EVALUATION OF PERFORMANCE OF NINE SEROLOGICALASSAYS FOR THE DETECTION OF SARS-COV-2 ANTIBODIES.

2021 ◽  
pp. 60-62
Author(s):  
Tagajdid Mohamed Rida ◽  
Konzi Clémence ◽  
El Kochri Safae ◽  
Elannaz Hicham ◽  
Abi Rachid ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Current Knowledge ◽  
False Negative ◽  
Antibody Test ◽  
Antibody Detection ◽  
Rt Pcr ◽  
Igg Antibody ◽  
Serological Tests ◽  
Blood Samples ◽  
Test Kit

Introduction: Currently, polymerase chain reaction (PCR) based viral RNAdetection is the standard for COVID-19 diagnosis [2]. Though, RNA testing based on throat or nasopharyngeal swabs has shown a number of false-negative results. Antibody detection tests have been developed to detect specic antibodies, IgM and IgG, to SRAS-CoV-2 virus. The clinical relevance of these tests is still under evaluation and is highly related to their clinical performance. Our objective is to assess analytical performances of nine SARS-CoV-2 antibodies immunoassays. Materiel and Method: We collected 80 blood samples from PCR-conrmed COVID-19 patients diagnosed in our Virology department (20 samples collected at day 10 after the onset of symptoms, 60 collected after day 14 following the onset of symptoms) and 20 blood samples from patients SARS-CoV-2 RT-PCR negative. All sera were tested with nine SARS-CoV-2 antibodies immunoassays ARCHITECT SARS-CoV-2 IgG® (Abbott), COVID-19 VIRCLIA® IgG MONOTEST (Vircell), COVID-19 VIRCLIA® IgM+IgA MONOTEST (Vircell), COVID-19 ELISA IgG® (Vircell), COVID-19 ELISA IgM+IgA® (Vircell), Elecsys® Anti-SARS-CoV-2 (Roche), FREND® COVID-19 IgG/IgM Duo (NanoEntek), COVID-PRESTO® (AAZ) and COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit® (Labnovation Technologies). Results: Sensitivity of tests increases once the seroconversion to anti-SARS-CoV-2 IgG positive in most individuals occurs toward the end of week 2 post-infection. COVID-19 PRESTO had the best accuracy in our study showing 100% sensitivity after day 14 following the onset of symptoms. All of the tests had a specicity of 100%. Conclusion: Serological tests are sensitive for the latest stages of COVID-19 infection. Recommendations on using SRAS-COV-2 antibody detection tests are continuously improving based on current knowledge of host antibody responses during infection. They are of great value in cases presenting COVID-19 symptoms with negative RT-PCR.

scholarly journals Evaluating ELISA, Immunofluorescence, and Lateral Flow Assay for SARS-CoV-2 Serologic Assays

2020 ◽  
Vol 11 ◽  
Author(s):  
Moïse Michel ◽  
Amar Bouam ◽  
Sophie Edouard ◽  
Florence Fenollar ◽  
Fabrizio Di Pinto ◽  
...  
Keyword(s):  
Rapid Test ◽  
Antibody Test ◽  
Immunofluorescence Assay ◽  
Lateral Flow ◽  
Antibody Detection ◽  
Rt Pcr ◽  
Igg Antibody ◽  
Reliable Determination ◽  
Test Kit ◽  
Serological Status

BackgroundThe SARS-CoV-2 outbreak has emerged at the end of 2019. Aside from the detection of viral genome with specific RT-PCR, there is a growing need for reliable determination of the serological status. We aimed at evaluating five SARS-CoV-2 serology assays.MethodsAn in-house immunofluorescence assay (IFA), two ELISA kits (EUROIMMUN® ELISA SARS-CoV-2 IgG and NovaLisa® SARS-CoV-2 IgG and IgM) and two lateral flow assays (T-Tek® SARS-CoV-2 IgG/IgM Antibody Test Kit and Sure Bio-tech® SARS-CoV-2 IgM/IgG Antibody Rapid Test) were compared on 40 serums from RT-PCR-confirmed SARS-CoV-2 infected patients and 10 SARS-CoV-2 RT-PCR negative subjects as controls.ResultsControl subjects tested negative for SARS-CoV-2 antibodies with all five systems. Estimated sensitivities varied from 35.5 to 71.0% for IgG detection and from 19.4 to 64.5% for IgM detection. For IgG, in-house IFA, EuroImmun, T-Tek and NovaLisa displayed 50–72.5% agreement with other systems except IFA vs EuroImmun and T-Tek vs NovaLisa. Intermethod agreement for IgM determination was between 30 and 72.5%.DiscussionThe overall intermethod agreement was moderate. This inconsistency could be explained by the diversity of assay methods, antigens used and immunoglobulin isotype tested. Estimated sensitivities were low, highlighting the limited value of antibody detection in CoVID-19.ConclusionComparison of five systems for SARS-CoV-2 IgG and IgM antibodies showed limited sensitivity and overall concordance. The place and indications of serological status assessment with currently available tools in the CoVID-19 pandemic need further evaluations.

scholarly journals The comparative superiority of IgM-IgG antibody test to real-time reverse transcriptase PCR detection for SARS-CoV-2 infection diagnosis

2020 ◽  
Author(s):  
Rui Liu ◽  
Xinghui Liu ◽  
Huan Han ◽  
Muhammad Adnan Shereen ◽  
Zhili Niu ◽  
...  
Keyword(s):  
Real Time ◽  
False Negative ◽  
Antibody Test ◽  
Pcr Detection ◽  
Antibody Detection ◽  
Rt Pcr ◽  
Igg Antibody ◽  
Positive Ratio ◽  
Infection Diagnosis ◽  
Significant Difference

AbstractBackgroundAs the increasing number of Corona Virus Disease 2019 (COVID-19) patients caused by the severe acute respiratory coronavirus 2 (SARS-CoV-2), which caused an outbreak initiated from Wuhan, China in December, 2019, the clinical features and treatment of COVID-19 patients have been understood. However, it is urgent to need the rapid and accurate detection for SARS-CoV-2 infection diagnosis. We aimed to evaluate the antibodies-based and nucleic acid-based tests (NAT) for SARS-CoV-2-infected patients.MethodWe retrospectively and observationally studied 133 patients diagnosed with SARS-CoV-2 and admitted in Renmin Hospital of Wuhan University, China, from Feb 17 to Mar 1, 2020. Demographic data, symptoms, clinical examination, laboratory tests, and clinical outcomes were collected. Data were compared between IgM-IgG antibody test and real-time RT-PCR detection for COVID-19 patients.ResultsOf 133 patients with SARS-CoV-2 infection, there were 44 moderate cases, 52 severe cases, and 37 critical cases with no significant difference of gender and age among three subgroups. Overall, the positive ratio in IgM antibody test was higher than in RT-PCR detection. In RT-PCR detection, the positive ratio was 65.91%, 71.15%, and 67.57% in moderate, severe, and critical cases, respectively. Whereas, the positive ratio of IgM/IgG antibody detection in patients was 79.55%/93.18%, 82.69%/100%, and 72.97%/97.30% in moderate, severe, and critical cases, respectively. Moreover, the concentrations of antibodies were also measured in three subgroups.ConclusionThe IgM-IgG antibodies-based test exhibited a comparative superiority to the NAT for COVID-19 diagnosis, which provides an effective complement to the false negative results from NAT for SARS-CoV-2 infection diagnosis.

scholarly journals Diagnostic Properties of Three SARS-CoV-2 Antibody Tests

Diagnostics ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 1441
Author(s):  
Suelen Basgalupp ◽  
Giovana dos Santos ◽  
Marina Bessel ◽  
Lara Garcia ◽  
Ana Carolina de Moura ◽  
...  
Keyword(s):  
Rapid Test ◽  
Epidemiological Studies ◽  
Antibody Detection ◽  
Sample Collection ◽  
Rt Pcr ◽  
Igg Antibody ◽  
Serological Tests ◽  
High Agreement ◽  
High Level ◽  
Antibody Tests

Serological assays emerged as complementary tools to RT-PCR in the diagnosis of SARS-CoV-2 as well as being needed for epidemiological studies. This study aimed to assess the performance of a rapid test (RT) compared to that of serological tests using finger prick blood samples. A total of 183 samples were evaluated, 88 of which were collected from individuals with negative RT-PCR and 95 from positive RT-PCR individuals. The diagnostic performance of RT (WONDFO®) and LUMIT (PROMEGA®) were compared to that of ELISA (EUROIMMUN®) for detecting antibodies against SARS-CoV-2 according to time from symptoms onset. The IgG antibody tests were detected in 77.4% (LUMIT), 77.9% (RT), and 80.0% (ELISA) of individuals. The detection of antibodies against SARS-CoV-2 increases in accordance with increasing time from symptoms onset. Considering only time from symptoms onset >21 days, the positivity rate ranged from 81.8 to 97.0% between the three tests. The RT and LUMIT showed high agreement with ELISA (agreement = 91.5%, k = 0.83, and agreement = 96.3%, k = 0.9, respectively) in individuals who had symptoms 15 to 21 days before sample collection. Compared to that of the ELISA assay, our results show sensitivity ranged from 95% to 100% for IgG antibody detection in individuals with symptoms onset between 15 and 21 days before sample collection. The specificity was 100% in individuals with symptoms onset >15 days before serological tests. This study shows good performance and high level of agreement of three immunoassays for the detection of SARS-CoV-2 antibodies.

scholarly journals Serological immunochromatographic approach in diagnosis with SARS-CoV-2 infected COVID-19 patients

2020 ◽  
Author(s):  
Yunbao Pan ◽  
Xinran Li ◽  
Gui Yang ◽  
Junli Fan ◽  
Yueting Tang ◽  
...  
Keyword(s):  
Real Time ◽  
Early Stage ◽  
False Negative ◽  
False Negative Rate ◽  
Intermediate Stage ◽  
Rt Pcr ◽  
Igg Antibody ◽  
Blood Samples ◽  
Icg Strip ◽  
Stage 1

AbstractAn outbreak of new coronavirus SARS-CoV-2 was occurred in Wuhan, China and rapidly spread to other cities and nations. The standard diagnostic approach that widely adopted in the clinic is nuclear acid detection by real-time RT-PCR. However, the false-negative rate of the technique is unneglectable and serological methods are urgently warranted. Here, we presented the colloidal gold-based immunochromatographic (ICG) strip targeting viral IgM or IgG antibody and compared it with real-time RT-PCR. The sensitivity of ICG assay with IgM and IgG combinatorial detection in nuclear acid confirmed cases were 11.1%, 92.9% and 96.8% at the early stage (1-7 days after onset), intermediate stage (8-14 days after onset), and late stage (more than 15 days), respectively. The ICG detection capacity in nuclear acid-negative suspected cases was 43.6%. In addition, the consistencies of whole blood samples with plasma were 100% and 97.1% in IgM and IgG strips, respectively. In conclusion, serological ICG strip assay in detecting SARS-CoV-2 infection is both sensitive and consistent, which is considered as an excellent supplementary approach in clinical application.

scholarly journals “Evaluation of a COVID-19 IgM and IgG Rapid Test and Assessment of Specific Antibody Response in COVID-19 patients, Tunisia 2020”

2021 ◽  
Author(s):  
letaief hejer ◽  
Sonia Dhaouadi ◽  
Aicha Hechaichi ◽  
Mouna Safer ◽  
Chahida Harizi ◽  
...  
Keyword(s):  
Antibody Response ◽  
Clinical Performance ◽  
Rapid Test ◽  
Antibody Test ◽  
Antibody Responses ◽  
Rt Pcr ◽  
Serological Tests ◽  
Clinical Sensitivity ◽  
Negative Results ◽  
Finger Stick

Abstract Background COVID-19 pandemic is a massive global health emergency. Although RT-PCR is the gold standard for diagnosing suspected cases, there is a need of serological tests to investigate antibody responses. Many serologic immunoassays have been developed to detect antibodies to SARS-CoV2, including rapid tests. This study assessed the clinical performance of the SARS-CoV-2 antibody test (colloidal gold immunochromatography, LEPU TECHNOLOGY) and evaluated the kinetic antibody response in COVID-19 patients.Methods: Samples collected by finger stick; obtained from RT-PCR confirmed cases and samples of negative controls were tested with the IgM/IgG Detection Kit . Results: The kit shows a clinical sensitivity of 65.7 % [59.7%-71.3%] and a specificity of 96.3% [93.0%-98.3%]. The predictive positive value and negative predictive value were respectively 95.2% [91.0%-97.8%] and 71.4% [66.1%-76.2%]. The seroconversion of specific IgM and IgG antibodies were observed as early as the 2nd day after symptom onset.Conclusions: This test is quite useful for assessing previous virus exposure, although negative results may be unreliable during the first weeks after infection. Longitudinal studies on antibody responses during and post infection are needed.

scholarly journals Comparative analysis of three point-of-care lateral flow immunoassays for detection of anti-SARS-CoV-2 antibodies in COVID-19 confirmed healthcare workers

2020 ◽  
Author(s):  
Danielle Dias Conte ◽  
Joseane Mayara Almeida Carvalho ◽  
Luciano Kleber de Souza Luna ◽  
Klinger Soares Faíco-Filho ◽  
Ana Helena Perosa ◽  
...  
Keyword(s):  
Healthcare Workers ◽  
Large Scale ◽  
Point Of Care ◽  
Antibody Test ◽  
Cost Effective ◽  
Lateral Flow ◽  
Rt Pcr ◽  
Serum Samples ◽  
Igg Antibody ◽  
Serological Tests

AbstractSince the Coronavirus Disease 2019 (COVID-19) pandemic, Brazil has the third-highest number of confirmed cases and the second-highest number of recovered patients. SARS-CoV-2 detection by real-time RT-PCR is the gold standard in certified infrastructured laboratories. However, for large-scale testing, diagnostics should be fast, cost-effective, widely available, and deployed for the community, such as serological tests based on lateral flow immunoassay (LFIA) for IgM/IgG detection. We evaluated three different commercial point-of-care (POC) LFIAs for anti-SARS-CoV-2 IgM and IgG detection in capillary whole blood of 100 healthcare workers (HCW) previously tested by RT-PCR: 1) COVID-19 IgG/IgM BIO (Bioclin, Brazil), 2) Diagnostic kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Livzon, China); and 3) SARS-CoV-2 Antibody Test (Wondfo, China). A total of 84 positives and 16 negatives HCW were tested. The data was also analyzed by the number of days post symptoms (DPS) in three groups: <30 (n=26), 30-59 (n=42), and >59 (n=16). Overall detection was 85.71%, 47.62%, and 44.05% for Bioclin, Livzon, and Wondfo, respectively, with a specificity of 100%, and 98.75% for Livzon on storage serum samples. Bioclin was more sensitive (p<0.01), regardless of the DPS. Thus, the Bioclin can be used as a POC test to monitor SARS-CoV-2 seroconversion in HCW.

scholarly journals Alternative or Complementary Role of Serological Rapid Antibody Test in the Management of Possible COVID-19 Cases

2020 ◽  
Author(s):  
Fatma Yildirim ◽  
Pinar Yildiz Gulhan ◽  
Ozlem Ercen Diken ◽  
Aylin Capraz ◽  
Meltem Simsek ◽  
...  
Keyword(s):  
Antibody Test ◽  
Test Method ◽  
Nasopharyngeal Swab ◽  
Common Symptom ◽  
Rt Pcr ◽  
Igg Antibody ◽  
Serological Tests ◽  
Female Ratio ◽  
The Mean ◽  
Rapid Antibody

Background: Although the gold diagnostic method for COVID-19 is accepted as the detection of viral particles by reverse transcription polymerase chain reaction (RT-PCR), serology testing for SARS-CoV-2 is at increased demand. A primary aim for utilization of serological tests are to better quantify the number of COVID-19 cases including those RT-PCR samples were negative but showing clinical and radiological signs of COVID-19. In this study, we aimed to report the features of the patients that were diagnosed and treated as possible COVID-19 cases whose multiple nasopharyngeal swab samples were negative by RT-PCR but serological IgM/IgG antibody against SARS-CoV-2 were detected by rapid antibody test. Method: We retrospectively analyzed eighty suspected COVID-19 cases that have at least two negative consecutive COVID-19 PCR test and were subjected to serological rapid antibody test. Result: The specific antibodies against SARS-CoV-2 were detected as positive in twenty-two patients. The mean age of patient group was 63.2+-13.1 years old with male /female ratio 11/11. Cough was the most common symptom with 90.9%. Most common presenting chest CT findings were bilateral ground glass opacities (77.2%) and alveolar consolidations (50.09%). The mean duration from symptom initiation to hospital admission, to hospitalization, to treatment initiation and to detection of antibody positivity were 8.6 +- 7.2, 11.2 +- 5.4, 7.9 +- 3.2 and 24 +- 17 days, respectively. Conclusion: Our study demonstrated the feasibility of COVID-19 diagnosis based on rapid antibody test in the cases of patients whose RT-PCR samples were negative. We suggest that the detection of antibodies against SARS-CoV-2 with rapid antibody test should be included in the diagnostic algorithm in suspected COVID-19 patients.

scholarly journals Evaluation of diagnostic accuracy of developed rapid SARS-COV-2 IgG antibody test kit using novel diluent system

VirusDisease ◽  
2021 ◽  
Author(s):  
Vani Maya ◽  
Jyothi Embekkat Kaviyil ◽  
Dinoop Koral Ponnambath ◽  
Renjith P. Nair ◽  
Anugya Bhatt ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Antibody Test ◽  
Igg Antibody ◽  
Test Kit

scholarly journals Incorporating false negative tests in epidemiological models for SARS-CoV-2 transmission and reconciling with seroprevalence estimates

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Rupam Bhattacharyya ◽  
Ritoban Kundu ◽  
Ritwik Bhaduri ◽  
Debashree Ray ◽  
Lauren J. Beesley ◽  
...  
Keyword(s):  
False Negative ◽  
Population Based ◽  
Training Data ◽  
Epidemiological Models ◽  
Rt Pcr ◽  
Antibody Prevalence ◽  
Igg Antibody ◽  
False Negatives ◽  
Seir Model ◽  
Study Population

AbstractSusceptible-Exposed-Infected-Removed (SEIR)-type epidemiologic models, modeling unascertained infections latently, can predict unreported cases and deaths assuming perfect testing. We apply a method we developed to account for the high false negative rates of diagnostic RT-PCR tests for detecting an active SARS-CoV-2 infection in a classic SEIR model. The number of unascertained cases and false negatives being unobservable in a real study, population-based serosurveys can help validate model projections. Applying our method to training data from Delhi, India, during March 15–June 30, 2020, we estimate the underreporting factor for cases at 34–53 (deaths: 8–13) on July 10, 2020, largely consistent with the findings of the first round of serosurveys for Delhi (done during June 27–July 10, 2020) with an estimated 22.86% IgG antibody prevalence, yielding estimated underreporting factors of 30–42 for cases. Together, these imply approximately 96–98% cases in Delhi remained unreported (July 10, 2020). Updated calculations using training data during March 15-December 31, 2020 yield estimated underreporting factor for cases at 13–22 (deaths: 3–7) on January 23, 2021, which are again consistent with the latest (fifth) round of serosurveys for Delhi (done during January 15–23, 2021) with an estimated 56.13% IgG antibody prevalence, yielding an estimated range for the underreporting factor for cases at 17–21. Together, these updated estimates imply approximately 92–96% cases in Delhi remained unreported (January 23, 2021). Such model-based estimates, updated with latest data, provide a viable alternative to repeated resource-intensive serosurveys for tracking unreported cases and deaths and gauging the true extent of the pandemic.

Evaluation of a Rapid Immunochromatographic test kit to the Gold Standard Fluorescent Antibody test for diagnosis of rabies in animals in Bhutan 

2020 ◽  
Author(s):  
Tenzin Tenzin ◽  
Kelzang Lhamo ◽  
Purna B Rai ◽  
Dawa Tshering ◽  
Pema Jamtsho ◽  
...  
Keyword(s):  
Predictive Value ◽  
Fluorescent Antibody ◽  
False Negative ◽  
Rapid Test ◽  
Antibody Test ◽  
Reference Standard ◽  
Predictive Values ◽  
Percent Agreement ◽  
Test Kit ◽  
Resource Poor

Abstract Background: Rabies kills approximately 59,000 people in the world each year worldwide. Rapid and accurate diagnosis of rabies is important for instituting rapid containment measures and for advising the exposed people for postexposure treatment. The application of a rapid diagnostic tests in the field can greatly enhance disease surveillance and diagnostic activities, especially in resource poor settings. In this study, a total of 179 brain tissue samples collected from different rabies suspect animal species (113 dogs, 50 cattle, 10 cats, 3 goats, 2 horses, and 1 bear) were selected and tested using both rapid immunochromatographic kit and the reference standard fluorescent antibody test (FAT). We evaluated the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of a rapid antigen detection test kit produced by BioNote, Inc. (Hwaseong-si, Korea) relative to a FAT for its fit-for-purpose for confirmation of clinical cases of rabies for early response and enhancing rabies surveillance. Results: Among 179 samples examined in this study, there was a concordance in results by the rapid test and FAT in 115 positive samples and 54 negative samples. Test results were discordant in 10 samples which were positive by FAT, but negative (false negative) by rapid kit. The rapid test kit showed a sensitivity of 92% (95% CI: 85.9 – 95.6) and specificity of 100% (95% CI: 93.4 – 100) using FAT as the reference standard. The positive and negative predictive values were found to be 100% (95% CI:96.7 – 100) and 84.4% (95% CI: 73.6 – 91.3), respectively. Overall, there was 94.4% (95% CI: 90 – 96.9) test agreement between rapid test and FAT (Kappa value = 0.874) with a positive percent agreement and negative percent agreement of 92 and 100%, respectively. Conclusions: Our finding demonstrated that the rapid test kit (BioNote) can be used for rabies surveillance and confirming clinical case of rabies in animals for making rapid decisions particularly controlling rabies outbreaks in resource poor settings.

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