scholarly journals Evaluation of the Abbott Architect, Roche Elecsys and Virtus S1 SARS-CoV-2 antibody tests in community-managed COVID-19 cases

Author(s):  
Sebastian L. Johnston ◽  
Paul F McKay ◽  
Tatiana Kebadze ◽  
Kai Hu ◽  
Karnyart Samnuan ◽  
...  

AbstractBackgroundAntibody testing can help define how protective immunity to SARS-CoV-2 is and how long this immunity lasts. Many antibody tests have been evaluated in hospitalised rather than community based COVID-19 cases. Virtus Respiratory Research Ltd (Virtus) has developed its own quantitative IgM and IgG SARS CoV-2 antibody assay. We report its validation and performance characteristics and compare its performance with the Abbott Architect and Roche Elecsys assays in community COVID cases.MethodsWe developed a quantitative antibody test to detect IgM and IgG to the SARS-CoV-2 S1 spike protein (the Virtus test) and validated this test in 107 “true positive” sera from 106 community-managed and 1 hospitalised COVID-19 cases and 208 “true negative” serum samples. We validated the Virtus test against a neutralising antibody test. We determined sensitivities of the Abbott test in the 107 true positive samples and the Roche test in a subset of 75 true positive samples.ResultsThe Virtus quantitative test was positive in 93 of 107 (87%) community cases of COVID-19 and both IgM and IgG levels correlated strongly with neutralising antibody titres (r=0.75 for IgM, r=0.71 for IgG, P<0.0001 for both antibodies). The specificity of the Virtus test was 98.6% for low level antibody positives, 99.5% for moderate positives and 100% for high or very high positives. The Abbott test had a sensitivity of 68%. In the 75 sample subset, the Virtus test was positive in 91%, the Roche test in 69%.ConclusionsThe Abbott and Roche tests had sensitives of 68% and 69% respectively in this community set of COVID-19 sera, while the Virtus test had sensitivities of 87% and 91% in the same sample sets. The strong positive correlation with virus neutralization suggests a positive Virtus quantitative antibody test is likely predictive of protective against recurrent COVID-19.FundingThe development of the Virtus test and sample testing with all antibody tests was funded by Virtus Respiratory Research Ltd. The research studies providing 111 of the 208 of the “true negative” samples was supported by MRC Grant numbers MR/M025330/1 and G1100238 and by the National Institute of Health Research (NIHR) Imperial Biomedical Research Centre (BRC), SLJ is a NIHR Emeritus Senior Investigator and is funded in part by European Research Council Advanced Grant 788575 and the Asthma UK Clinical Chair (grant CH11SJ). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

2021 ◽  
Vol 8 ◽  
Author(s):  
Brendan O'Kelly ◽  
Ronan McLaughlin ◽  
Roseann O'Doherty ◽  
Hailey Carroll ◽  
Roisin Murray ◽  
...  

Objective: We aimed to use SARS-CoV-2 antibody tests to assess the asymptomatic seroprevalence of individuals in high-risk hospital cohorts who's previous COVID-19 exposure is unknown; staff, and patients requiring haemodialysis or chemotherapy after the first wave.Methods: In a single Center, study participants had five SARS-CoV-2 antibody tests done simultaneously; one rapid diagnostic test (RDT) (Superbio Colloidal Gold IgM/IgG), and four laboratory tests (Roche Elecsys® Anti-SARS-CoV-2 IgG [RE], Abbott Architect i2000SR IgG [AAr], Abbott Alinity IgG [AAl], and Abbott Architect IgM CMIA). To determine seroprevalence, only positive test results on laboratory assay were considered true positives.Results: There were 157 participants, of whom 103 (65.6%) were female with a median age of 50 years (range 19–90). The IgG component of the RDT showed a high number of false positives (n = 18), was inferior to the laboratory assays (p &lt; 0.001 RDT vs. AAl/AAr, p &lt; 0.001 RDT vs. RE), and had reduced specificity (85.5% vs. AAl/AAr, 87.2% vs. RE). Sero-concordance was 97.5% between IgG laboratory assays (RE vs. AAl/AAr). Specificity of the IgM component of the RDT compared to Abbott IgM CMIA was 95.4%. Ten participants had positivity in at least one laboratory assay, seven (9.9%) of which were seen in HCWs. Two (4.1%) hematology/oncology (H/O) patients and a single (2.7%) haemodialysis (HD) were asymptomatically seropositive. Asymptomatic seroprevalence of HCWs compared to patients was not significant (p = 0.105).Conclusion: HCWs (9.9%) had higher, although non-significant asymptomatic seroprevalence of SARS-CoV-2 antibodies compared to high-risk patients (H/O 4.1%, HD 2.7%). An IgM/IgG rapid diagnostic test was inferior to laboratory assays. Sero-concordance of 97.5% was found between IgG laboratory assays, RE vs. AAl/AAr.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S849-S850
Author(s):  
David McCormick ◽  
Tracy Scott ◽  
Jesse Chavez ◽  
Kay Wilcox ◽  
Grace E Marx ◽  
...  

Abstract Background The COVID-19 pandemic has disproportionately affected people experiencing homelessness (PEH) residing in shelters. Initial and regular testing of PEH in communities with moderate or substantial SARS-CoV-2 transmission may limit spread in shelters. We analyzed factors associated with positive SARS-CoV-2 RNA and antibody tests for PEH staying in shelters or encampments in Denver, Colorado. Methods In May 2020, Denver Public Health collaborated with local leaders to identify 4 homeless shelters and 3 outdoor encampments for voluntary, universal SARS-CoV-2 testing. At each testing event, a short questionnaire including sociodemographic factors and symptoms was administered to PEH who consented to testing. SARS-CoV-2 RNA testing by reverse transcription polymerase chain reaction (RT-PCR) was performed on nasopharyngeal swabs; antibody testing was performed on venous blood samples. PEH reporting a prior positive RT-PCR test were not retested but were eligible for antibody testing. Statistical calculations were performed with an α of 0.05; all tests were two-sided. Results From June 2–July 28, 2020, 931 PEH were approached. A total of 863 RT-PCR tests were performed at 14 testing events, and 334 antibody tests were performed at 5 testing events. Overall, 604 and 259 RT-PCR tests were conducted in 4 shelters and 3 encampments, respectively; 189 and 145 antibody tests were conducted in 3 shelters and 2 encampments, respectively. PEH tested in shelters were older, more often men, less often Native American, and less likely to report COVID-19 symptoms than those tested at encampments (Table 1). Overall, 9% of PEH tested in shelters tested positive for SARS-CoV-2 compared to 3% of PEH tested in encampments (p=0.002); 8% of men had positive RT-PCR results compared to 2% of women (p=0.03) (Table 2). PEH tested at shelters had a higher percentage of detectable SARS-CoV-2 antibodies than those tested in encampments (24% vs 8%, p=0.0002; Table 3). Neither RT-PCR nor antibody test results differed significantly by race or ethnicity. Table 1. Demographics of participants residing in encampments compared with shelters in Denver, Colorado, May-July 2020 (n=931) Table 2. Comparison of participants testing positive or negative for SARS-CoV-2 RT-PCR* by location and demographics, in Denver, Colorado, May-July 2020 Table 3. Comparison of participants testing positive or negative for antibodies against SARS-CoV-2 by location and demographics in Denver, Colorado, May-July 2020 Conclusion A greater percentage of PEH tested positive for both SARS-CoV-2 RNA and antibodies at shelters than encampments, suggesting that continued assessment of mitigation strategies in shelters should be a priority. Disclosures All Authors: No reported disclosures


2020 ◽  
Vol 59 (1) ◽  
pp. e01892-20 ◽  
Author(s):  
Sarah E. Turbett ◽  
Melis Anahtar ◽  
Anand S. Dighe ◽  
Wilfredo Garcia Beltran ◽  
Tyler Miller ◽  
...  

ABSTRACTSensitive and specific severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic assays are needed to inform diagnostic, therapeutic, and public health decision-making. We evaluated three commercial serologic assays as stand-alone tests and as components of two-test algorithms. Two nucleocapsid antibody tests (Abbott IgG and Roche total antibody) and one spike protein antibody test (DiaSorin IgG) were included. We assessed sensitivity using 128 serum samples from symptomatic PCR-confirmed coronavirus disease 2019 (COVID-19)-infected patients and specificity using 1,204 samples submitted for routine serology prior to COVID-19’s emergence, plus 64 pandemic-era samples from SARS-CoV-2 PCR-negative patients with respiratory symptoms. Assays were evaluated as stand-alone tests and as components of a two-test algorithm in which positive results obtained using one assay were verified using a second assay. The two nucleocapsid antibody tests were more sensitive than the spike protein antibody test overall (70% and 70% versus 57%; P ≤ 0.003), with pronounced differences observed using samples collected 7 to 14 days after symptom onset. All three assays were comparably sensitive (≥89%; P ≥ 0.13) using samples collected >14 days after symptom onset. Specificity was higher using the nucleocapsid antibody tests (99.3% and 99.7%) than using the spike protein antibody test (97.8%; P ≤ 0.002). When any two assays were paired in a two-test algorithm, the specificity was 99.9% (P < 0.0001 to 0.25 compared with the individual assays), and the positive predictive value (PPV) improved substantially, with a minimal effect on the negative predictive value (NPV). In conclusion, two nucleocapsid antibody tests outperformed a spike protein antibody test. Pairing two different serologic tests in a two-test algorithm improves the PPV, compared with the individual assays alone, while maintaining the NPV.


2021 ◽  
Author(s):  
Anton Barchuk ◽  
Daniil Shirokov ◽  
Mariia Sergeeva ◽  
Rustam Tursun-zade ◽  
Olga Dudkina ◽  
...  

Background: An evident geographical variation in the SARS-CoV-2 spread requires seroprevalence studies based on local tests with robust validation against already available antibody tests and neutralization assays. This report summarizes the evaluation of antibody tests used in the representative population-based serological study of SARS-CoV-2 in Saint Petersburg, Russia. Methods: We used three different antibody tests throughout the study: chemiluminescent microparticle immunoassay (CMIA) Abbott Architect SARS-CoV-2 IgG, Enzyme-linked immunosorbent assay (ELISA) CoronaPass total antibodies test, and ELISA SARS-CoV-2-IgG-EIA-BEST. Clinical sensitivity was estimated with the SARS-CoV-2 PCR test as the gold standard and specificity in pre-pandemic sera samples using the cut-off recommended by manufacturers. Paired and unpaired serum sets were used. Measures of concordance were also calculated in the seroprevalence study sample against the microneutralization test (MNA). Findings: Sensitivity was equal to 91.1% (95% CI: 78.8-97.5) and 90% (95% CI: 76.4-96.4) for ELISA Coronapass and ELISA Vector-Best respectively. It was equal to 63.1% (95% CI (50.2-74.7) for CMIA Abbott. Specificity was equal to 100% for all the tests. Comparison of ROCs for three tests has shown lower AUC for CMIA Abbott, but not for ELISA Coronapass and CMIA Abbott. The cutoff SC/O ratio of 0.28 for CMIA-Abbott resulted in a sensitivity of 80% at the same full level of specificity. In less than one-third of the population-based study participants with positive antibody test results, we detected neutralizing antibodies in titers 1:80 and above. There was a moderate correlation between antibody assays results and MNA. Interpretation: Our validation study encourages the use of local antibody tests for population-based SARS-CoV-2 surveillance and sets the reference for the seroprevalence correction. Available tests are sensitive enough to detect antibodies in most individuals with previous positive PCR tests with a follow-up of more than 5 months. The Abbott Architect SARS-CoV-2 IgG's sensitivity can be significantly improved by incorporating a new cut-off. Relying on manufacturers' test characteristics for correction of reported prevalence estimates may introduce bias to the study results.


2021 ◽  
pp. 00080-2021
Author(s):  
Hani Abo-Leyah ◽  
Stephanie Gallant ◽  
Diane Cassidy ◽  
Yan Hui Giam ◽  
Justin Killick ◽  
...  

BackgroundHealthcare workers (HCW) are believed to be at increased risk of SARS-CoV-2 infection. It is not known to what extent the natural production of antibodies to SARS-CoV-2 is protective against re-infection.MethodsA prospective observational study of HCW's in Scotland (UK) from May to September 2020. The Siemens SARS-CoV-2 total antibody assay was used to establish seroprevalence in this cohort. Controls, matched for age and sex to the general local population, were studied for comparison. New infections (up to 2/12/2020) post antibody testing were recorded to determine if the presence of SARS-CoV-2 antibodies protect against re-infection.ResultsA total of 2063 health and social care workers were recruited for this study. At enrolment 300 HCW had a positive antibody test (14.5%). 11/231 control sera tested positive (4.8%). HCW therefore had an increased likelihood of a positive test (Odds ratio 3.4 95% CI 1.85–6.16, p<0.0001). Dentists were most likely to test positive. 97.3% of patients who had previously tested positive for SARS-CoV-2 by RT-PCR had positive antibodies. 18.7% had an asymptomatic infection. There were 38 new infections with SARS-CoV-2 in HCW who were previously antibody negative and one symptomatic RT-PCR positive re-infection. The presence of antibodies was therefore associated with an 85% reduced risk of re-infection with SARS-CoV-2 (HR 0.15, 95% CI 0.06 to 0.35, p=0.026).ConclusionHCW were three times more likely to test positive for SARS-CoV-2 than the general population. Almost all infected individuals developed an antibody response which was 85% effective in protecting against re-infection with SARS-CoV-2.


2020 ◽  
Vol 58 (11) ◽  
Author(s):  
Harry E. Prince ◽  
Tara S. Givens ◽  
Mary Lapé-Nixon ◽  
Nigel J. Clarke ◽  
Dale A. Schwab ◽  
...  

ABSTRACT A total of 1,200 serum samples that were tested for SARS-CoV-2 IgG antibody using the Abbott Architect immunoassay targeting the nucleocapsid protein were run in 3 SARS-CoV-2 IgG immunoassays targeting spike proteins (DiaSorin Liaison, Ortho Vitros, and Euroimmun). Consensus-positive and consensus-negative interpretations were defined as qualitative agreement in at least 3 of the 4 assays. Agreement of the 4 individual assays with a consensus-negative interpretation (n = 610) ranged from 96.7% to 100%, and agreement with a consensus-positive interpretation (n = 584) ranged from 94.3% to 100%. Laboratory-developed inhibition assays were utilized to evaluate 49 consensus-negative samples that were positive in only one assay; true-positive reactivity was confirmed in only 2 of these 49 (4%) samples. These findings demonstrate very high levels of agreement among 4 SARS-CoV-2 IgG assays authorized for emergency use, regardless of antigen target or assay format. Although false-positive reactivity was identified, its occurrence was rare (no more than 1.7% of samples for a given assay).


2008 ◽  
Vol 20 (6) ◽  
pp. 735-743 ◽  
Author(s):  
Ramon M. Molina ◽  
Wayne Chittick ◽  
Eric A. Nelson ◽  
Jane Christopher-Hennings ◽  
Raymond R. R. Rowland ◽  
...  

Three assays were evaluated for their ability to detect antibodies against Porcine reproductive and respiratory syndrome virus (PRRSV) in porcine muscle transudate (“meat juice”) samples. Samples were derived from 91 pigs inoculated with PRRSV isolate VR-2332 and 46 age-matched controls. Serum and muscle ( Musculus longissimus dorsi) samples were collected from randomly selected animals euthanized at ∼14-day intervals from 28 to 202 days postinoculation. Serum samples were assayed at a dilution of 1:40, and muscle transudate samples were assayed at 5 dilutions (1:2, 1:5, 1:10, 1:20, 1:40) using a commercial PRRSV antibody enzyme-linked immunosorbent assay (ELISA). In addition, muscle transudate samples were tested using an indirect fluorescent antibody test (IFAT) at 5 dilutions (1:2, 1:5, 1:10, 1:20, 1:40). Attempts to assay muscle transudate samples for neutralizing antibodies using a modified fluorescent focus neutralization assay were unsuccessful. Receiver operator characteristic (ROC) curve analyses were used to estimate cutoff thresholds and the associated diagnostic sensitivities and specificities for ELISA and IFAT at each dilution. For ELISA, muscle transudate samples at the ROC-optimized cutoffs were >95% sensitive and 100% specific at each dilution. At a cutoff dilution of ≥1:5, the IFAT diagnostic sensitivity and specificity of muscle transudate was estimated at 63.3% and 100%, respectively. These findings validated the use of muscle transudate samples in PRRSV surveillance programs based on ELISA antibody testing.


2020 ◽  
Vol 55 (1) ◽  
pp. 62-66 ◽  
Author(s):  
Tim Meyer ◽  
Dietrich Mack ◽  
Katrin Donde ◽  
Oliver Harzer ◽  
Werner Krutsch ◽  
...  

ObjectivesTo evaluate the restart of the German Bundesliga (football (soccer)) during the COVID-19 pandemic from a medical perspective.MethodsParticipants were male professional football players from the two highest German leagues and the officials working closely with them. Our report covers nine match days spread over 9 weeks (May to July 2020). Daily symptom monitoring, PCR testing for SARS-CoV-2 RNA twice weekly, and antibody tests (on two occasions—early during the phase in May 2020 and in the week of the last match) were conducted. Target variables were: (1) onset of typical COVID-19 symptoms, (2) positive PCR results, and (3) IgG seroconversion against SARS-CoV-2. All detected seroconversions were controlled by neutralisation tests.FindingsSuspicious symptoms were reported for one player; an immediate additional PCR test as well as all subsequent diagnostic and antibody tests proved negative for coronavirus. Of 1702 regularly tested individuals (1079 players, 623 officials members), 8 players and 4 officials tested positive during one of the first rounds of PCR testing prior to the onset of team training, 2 players during the third round. No further positive results occurred during the remainder of the season. 694 players and 291 officials provided two serum samples for antibody testing. Nine players converted from negative/borderline to positive (without symptoms); two players who initially tested positive tested negative at the end of the season. 22 players remained seropositive throughout the season. None of the seroconversions was confirmed in the neutralisation test.ConclusionProfessional football training and matches can be carried out safely during the COVID-19 pandemic. This requires strict hygiene measures including regular PCR testing.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S434-S435
Author(s):  
Eun Ju Choo ◽  
Se Yoon Park

Abstract Background The measles, mumps, and rubella (MMR) vaccination to children was accelerated in South Korea as the National Immunization Programs in 1985. A two-dose MMR vaccination schedule was introduced in 1997. However, outbreaks of measles in healthcare institution continued to occur. Recent studies revealed that the seroprevalence of measles in healthcare workers (HCWs) was approximately 40–60% in twentieth. The purpose of this study was to determine the seroprevalence of MMR antibodies in HCWs to establish strategy for vaccination. Methods To prevent nosocomial transmission of measles, test for MMR antibody of HCWs was conducted in three teaching hospitals from January to February in 2019. The testing was conducted only in the patient contact departments. We excluded HCWs who did a history of vaccination after starting their work. Anti-measles IgG and anti-mumps IgG was detected using chemiluminescence immunoassay. Anti-rubella IgG was detected using chemiluninescence microparticle immunoassay. Equivocal value was treated as negative. We also compare the costs between strategies two-dose vaccination without antibody tests and vaccination after antibody testing. Results Total 598 HCWs were included in analysis. Of the HCWs tests, 92.6% were seropositive to measles, 86.6% to mumps, and 79.7% to rubella. In the linear regression analysis, the seropositive of measles and rubella antibodies was increased in proportion to age (β-coefficient 43.4, 95% CI 35.1–51.6, P < 0.001 and β-coefficient 10.2, 95% CI 7.2–13.2, respectively). But, the seropositive to mumps was not related to age (β-coefficient 2.6, 95% CI -5.4–10.7, P = 0.52). The HCWs who has seropositive to all MMR was 67.2%. It was highest in 1970th birthyear (77.1%) and lowest in 1980th birthyear (60.6%). It costs less 18,000 wons ($15.5) per HCWs in strategy of vaccination after antibody testing than two-dose vaccination without antibody testing. Conclusion Our data warrant the needs for routine antibody test for MMR, followed by MMR vaccination in Korean HCWS. We expect that this strategy can save costs and avoid unnecessary vaccination. Disclosures All authors: No reported disclosures.


2020 ◽  
Vol 6 (Khusus) ◽  
pp. 47
Author(s):  
Anita Suswanti Agustina ◽  
Rizana Fajrunni'mah

COVID-19 is caused by SARS-CoV-2, which can spread rapidly from human to human. There are several laboratory tests to detect COVID-19, including the Reverse Transcription-Polymerase Chain Reaction (RT-PCR) method and a rapid test antibody test to detect antibody reactions to SARS-CoV-2. Both methods have advantages and disadvantages of each, while the literature study comparing the two methods is currently limited. The type of research used is library research. Research materials have been collected from various journals, books, and guidelines, in line with the research topic, to obtain 24 library sources. The results of the literature study indicate that the target genes that can be used to detect COVID-19 RT-PCR methods include the N, E, RdRp, and ORF1a/b genes. The sensitivity of rapid antibody tests is known to range from 68−89%, while the specificity of rapid antibody tests ranges from 91−100%. RT-PCR has the advantage of being able to detect low-concentration antigens, but RT-PCR has weaknesses such as requiring expensive equipment and inspection fees, specially trained laboratory personnel, long working time, and high risk of exposure. Rapid antibody testing has advantages, including ease of sampling, lower testing costs, reduced risk of exposure to officers, does not require special equipment and space, but has the potential for cross-reactivity with other coronaviruses. Both the RT-PCR method and the rapid antibody test have their advantages and disadvantages, but rapid antibody testing with RT-PCR can improve the diagnosis of COVID-19. The results of this literature study are expected to be continued as a basis for further research on RT-PCR examination and antibody rapid test for COVID-19 detection in Indonesia, accompanied by information on onset time and time-testing with a large sample of research.


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