Antibody Response to inactive SARS-CoV-2 vaccination in a cohort of elderly patients living with obesity.

Introduction Obesity and aging negatively affect the immune system and host defense mechanisms, increasing vulnerability to, worsening prognosis of infectious diseases and leading to vaccine failure. Our aim is to investigate the antibody response against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) spike antigens, and the risk factors affecting antibody levels in elderly people living with obesity (PwO) after inactive SARS-CoV-2 vaccine (CoronaVac) administration. Methods One hundred twenty-three consecutive elderly patients with obesity (age>65 years, Body Mass Index (BMI)>30kg/m2) and 47 adults with obesity (age 18-64 years, BMI>30kg/m2) admitted between August and November 2021 were enrolled. Seventy five non-obese elderly people (age >65 years, BMI 18.5-29.9 kg/m2) and 105 non-obese adults (age 18-64 years, BMI 18.5-29.9 kg/m2) were recruited from subjects who visited Vaccination Unit. SARS-CoV-2 spike-protein antibody titers were measured in patients with obesity and non-obese controls who received two doses of CoronaVac. Results SARS-CoV-2 levels of patients with obesity were found to be significantly lower than those of non-obese elderly individuals who had non-prior infection.There was no difference in SARS-CoV-2 levels between patients with obesity and non-obese individuals with prior infection. Age and SARS-CoV-2 level were found to be highly correlated in the correlation analysis in the group of elderly individuals (r:-0.184). In multivariate regression analysis, when SARS-CoV-2 IgG was regressed on age, sex, BMI, Type 2 Diabetes Mellitus (T2DM) and Hypertension (HT), HT was found to be an independant factor on SARS-CoV-2 level (ß:-2730). Conclusion In non-prior infection group, elderly patients with obesity generated significantly reduced antibody titers against SARS-CoV-2 spike antigen after CoronaVac vaccine compared to non-obese people. It is anticipated that the results obtained will provide invaluable information about SARS-CoV-2 vaccination strategies in this vulnerable population. Antibody titers may be measured and booster doses should be delivered accordingly in elderly PwO for optimal protection.

Evaluation of the Diagnostic Performance of a SARS-CoV-2 and Influenza A/B Combo Rapid Antigen Test in Respiratory Samples

This study aimed to evaluate the performance characteristics of a rapid antigen test developed to detect SARS-CoV-2 (COVID-19), influenza A virus (IAV), and influenza B virus (IBV) (flu) compared with those of the real-time reverse transcription-polymerase chain reaction (rRT-PCR) method. One hundred SARS-CoV-2, one hundred IAV, and twenty-four IBV patients whose diagnoses were confirmed by clinical and laboratory methods were included in the patient group. Seventy-six patients, who were negative for all respiratory tract viruses, were included as the control group. The Panbio™ COVID-19/Flu A&B Rapid Panel test kit was used in the assays. The sensitivity values of the kit were 97.5%, 97.9%, and 33.33% for SARS-CoV-2, IAV, and IBV, respectively, in samples with a viral load below 20 Ct values. The sensitivity values of the kit were 16.7%, 36.5%, and 11.11% for SARS-CoV-2, IAV, and IBV, respectively, in samples with a viral load above 20 Ct. The kit's specificity was 100%. In conclusion, this kit demonstrated high sensitivity to SARS-CoV-2 and IAV for viral loads below 20 Ct values, but the sensitivity values were not compatible with PCR positivity for lower viral loads over 20 Ct values. Rapid antigen tests may be preferred as a routine screening tool in communal environments, especially in symptomatic individuals, when diagnosing SARS-CoV-2, IAV, and IBV with high caution.

Evaluation of the Diagnostic Performance of a SARS-CoV-2 and Influenza A/B Combo Rapid Antigen Test in Respiratory Samples.

This study aimed to evaluate the performance characteristics of a rapid antigen test developed to detect SARS-CoV-2 (COVID-19), influenza A virus (IAV), and influenza B virus (IBV) (flu) compared with those of the real-time reverse transcription-polymerase chain reaction (rRT-PCR) method. One hundred SARS-CoV-2, one hundred IAV, and twenty-four IBV patients whose diagnoses were confirmed by clinical and laboratory methods were included in the patient group. Seventy-six patients, who were negative for all respiratory tract viruses, were included as the control group. The Panbio™ COVID-19/Flu A&B Rapid Panel test kit was used in the assays. The sensitivity values of the kit were 97.5%, 97.9%, and 33.33% for SARS-CoV-2, IAV, and IBV, respectively, in samples with a viral load below 20 Ct values. The sensitivity values of the kit were 16.7%, 36.5%, and 11.11% for SARS-CoV-2, IAV, and IBV, respectively, in samples with a viral load above 20 Ct. The kit's specificity was 100%. In conclusion, this kit demonstrated high sensitivity to SARS-CoV-2 and IAV for viral loads below 20 Ct values, but the sensitivity values were not compatible with PCR positivity for lower viral loads over 20 Ct values. Rapid antigen tests may be preferred as a routine screening tool in communal environments, especially in symptomatic individuals, when diagnosing SARS-CoV-2, IAV, and IBV with high caution.

[Evaluation of the Diagnostic Performance of SARS-CoV-2 Rapid Antigen Tests in COVID-19 Patients]. / SARS-CoV-2 Hizli Antijen Testlerinin COVID-19 Hastalarindaki Tanisal Performanslarinin Degerlendirilmesi.

The gold standard in the definitive diagnosis of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is nucleic acid amplification tests (NAAT) due to their high sensitivity and specificity in detecting viral ribonucleic acid. However, while leaving two years behind in the pandemic, resources have come to the point of exhaustion in terms of both the economy and the manpower working in the field of health services. Therefore, the need for rapid, simple and accurate tests to diagnose SARS-CoV-2 infection continues. In this study, it was aimed to compare the performance characteristics of SARS-CoV-2 rapid antigen tests (RAgT) in the diagnosis of coronavirus disease 2019 (COVID-19) cases with the real-time reverse transcription-polymerase chain reaction (rRT-PCR) method. In Istanbul University-Cerrahpasa Faculty of Medicine COVID-19 Molecular Diagnosis Laboratory, SARS-CoV-2 RNA positive respiratory tract samples with viral loads of <25 Ct (cycle of treshold), 25-29 Ct, 30-35 Ct and 35

Heterologous booster COVID-19 vaccination elicited potent immune responses in HCWs.

The objective of our study was to evaluate the antibody responses of health care workers (HCWs) who were vaccinated with booster dose BNT162b2 6 months after 2 doses of the CoronoVac vaccine. The study included 318 HCWs vaccinated with inactive CoronaVac SARS-CoV-2 vaccine in 2 doses. Anti-spike/RBD IgG levels were measured immediately before and 1 month after the booster dose. In the sixth month after CoronaVac vaccination, the median of antibody levels of 1212.02 AU/ML, while it was 9283 AU/mL after BNT162b2 vaccination. IgG antibody titers of over 1050 AU/mL (which is equivalent to 1:80 dilution in the plaque reduction neutralization test) were detected in HCWs 15.09% and 97.8%, respectively. Our results showed that antibody titers increased 8-fold after the booster dose. We believe that the administration of the mRNA vaccine as a booster dose can provide more effective protection against COVID-19 infection, especially in individuals with risk factors.

BNT162b2 COVID-19 vaccination elicited protective robust immune responses in pediatric patients with inborn errors of metabolism.

Introduction: SARS-CoV-2 infection can lead to a life-threatening acute metabolic decompensation in children with inborn errors of metabolism (IEM), so vaccination is mandatory. However, IEMs can also impair innate or adaptive immunity, and the impact of these immune system alterations on immunogenicity and vaccine efficacy is still unknown. Here, we investigated humoral immune responses to the BNT162b2 mRNA COVID-19 vaccine and clinical outcomes in pediatric IEM patients. Methods: Fifteen patients between 12-18 years of age with a confirmed diagnosis of IEM, and received BNT162b2 were enrolled to the study. Patients with an anti-SARS-CoV-2 IgG concentration >50 AU/mL before vaccination were defined as "COVID-19 recovered" whereas patients with undetectable anti-SARS-CoV-2 IgG concentration were defined as "COVID-19 naïve". Anti-SARS-CoV-2 Immunoglobulin G (IgG) and SARS-CoV-2 neutralizing antibody (nAb) titers were measured to assess humoral immune response. Results: Anti-SARS-CoV-2 IgG titers and nAb IH% increased significantly after the first dose. The increase in antibody titers after first and second vaccination remained significant in COVID-19 naïve patients. Complete anti-SARS-CoV-2 IgG seropositivity and nAb IH% positivity was observed in all patients after the second dose. Vaccination appears to be clinically effective in IEM patients, as none of the patients had COVID-19 infection within six months of the last vaccination. Discussion: Humoral immune response after two doses of BNT162b2 in pediatric IEM patients was adequate and the immune response was not different from that of healthy individuals.

Waning immunity to inactive SARS-CoV-2 vaccine in healthcare workers: booster required.

AIMS: Despite high vaccination rates, increasing case numbers continue to be reported with the identification of new variants of concern, and the issue of durability of the vaccine-induced immune response remains hot topic. Real-life data regarding time-dependent immunogenicity of inactivated COVID-19 vaccines are scarce. We aimed to investigate the changes in the antibody at the different times after the second dose of the CoronaVac vaccine. METHODS: The study included 175 HCWs vaccinated with inactive CoronaVac (Sinovac Life Sciences, China) SARS-CoV-2 vaccine in two doses. Anti-spike/RBD IgG levels were measured first, third, and sixth months after the second dose. Chemiluminescent microparticle immunoassay (IgG II Quant test, Abbott, USA), which is 100% compatible with plaque reduction neutralization test, was used. RESULTS: Mean age of the participants was 38 ± 11.23 years (range between 22 and 66) of whom 119 (63.9%) were female, and 56 (32%) were male. Dramatic reductions were demonstrated in median antibody levels particularly in the infection-naïve group, comprising 138 HCWs compared to those with prior history of COVID-19 infection (n = 37) (p < 0.001). There was no difference between the two groups in terms of age, gender, blood groups, BMI, and comorbid diseases. CONCLUSIONS: While antibody positivity remained above 90% in the 6th month after two doses of inactivated vaccine in HCWs, the median titers of neutralizing antibodies decreased rapidly. The decrease was more rapid and significant in those with no history of prior COVID-19 infection. In this critical phase of the pandemic, where we are facing the dominance of the Omicron variant after Delta, booster doses have become vital.

Development of in House ELISAs to Detect Antibodies to SARS-CoV-2 in Infected and Vaccinated Humans by Using Recombinant S, S1 and RBD Proteins.

(1) Background: The aim of this study was to produce in-house ELISAs which can be used to determine SARS-CoV-2-specific antibody levels directed against the spike protein (S), the S1 subunit of S and the receptor binding domain (RBD) of S in SARS-CoV-2 vaccinated and infected humans. (2) Methods: Three in-house ELISAs were developed by using recombinant proteins of SARS-CoV-2, namely the S, S1 and RBD proteins. Specificity and sensitivity evaluations of these tests were performed using sera from SARS-CoV-2-infected (n = 70) and SARS-CoV-2-vaccinated (n = 222; CoronaVac vaccine) humans in Istanbul, Turkey. The analyses for the presence of SARS-CoV-2-specific antibodies were performed using the in-house ELISAs, a commercial ELISA (Abbott) and a commercial surrogate virus neutralization test (sVNT). We also analyzed archival human sera (n = 50) collected before the emergence of COVID-19 cases in Turkey. (3) Results: The sensitivity of the in-house S, S1 and RBD ELISAs was found to be 88.44, 90.17 and 95.38%, while the specificity was 72.27, 89.08 and 89.92%, respectively, when compared to the commercial SARS-CoV-2 antibody test kit. The area under curve (AUC) values were 0.777 for the in-house S ELISA, 0.926 for the S1 ELISA, and 0.959 for the RBD ELISA. The kappa values were 0.62, 0.79 and 0.86 for the S, S1 and RBD ELISAs, respectively. (4) Conclusions: The in-house S1 and RBD ELISAs developed in this study have acceptable performance characteristics in terms of sensitivity, specificity, AUC and kappa values. In particular, the RBD ELISA seems viable to determine SARS-CoV-2-specific antibody levels, both in infected and vaccinated people, and help mitigate SARS-CoV-2 outbreaks and spread.

Comparison of SARS-CoV-2 Antibody Levels after a Third Heterologous and Homologous BNT162b2 Booster Dose.

This study aimed to determine the anti-S (receptor binding protein) RBD IgG antibody titers formed against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) and the neutralizing antibody inhibition percentages (nAb IH%) in blood samples taken after two doses of inactive or mRNA-based vaccine and a booster dose. Volunteers with two doses of inactivated CoronaVac (heterologous group; n = 75) and BioNTech (BNT)162b2 mRNA vaccine (homologous group; n = 75) were included in this study. All participants preferred the BNT162b2 vaccine as a booster dose. First, peripheral blood samples were taken 3 months after the second vaccine dose. Second, peripheral blood samples were taken 1 month after the booster dose. Anti-S-RBD IgG titers were determined by CMIA (SARS-CoV-2 IgG II Quant). Neutralizing antibodies were detected by a surrogate neutralization assay (SARS-CoV-2 NeutraLISA, Euroimmun, Lübeck, Germany). The median age of the volunteers was 40 (IQR 29-47) years old. After the heterologous booster dose, anti-S-RBD IgG levels and neutralizing antibodies increased approximately 50-fold and 9-fold, respectively. Anti-S-RBD IgG titers increased by 9 and 57 times, respectively, while nAb IH% increased by 1.5 and 16 times, respectively, among those with heterologous reminder doses and those with and without a prior history of coronavirus disease (COVID-19). This study showed that after the administration of a heterologous booster dose with BNT162b2 to those whose primary vaccination was with inactivated CoronaVac, the binding and neutralizing antibody levels were similar to those who received a homologous BNT162b2 booster dose. It was observed that the administration of heterologous and homologous booster doses resulted in the development of similar levels of neutralizing antibodies, independently from a prior history of COVID-19.

Risk Factors Influencing Seroconversion after Inactive SARS-CoV-2 Vaccination in People Living with Obesity.

INTRODUCTION: The aim of this study was to investigate the antibody titers against SARS-CoV-2 spike antigens and the risk factors affecting antibody levels in people living with obesity (PwO) after inactive SARS-CoV-2 vaccine (CoronaVac) administration. METHODS: 169 consecutive patients with obesity who visited the Center for Obesity Management at Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty Hospitals, between May and August 2021, were invited to the study. The nonobese control group was recruited from 191 subjects who visited the Cerrahpasa Hospitals Vaccination Unit. The study group and the nonobese control group have already received two doses of inactive SARS-CoV-2 vaccine. The SARS-CoV-2 IgG nucleocapsid antibody test was administered to patients and control subjects to discover those who had prior SARS-CoV-2 infection. Forty-one patients who had prior infection and received two doses of vaccine were also included in the study as a subgroup. Blood samples were taken on the 3rd to 4th week after the second vaccination. SARS-CoV-2 IgG antibody titers were determined by quantitative serological methods. RESULTS: Antibody titers against SARS-CoV-2 spike antigen of individuals with BMI ≥30.0 kg/m2 were significantly lower than those with BMI <30 kg/m2 (p = 0.001) in the study group. Moreover, the antibody titers in people with BMI ≥30.0 kg/m2 were significantly lower than in those having a BMI <30.0 kg/m2 in the subgroup (p = 0.03). Age (p = 0.03), BMI (p = 0.006), and hypertension (p = 0.03) were found to be independent risk factors for antibody response in PwO. Women with non-prior SARS-CoV-2 infection showed a significantly higher antibody response then men (p = 0.001). CONCLUSION: SARS-CoV-2-Immunoglobulin G antibody levels against inactive (CoronaVac) vaccine were found to be lower in PwO compared to nonobese individuals. Antibody titers may be measured, and booster doses should be delivered accordingly in PwO for optimal protection.

Antibody Response to SARS-CoV-2 Vaccines in People with Severe Obesity.

AIM: Obesity is a disease complicating the course of COVID-19 and SARS-CoV-2 vaccine effectiveness in adults with obesity may be compromised. Our aim is to investigate the spike-protein receptor-binding domain antibody titers against BNT162b2 mRNA and inactivated SARS-CoV-2 (CoronaVac) vaccines in people with severe obesity. It is anticipated that the results to be obtained may provide invaluable information about future SARS-CoV-2 vaccination strategies in this vulnerable population. METHODS: A total of 124 consecutive patients with severe obesity (age > 18 years, BMI ≥ 40 kg/m2) presenting between August and November 2021 were enrolled. The normal weight control group (age > 18, BMI 18.5-24.9 kg/m2) was recruited from 166 subjects who visited the vaccination unit. SARS-CoV-2 spike-protein antibody titers were measured in patients with severe obesity and in normal weight controls who received two doses of BNT162b2, or CoronaVac vaccines. SARS-CoV-2 IgG Nucleocapsid Protein antibody (NCP Ab) testing was performed to discover prior SARS-CoV-2 infection. Blood samples were taken from individuals at 4th week and after 2nd dose of vaccination. SARS-CoV-2 IgG antibody titers were determined by quantitative serological methods. RESULTS: A total of 290 individuals (220 female, 70 male) who have received two doses of BNT162b2 or CoronaVac vaccines were enrolled in the study. Seventy had prior SARS-CoV-2 infection. In 220 subjects (non-prior infection) vaccinated with BNT162b2 or CoronaVac, the antibody titers against SARS-CoV-2 spike antigen of patients with severe obesity were significantly lower than normal weight controls (p = 0.001, p = 0.001 respectively). In seventy subjects with prior SARS-CoV-2 infection, spike antigen antibody titers in patients with severe obesity, vaccinated with BNT162b2 or CoronaVac, were not significantly different from normal weight controls (p = 0.1, p = 0.1 respectively). In patients with severe obesity, with and without prior SARS-CoV-2 infection, spike antigen antibody levels of those vaccinated with BNT162b2 were found to be significantly higher than those vaccinated with CoronaVac (p = 0.043, p < 0.001 respectively). CONCLUSION: Patients with severe obesity generated significantly reduced antibody titers against SARS-CoV-2 spike antigen after CoronaVac and BNT162b2 vaccines compared to people with normal weight. Antibody levels in patients with severe obesity vaccinated with BNT162b2 were found to be significantly higher than those vaccinated with CoronaVac. People living with severe obesity should be prioritized for COVID-19 vaccination and BNT162b2 vaccine may be recommended for this vulnerable population.

Waning of SARS-CoV-2 Vaccine-Induced Immune Response over 6 Months in Peritoneal Dialysis Patients and the Role of a Booster Dose in Maintaining Seropositivity.

INTRODUCTION: Although lower than general population, newly developed SARS-CoV-2 vaccines generate immune responses in end-stage kidney disease patients. However, the persistence of immune responses in the long term is not known yet. This study aimed to evaluate humoral immune responses in peritoneal dialysis (PD) patients over 6 months and to analyze the effects of the booster dose. METHODS: Humoral immune responses of PD patients were measured after initial SARS-CoV-2 vaccinations and after 6 months following initial vaccinations. Immune responses were compared between patients who received and did not receive booster doses. PD patients were compared with 41 hemodialysis (HD) patients and 61 healthy controls. Humoral immune responses were measured by a commercial test that detects antibodies toward the receptor-binding domain of the spike protein of SARS-CoV-2. RESULTS: Twenty PD patients were evaluated over 6 months. The initial seropositivity rate was 90.9% with inactivated vaccine and 100% with mRNA vaccine. Seropositivity decreased to 44.4% after 6 months, and a booster dose helped in maintaining the 100% of seropositivity (p = 0.005). Magnitude of humoral response at the 6th month was also higher in patients who received the third dose (1,132.8 ± 769.6 AU/mL vs. 400.0 ± 294.6 AU/mL; p = 0.015). Among patients who did not receive the third dose, those who got mRNA vaccine could maintain higher seropositivity than others who got inactivated vaccine (75% vs. 40% for PD, 81.8% vs. 50% for HD). Seropositivity and antibody levels were similar for PD and HD patients after 6 months (p = 0.24 and 0.56) but lower than healthy controls (p = 0.0013). CONCLUSION: SARS-CoV-2 vaccine-induced antibody levels and seropositivity of PD patients significantly fall after 6 months. A booster dose after around 3 months following initial immunization might help in maintaining seropositivity.

Anti-SARS-CoV-2 IgG and Neutralizing Antibody Levels in Patients with Past COVID-19 Infection: A Longitudinal Study

Background: Monitoring the longevity of immunoglobulin G (IgG) responses following severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infections is vital to understanding the role of antibodies in preventing infection. Aims: To determine the quantitative IgG responses specific to the Spike-S1 (S1) receptor-binding domain (S1/RBD) region of the virus in serum samples taken between 4 weeks and 7 months after polymerase chain reaction (PCR) positivity in patients who are diagnosed with coronavirus disease-2019 (COVID-19). Study Design: A longitudinal study. Methods: This study included 113 patients with a clinical and molecular diagnosis of COVID-19. The first and second serum samples were taken 1 and 7 months, respectively, after the PCR positivity. S1/RBD-specific IgG antibody response was assayed using anti-SARS-CoV- 2 QuantiVac ELISA (IgG) kit (Euroimmun, Lübeck, Germany). The neutralizing antibodies were investigated in 57 patients whose IgG test results were above the cut-off value. Results: In 57 patients with SARS-CoV-2 IgG, the anti-SARS-CoV-2 IgG quantitative antibody levels significantly decreased after 7 months (Z = −2.197, p = 0.028). A correlation was detected between the anti-SARS-CoV-2 IgG and nAb percent inhibition (IH%) levels detected in 1 month (rs = 0.496, p < 0.001), but without significant correlation in serum samples taken on 7 months. The nAb IH% levels of the first and second were compared for COVID-19 severity and revealed no statistical difference (p = 0.256). In the second serum sample, the nAb IH%s of patients with moderate COVID-19 showed a statistically significant difference from patients with mild COVID-19 (p = 0.018), but without significant differences between severe and moderate or mild COVID-19. Conclusion: SARS-CoV-2 quantitative IgG antibody titers are significantly reduced at long-term follow-up (> 6 months). Due to the limited information on seroconversion, comprehensive studies should be conducted for long-term follow-up of the immune response against SARS-CoV-2.

Inactive SARS-CoV-2 vaccine generates high antibody responses in healthcare workers with and without prior infection.

BACKGROUND AND OBJECTIVES: Healthcare workers (HCWs) were among the first groups to be vaccinated in Turkey. The data to be obtained by the vaccination of HCWs would guide wide spread vaccination programs. MATERIALS AND METHODS: The study included 330 HCWs working at Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty Hospital and vaccinated with inactive CoronaVac (Sinovac Life Sciences, China) SARS-CoV-2 vaccine in two doses (28 days apart). Anti-Spike /RBD IgG levels were measured 14 days after the first dose and 28 days after the second dose. Chemiluminescent microparticle immunoassay (CMIA) (ARCHITECT IgG II Quant test, Abbott, USA), which is 100% compatible with plaque reduction neutralization test (PRNT), was used. RESULTS: Of the participants, 211 (63.9%) were female, 119 (36.1%) were male, and mean age was 39.6 ± 7.7 years. In those without prior COVID-19 history; (n = 255) antibody positivity was detected as 48.2% (95% CI: 42.1-54.3) 14 days after the first dose of vaccine, and 99.2% (95% CI: 98.1-100) at day 28 after the second dose. Antibody titers were significantly lower in patients with hypertension (p = 0.011). In those with prior history of COVID-19 (n = 75); both the antibody positivity rates after the first vaccine (48.2% vs 100%, p = 0.000) and the anti-spike/RBD antibody levels after the second vaccine (with a ≥ 1050 AU/mL titer equivalent to PRNT 1/80 dilution) was significant than infection-naive group (25.9% vs. 54.7%, p = 0.000). Antibody positivity after two doses of vaccination for all study group was 99.4% (95% CI: 98.6-100). CONCLUSIONS: Two doses CoronaVac produce effective humoral immunity in HCWs. Antibody response is significantly higher in those with prior history of COVID-19 than infection-naive group. Given no significant benefit of the second dose, a single shot of vaccination may be sufficient for those with prior history of COVID-19. Monitoring humoral and cellular immune responses, considering new variants, is required to validate this approach.

[Evaluation of the Diagnostic Performance of Different Principles of SARS-CoV-2 Commercial Antibody Tests in COVID-19 Patients]. / SARS-CoV-2 ile Ilgili Farkli Prensipli Ticari Antikor Testlerinin COVID-19 Hastalarindaki Tanisal Performanslarinin Degerlendirilmesi.

Following the emergence of severe acute respiratory syndrome coronavirus-2 (SARS CoV-2) and using only PCR for diagnosis, antibody tests have been rapidly developed by various commercial companies. There are differences between the sensitivity and specificity of these tests due to the usage of different viral target proteins and antibody subclasses. In order to evaluate the diagnostic use of these tests, we aimed to examine the diagnostic performance, especially sensitivity and specificity, of SARS-CoV-2 IgM, IgA and IgG tests of various companies (Abbott, Roche, Euroimmun, Dia.Pro, Anshlabs, Vircell, UnScience and RedCell), which have different principles (ECLIA/CLIA, EIA, LFA). Current (n= 180) and past (n= 180) COVID-19 patients with clinical and molecular diagnosis of COVID-19 admitted to Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine Hospital, Pandemic Polyclinic with suspected COVID-19 infection, were included in our study. The patients admitted within the first 3 weeks after the onset of symptoms were included in the current patient group, and those admitted at the third and after the third week were included in the past patient group. Serum samples (n= 180) obtained from Istanbul Sisli Hamidiye Etfal Training and Research Hospital, Blood Center between April and June 2018 before the COVID-19 pandemic were included in the study as a control group. All the tests included in our study were studied with the recommendations of the manufacturer companies. Between the IgG detection tests with different principles in patients with past COVID-19, the sensitivity and specificity values of the most effective tests were; 86.7%/99.4% (Abbott), 86.1%/98.9% (Dia.Pro), 91.3%/95% (RedCell). Between the IgM detection tests with different principles in current COVID-19 patients, the sensitivity and specificity values were; 67.8%/99.4% (Abbott), 68.9%/98.6% (Vircell), 50%/97.5% (RedCell). Abbott IgM with a kappa coefficient of 0.67 and Vircell IgM + IgA test with a kappa coefficient of 0.65 showed the best fit in patients with current COVID-19 infection. In patients with past COVID-19, Abbott IgG with 0.86 kappa coefficient and Dia.Pro IgG test with 0.85 kappa coefficient showed the best match. Due to the low sensitivity of IgM detection antibody tests, they should not be preferred instead of real-time reverse transcriptase polymerase chain reaction in routine diagnosis. IgG detection tests may be preferred to detect the antibody response and the titers in people who have had COVID-19 for population seroprevalence and especially therapeutic immune plasma production. However, it is thought that the combined use of both ECLIA/CLIA-based and EIA/ELISA-based tests together may be more effective in routine use for SARS-CoV-2 IgG tests.