%, and 100%, respectively. Conclusions: The SuperFlex POCT system showed the analytical performance characteristics required for enabling the clinical use of a hs-cTnI assay.

scholarly journals Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2

Viruses ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1043
Author(s):  
Tove Hoffman ◽  
Linda Kolstad ◽  
Bengt Rönnberg ◽  
Åke Lundkvist
Keyword(s):  
Predictive Value ◽  
Serological Test ◽  
Point Of Care ◽  
External Validation ◽  
High Sensitivity ◽  
Lateral Flow ◽  
Spike Protein ◽  
Individual Level ◽  
Lateral Flow Test ◽  
Production Errors

The potential of rapid point-of-care (POC) tests has been subject of doubt due to an eventual risk of production errors. The aim was therefore to evaluate the two separate production lots of a commercial POC lateral flow test, intended for the detection of IgM and IgG against the SARS-CoV-2 spike protein (S1). Control samples consisted of serum from individuals with confirmed SARS-CoV-2 infection and pre-COVID-19 negative sera gathered from a biobank. The presence of anti-S1 IgM/IgG in the sera was verified by an in-house Luminex-based serological assay (COVID-19 SIA). One hundred samples were verified as positive for anti-S1 IgG and 74 for anti-S1 IgM. Two hundred samples were verified as negative for anti-S1 IgM/IgG. For the two lots of the POC-test, the sensitivities were 93.2% and 87.8% for IgM and 93.0% and 100% for IgG. The specificities were 100% for IgM and 99.5% for IgG. The positive predictive value was 100% for IgM and 98.9% and 99.0% for IgG. The negative predictive value was 97.6% and 95.7% for IgM, and 96.6% and 100% for IgG. The evaluated POC-test is suitable to assess anti-SARS-CoV-2 S1 IgM and IgG, as a measure of previous virus exposure on an individual level. The external validation of separate lots of rapid POC-tests is encouraged to ensure high sensitivity before market introduction.

scholarly journals Integrating high-performing electrochemical transducers in lateral flow assay

2021 ◽  
Author(s):  
Antonia Perju ◽  
Nongnoot Wongkaew
Keyword(s):  
High Performance ◽  
Point Of Care ◽  
Low Cost ◽  
High Sensitivity ◽  
Lateral Flow ◽  
Analytical Performance ◽  
Label Free ◽  
High Performing ◽  
Lateral Flow Assays ◽  
Electrochemical Transducers

AbstractLateral flow assays (LFAs) are the best-performing and best-known point-of-care tests worldwide. Over the last decade, they have experienced an increasing interest by researchers towards improving their analytical performance while maintaining their robust assay platform. Commercially, visual and optical detection strategies dominate, but it is especially the research on integrating electrochemical (EC) approaches that may have a chance to significantly improve an LFA’s performance that is needed in order to detect analytes reliably at lower concentrations than currently possible. In fact, EC-LFAs offer advantages in terms of quantitative determination, low-cost, high sensitivity, and even simple, label-free strategies. Here, the various configurations of EC-LFAs published are summarized and critically evaluated. In short, most of them rely on applying conventional transducers, e.g., screen-printed electrode, to ensure reliability of the assay, and additional advances are afforded by the beneficial features of nanomaterials. It is predicted that these will be further implemented in EC-LFAs as high-performance transducers. Considering the low cost of point-of-care devices, it becomes even more important to also identify strategies that efficiently integrate nanomaterials into EC-LFAs in a high-throughput manner while maintaining their favorable analytical performance.

scholarly journals Diagnosis of SARS-Cov-2 Infection by RT-PCR Using Specimens Other Than Naso- and Oropharyngeal Swabs: A Systematic Review and Meta-Analysis

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 363
Author(s):  
Vânia M. Moreira ◽  
Paulo Mascarenhas ◽  
Vanessa Machado ◽  
João Botelho ◽  
José João Mendes ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Performance ◽  
Point Of Care ◽  
Meta Analysis ◽  
High Sensitivity ◽  
Nasopharyngeal Swab ◽  
Sample Collection ◽  
Rt Pcr ◽  
Oropharyngeal Swab ◽  
Nucleic Acid Assays

The rapid and accurate testing of SARS-CoV-2 infection is still crucial to mitigate, and eventually halt, the spread of this disease. Currently, nasopharyngeal swab (NPS) and oropharyngeal swab (OPS) are the recommended standard sampling techniques, yet, these have some limitations such as the complexity of collection. Hence, several other types of specimens that are easier to obtain are being tested as alternatives to nasal/throat swabs in nucleic acid assays for SARS-CoV-2 detection. This study aims to critically appraise and compare the clinical performance of RT-PCR tests using oral saliva, deep-throat saliva/posterior oropharyngeal saliva (DTS/POS), sputum, urine, feces, and tears/conjunctival swab (CS) against standard specimens (NPS, OPS, or a combination of both). In this systematic review and meta-analysis, five databases (PubMed, Scopus, Web of Science, ClinicalTrial.gov and NIPH Clinical Trial) were searched up to the 30th of December, 2020. Case-control and cohort studies on the detection of SARS-CoV-2 were included. The methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS 2). We identified 1560 entries, 33 of which (1.1%) met all required criteria and were included for the quantitative data analysis. Saliva presented the higher accuracy, 92.1% (95% CI: 70.0–98.3), with an estimated sensitivity of 83.9% (95% CI: 77.4–88.8) and specificity of 96.4% (95% CI: 89.5–98.8). DTS/POS samples had an overall accuracy of 79.7% (95% CI: 43.3–95.3), with an estimated sensitivity of 90.1% (95% CI: 83.3–96.9) and specificity of 63.1% (95% CI: 36.8–89.3). The remaining index specimens could not be adequately assessed given the lack of studies available. Our meta-analysis shows that saliva samples from the oral region provide a high sensitivity and specificity; therefore, these appear to be the best candidates for alternative specimens to NPS/OPS in SARS-CoV-2 detection, with suitable protocols for swab-free sample collection to be determined and validated in the future. The distinction between oral and extra-oral salivary samples will be crucial, since DTS/POS samples may induce a higher rate of false positives. Urine, feces, tears/CS and sputum seem unreliable for diagnosis. Saliva testing may increase testing capacity, ultimately promoting the implementation of truly deployable COVID-19 tests, which could either work at the point-of-care (e.g. hospitals, clinics) or at outbreak control spots (e.g., schools, airports, and nursing homes).

scholarly journals Structured reporting of chest CT provides high sensitivity and specificity for early diagnosis of COVID-19 in a clinical routine setting

2021 ◽  
Vol 94 (1117) ◽  
pp. 20200574
Author(s):  
Alexander Gross ◽  
Georg Heine ◽  
Martin Schwarz ◽  
Dorina Thiemig ◽  
Sven Gläser ◽  
...  
Keyword(s):  
Early Diagnosis ◽  
Predictive Value ◽  
High Sensitivity ◽  
Pulmonary Involvement ◽  
Chest Ct ◽  
Structured Reporting ◽  
Rt Pcr ◽  
Clinical Routine ◽  
Dominant Feature ◽  
Routine Clinical Setting

Objectives: Although chest CT has been widely used in patients with COVID-19, its role for early diagnosis of COVID-19 is unclear. We report the diagnostic performance of chest CT using structured reporting in a routine clinical setting during the early phase of the epidemic in Germany. Methods: Patients with clinical suspicion of COVID-19 and moderate-to-severe symptoms were included in this retrospective study. CTs were performed and reported before RT-PCR results (reference standard) became available. A structured reporting system was used that concluded in a recently described five-grade score (“CO-RADS”), indicating the level of suspicion for pulmonary involvement of COVID-19 from 1 = very low to 5 = very high. Structured reporting was performed by three Radiologists in consensus. Results: In 96 consecutive patients (50 male, mean age 64), RT-PCR was positive in 20 (21%) cases. CT features significantly more common in RT-PCR-positive patients were ground-glass opacities as dominant feature, crazy paving, hazy margins of opacities, and multifocal bilateral distribution (p < 0.05). Using a cut-off point between CO-RADS 3 and 4, sensitivity was 90%, specificity 91%, positive predictive value 72%, negative predictive value 97%, and accuracy 91%. ROC analysis showed an AUC of 0.938. Conclusions: Structured reporting of chest CT with a five-grade scale provided accurate diagnosis of COVID-19. Its use was feasible and helpful in clinical routine. Advances in knowledge: Chest CT with structured reporting may be a provisional diagnostic alternative to RT-PCR testing for early diagnosis of COVID-19, especially when RT-PCR results are delayed or test capacities are limited.

scholarly journals TUBERCULOUS PERICARDITIS AND PLEURITIS;

2017 ◽  
Vol 24 (05) ◽  
pp. 656-664
Author(s):  
Hamid Mahmood ◽  
Talmeez Zaib ◽  
Zafar Hayat Maken ◽  
Ammara Waqar ◽  
Yasir Hassan ◽  
...  
Keyword(s):  
Negative Predictive Value ◽  
Predictive Value ◽  
Point Of Care ◽  
High Sensitivity ◽  
Smear Microscopy ◽  
Diagnostic Validity ◽  
Standard Material ◽  
Point Of Care Test ◽  
Resource Limited ◽  
Attractive Point

Background: Diagnosis of Tubercles Pericarditis and Pleuritis remains thegreatest challenge for clinicians. WHO has recommended GeneXpert MTB/RIF assay as ascreening test for substitution of conventional methods for the initial diagnosis and prognosisof the extra pulmonary and pulmonary tuberculosis in developing countries. Objectives: Tofind out the diagnostic validity of GeneXpert assay for detection of Myco-bacterium tuberculosisin the pericardial and pleural effusions samples, keeping MTB culture as “Gold Standard”.Material and Methods: Total number of 286 samples of effusions (pericardial 128, pleural 158)were received, and processed for Zn smear microscopy, LJ culture, GeneXpert MTB/RIF assayaccording standard protocols. Efficacy for the detection of MTB was evaluated comparatively.Results: Out of 286effusions samples AFB was detected by Zn smear in 11 (3.8%) samples whileGeneXpert detected MTB in 43 (15.0%) and LJ culture 51 (17.8%). Zn smear showed sensitivity18.2%, specificity, 98.1%, Positive predictive value 81.8%, Negative predictive value 85.4 %, incomparison GeneXpert showed high sensitivity 84.3%, specificity 100%, with Positive predictivevalue 100%, and Negative predictive value 96.7%. Conclusion: GeneXpert assay is innovativetool in resource limited settings for prompt detection of MTB along with drug résistance. It isdefinitely an attractive point of care test, with High sensitivity and specificity along with turnouttime of two hours which facilitates timely diagnoses and appropriate management of tuberclePleuritis and Pericarditis.

scholarly journals Clinical Evaluation of a COVID-19 Antibody Lateral Flow Assay using Point of Care Samples

2020 ◽  
Author(s):  
Won Lee ◽  
Steven Straube ◽  
Ryan Sincic ◽  
Jeanne A. Noble ◽  
Juan Carlos Montoy ◽  
...  
Keyword(s):  
Predictive Value ◽  
Point Of Care ◽  
Acute Infection ◽  
High Specificity ◽  
Lateral Flow ◽  
Lateral Flow Immunoassay ◽  
Onset Date ◽  
Rt Pcr ◽  
Serum Samples ◽  
Antibody Positivity

ABSTRACTIntroductionThe ongoing SARS-CoV-2 pandemic has spurred the development of numerous point of care (PoC) immunoassays. Assessments of performance of available kits are necessary to determine their clinical utility. Previous studies have mostly performed these assessments in a laboratory setting, which raises concerns of translating findings for PoC use. The aim of this study was to assess the performance of a lateral flow immunoassay for the detection of SARS-CoV-2 antibodies using samples collected at PoC.MethodOne lateral flow immunoassay (Humasis® COVID-19 IgG/IgM) was tested. In total, 50 PCR RT-PCR positive and 52 RT-PCR negative samples were collected at PoC. Fifty serum specimens from Dec 2018 to Feb 2019 were used as controls for specificity. Serum samples collected between Dec 2019 to Feb 2020 were used as additional comparators. Clinical data including symptom onset date was collected from patient history and the medical record.ResultsThe overall sensitivity for the kit was 74% (95% CI: 59.7% -85.4%). The sensitivity for IgM and IgG detection >14 days after date of onset was 88% (95% CI: 68.8% -97.5%) and 84% (95% CI: 63.9% – 95.5%), with a negative predictive value (NPV) of 94% for IgM (95% CI: 83.5% - 98.8%) and 93% for IgG (95% CI: 81.8% - 97.9%). The overall specificity was 94% (95% CI: 83.5% - 98.8%). The Immunoglobulin specific specificity was 94% for IgM (95% CI: 83.5% - 98.8%) and 98% for IgG (95% CI: 89.4% - 100.0%), with a positive predictive value (PPV) of 88% for IgM (95% CI: 68.8% - 97.5%) and 95% for IgG (95% CI: 77.2% - 99.9%) respectively for samples collected from patients >14 days after date of onset. Specimen collected during early phase of COVID-19 pandemic (Dec 2019 to Feb 2020) showed 11.8% antibody positivity, and 11.3% of PCR-negative patients demonstrated antibody positivity.DiscussionHumasis® COVID-19 IgG/IgM LFA demonstrates greater than 90% PPV and NPV for samples collected 14 days after the onset of symptoms using samples collected at PoC. While not practical for the diagnosis of acute infection, the use of the lateral flow assays with high specificity may have utility for determining seroprevalence or seroconversion in longitudinal studies.

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