scholarly journals Evaluation of Performance of Detection of IgG and IgM Antibody Against Spike Protein of SARS-CoV-2 by a Rapid Kit in a Real-Life Hospital Setting

2021 ◽  
Author(s):  
Monica Irungbam ◽  
Anubhuti Chitkara ◽  
Vijay Kumar Singh ◽  
Subash Chandra Sonkar ◽  
Abhisekh Dubey ◽  
...  
Keyword(s):  
Real Life ◽  
Hospital Setting ◽  
Antibody Test ◽  
Protein S ◽  
Spike Protein ◽  
Diagnostic Efficiency ◽  
Rt Pcr ◽  
Antibody Testing ◽  
Diagnostic Efficacy ◽  
Rapid Antibody

Abstract Background Antibody testing are often used for serosurveillance of COVID-19. ELISA and Chemiluminesence based antibody test are quiet sensitive and specific for such serological testing. Rapid antibody tests are developed and effectively used for this purpose. But their diagnostic efficiency needs to be evaluated. So, the present study was conducted in a dedicated COVID-19 hospital in Delhi, India to evaluate the diagnostic efficacy of a Rapid antibody kit for COVID-19. Material and Method : Sixty COVID-19 confirmed cases by RT-PCR were recruited and categorized as early, intermediate and late cases based on the number of days of their first RT-PCR + ve tests, 20 subjects in each category. Twenty samples from pre-covid era were taken as controls. IgM and IgG antibodies against RBD of spike protein (S) of SARS-CoV2 virus were detected by Rapid antibody test and compared with total antibody against the nucleocapsid (N) antigen of SARS-CoV-2 by Electrochemiluminescence based Immunoassay (ECLIA). Results The detection IgM against Receptor binding domain (RBD) of spike protein by rapid kit was 0-37.5% sensitive and 0-100% specific for diagnosis of SARS-CoV-2 infection. However, efficacy of detection of IgG by rapid kit was 87–89% sensitive and 75–100% specific when compared with total antibody against N antigen measured by ECLIA based immunoassay. Conclusion It can be concluded that detection of IgM against RBD of S protein by rapid kit is not effective but IgG detection can be used as an effective diagnostic tool for SARS-COV-2 infection.

scholarly journals Perbandingan Metode RT-PCR dan Tes Rapid Antibodi untuk Deteksi COVID-19

2020 ◽  
Vol 6 (Khusus) ◽  
pp. 47
Author(s):  
Anita Suswanti Agustina ◽  
Rizana Fajrunni'mah
Keyword(s):  
Rapid Test ◽  
Antibody Test ◽  
Rt Pcr ◽  
Literature Study ◽  
Antibody Testing ◽  
Advantages And Disadvantages ◽  
Pcr Method ◽  
Risk Of Exposure ◽  
Antibody Tests ◽  
Rapid Antibody

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.

scholarly journals Efficacy of Fluorecare SARS-CoV-2 Spike Protein Test Kit for SARS-CoV-2 detection in nasopharyngeal samples of 121 individuals working in a manufacturing company

PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0262174
Author(s):  
Valentina Tonelotto ◽  
Annamaria Davini ◽  
Laura Cardarelli ◽  
Milena Calderone ◽  
Paola Marin
Keyword(s):  
Sensitivity And Specificity ◽  
Task Force ◽  
False Negative ◽  
Real Life ◽  
Health Surveillance ◽  
Spike Protein ◽  
Rt Pcr ◽  
Test Kit ◽  
Local Company ◽  
Mean Sensitivity

Objectives The aim of this study was to evaluate the clinical performance of the Fluorecare SARS-CoV-2 Spike Protein Test Kit, a rapid immunochromatographic assay for SARS-CoV-2 detection. Moreover, we sought to point out the strategy adopted by a local company to lift the lockdown without leading to an increase in the number of COVID-19 cases, by performing a precise and timely health surveillance. Methods The rapid Fluorecare SARS-CoV-2 Spike Protein Test was performed immediately after sampling following the manufacturer’s instructions. RT-PCRs were performed within 24 hours of specimen collection. A total amount of 253 nasopharyngeal samples from 121 individuals were collected between March 16 and April 2, 2021 and tested. Results Of 253 nasopharyngeal samples, 11 (9.1%) were positive and 242 (90.9%) were negative for SARS-CoV-2 RNA by RT-PCR assays. The rapid SARS-CoV-2 antigen detection test’s mean sensitivity and specificity were 84,6% (95% CI, 54.6–98.1%) and 100% (95% CI, 98.6–100%), respectively. Two false negative test results were obtained from samples with high RT-PCR cycle threshold (Ct). Conclusion Our study suggested that Fluorecare SARS-CoV-2 Spike Protein Test can be introduced into daily diagnostic practice, as its mean sensitivity and specificity follow the standards recommended by WHO and IFCC Task Force. In addition, we underlined how the strategy adopted by a local company to risk assessment and health surveillance was appropriate for infection containment. This real-life scenario gave us the possibility to experience potential approaches aimed to preserve public health and work activities.

scholarly journals Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar

2021 ◽  
Author(s):  
Jesha Mundodan ◽  
Samina Hasnain ◽  
Hayat Khogali ◽  
Soha Shawqi Al Bayat ◽  
Dina Ali ◽  
...  
Keyword(s):  
Predictive Value ◽  
Local Population ◽  
Rapid Test ◽  
Antibody Test ◽  
Molecular Testing ◽  
Rt Pcr ◽  
Test Kit ◽  
Asymptomatic Individuals ◽  
Sensitivity Specificity ◽  
Rapid Antibody

Background: In response to the growing coronavirus disease 2019 (COVID-19) pandemic and the shortage of laboratory based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed rapid and easy to use devices to facilitate testing outside laboratory settings. These kits are either based on detection of proteins from SARS-CoV-2 virus or detection of antigen or human antibodies generated in response to the infection. However, it is important to understand their performance characteristics and they must be validated in the local population setting.Design and Methods: The objective is to assess the validity of the rapid test for IgG and IgM immunoglobulins compared to the current gold standard reverse transcription polymerase chain reaction (RT-PCR) test. A total of 16951 asymptomatic individuals were tested by the Ministry of Public Health track-and-trace team using both rapid immunodiagnostic test and RT-PCR as part of screening across various random settings with potential risk of community interaction prior to gradual lifting of restrictions in Qatar.  Rapid test was considered to be posiive if both IgG and IgM are positive, while only IgG/IgM positive was considered as rapid test negative. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated.Results: The sensitivity of rapid test kit was found to be 0.9%, whereas the specificity was found to be 97.8%. the PPV was found to be 0.3% whereas the NPV was found to be 99.4%.Conclusion: Based on the outcome and results of the study, it appears that the sensitivity and PPV of the rapid antibody test are low. As such, this test is not recommended for use to assist in taking clinic-based decisions or decisions related to quarantine/isolation.

scholarly journals Potential applications of the rapid COVID-19 antibody test kit screening in comparison to the RT-PCR in patients and personnel at the Department of Obstetrics and Gynecology.

2021 ◽  
Author(s):  
Amarin Narkwichean ◽  
Wittaya Jomoui ◽  
Wipada Laosooksathit ◽  
Tanawin Nopsopon ◽  
Krit Pongpirul
Keyword(s):  
False Positive Rate ◽  
Antibody Test ◽  
Medical Personnel ◽  
Obstetrics And Gynecology ◽  
Rt Pcr ◽  
Risk Area ◽  
Asymptomatic Patients ◽  
Test Kit ◽  
Potential Applications ◽  
Rapid Antibody

Objective To explore potential applications of the rapid antibody test for COVID-19 screening, in comparison to RT-PCR, for emergency obstetric and gynecological procedures, and medical personnel in the Department of Obstetrics and Gynecology. Methods A cross-sectional study was conducted in expected 290 participants: 230 patients and 60 medical staff, during the four-month national COVID-19 outbreak period (Aug-Sep 2020, and Dec 2020-Jan 2021). All participants underwent both rapid antibody tests and RT-PCR (at admission for patients). Results A total of 270 participants completed the study. Fever and URI symptoms were present in 6/210 patients (2.8%) while one patient (0.5%) had a history of traveling to a high-risk area. However, only two (1%) asymptomatic patients had positive IgM results. Concerning the medical personnel, 10% fell into the patient under investigation (PUI) category. 4/60 (6.7%) IgM positive was observed in the staff cohort in which 3/4 came from non-PUI participants. Neither participant had RT-PCR positive demonstrating a 1.9% total false positive rate. Conclusion Rapid point-of-care antibody test can be used to screen either a pregnant coming for delivery, a patient who requires urgent/emergency operative procedures, or medical personnel, at least in the defined lower-prevalence COVID-19 situation.

scholarly journals Corticosteroid injections during the COVID-19 pandemic

2020 ◽  
Vol 1 (9) ◽  
pp. 605-611 ◽  
Author(s):  
David McKean ◽  
Siok Li Chung ◽  
Rory Fairhead ◽  
Oliver Bannister ◽  
Malgorzata Magliano ◽  
...  
Keyword(s):  
Observational Study ◽  
Clinical Outcomes ◽  
Antibody Test ◽  
British Society ◽  
Rt Pcr ◽  
Antibody Testing ◽  
Igg Antibody ◽  
Thoracic Imaging ◽  
Polymerase Chain ◽  
Corticosteroid Injections

Aims To describe the incidence of adverse clinical outcomes related to COVID-19 infection following corticosteroid injections (CSI) during the COVID-19 pandemic. To describe the incidence of positive SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) testing, positive SARS-COV2 IgG antibody testing or positive imaging findings following CSI at our institution during the COVID-19 pandemic. Methods A retrospective observational study was undertaken of consecutive patients who had CSI in our local hospitals between 1 February and 30June 2020. Electronic patient medical records (EPR) and radiology information system (RIS) database were reviewed. SARS-CoV-2 RT-PCR testing, SARS-COV2 IgG antibody testing, radiological investigations, patient management, and clinical outcomes were recorded. Lung findings were categorized according to the British Society of Thoracic Imaging (BSTI) guidelines. Reference was made to the incidence of lab-confirmed COVID-19 cases in our region. Results Overall, 1,656 lab-confirmed COVID-19 cases were identified in our upper tier local authority (UTLA), a rate of 306.6 per 100,000, as of 30June 2020. A total of 504 CSI injections were performed on 443 patients between 1 February and 30June 2020. A total of 11 RT-PCR tests were performed on nine patients (2% of those who had CSI), all of which were negative for SARS-CoV-2 RNA, and five patients (1.1%) received an SARS-CoV-2 IgG antibody test, of which 2 (0.5%) were positive consistent with prior COVID-19 infection, however both patients were asymptomatic. Seven patients (1.6%) had radiological investigations for respiratory symptoms. One patient with indeterminate ground glass change was identified. Conclusion The incidence of positive COVID-19 infection following corticosteroid injections was very low in our cohort and no adverse clinical outcomes related to COVID-19 infection following CSI were identified. Our findings are consistent with CSI likely being low risk during the COVID-19 pandemic. The results of this small observational study are supportive of the current multi-society guidelines regarding the judicious use of CSI. Cite this article: Bone Joint Open 2020;1-9:605–611.

scholarly journals LB-12. SARS-CoV-2 RNA and Antibodies among People Experiencing Homelessness and Staying in Shelters or Outdoor Encampments in Denver, Colorado, May-July 2020

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S849-S850
Author(s):  
David McCormick ◽  
Tracy Scott ◽  
Jesse Chavez ◽  
Kay Wilcox ◽  
Grace E Marx ◽  
...  
Keyword(s):  
Native American ◽  
Venous Blood ◽  
Antibody Test ◽  
Sociodemographic Factors ◽  
Mitigation Strategies ◽  
Homeless Shelters ◽  
Test Results ◽  
Rt Pcr ◽  
Antibody Testing ◽  
Antibody Tests

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

scholarly journals Cohort Study: The Accuracy of Screening Methods of COVID-19 in Pregnancy: Practical Approach in Low Resources Health Services

2021 ◽  
Author(s):  
Muhammad Ilham Aldika Akbar ◽  
Khanizyah Erza Gumilar ◽  
Eccita Rahestyningtyas ◽  
Manggala Pasca Wardhana ◽  
Pungky Mulawardhana ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Pregnant Women ◽  
Antibody Test ◽  
Screening Methods ◽  
Rt Pcr ◽  
Predictive Values ◽  
X Ray ◽  
Low Middle Income Countries ◽  
Chest X Ray ◽  
Rapid Antibody

Background All pregnant women in labor should be universally screened for Coronavirus Disease 2019 (COVID-19) during pandemic periods using Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test. In many low-middle income countries, screening method was developed as an initial examination because of limited availability of RT-PCR tests. Objectives This study aims to evaluate the screening methods of COVID-19 accuracy in pregnant women. Material and Methods We recruited all pregnant women with suspicion of COVID-19 from April - August 2020 at Universitas Airlangga hospital, Surabaya, Indonesia. The participant was divided into two groups based on RT-PCR results: COVID-19 and non-COVID-19 group. The proportion of positive signs & symptoms, rapid antibody test, abnormal findings in chest x-ray, and neutrophil to lymphocyte ratio (NLR) value were then compared between both groups. The sensitivity, specificity, positive predictive value (PPV), negative predictive values (NPV), and diagnostic accuracy (DOR) were calculated. Results A total 141 pregnant women with suspected COVID-19 cases were recruited for this study. This consist of 62 COVID-19 cases (43.9%) and 79 non COVID-19 pregnant women (56.1%). The sensitivity, spesificity, PPV, NPV, and diagnostic accuracy of each parameter are as follow: clinical sign & symptoms (24.19%, 75.95%, 3.92%, 96.11%, 65.87%), rapid antibody test (72.73%, 35.06%, 4.35%, 96.94%, 36.53%), chest x-ray (40.68%, 59.45%, 3.92%, 96.11%, 58.76%), and NLR > 5.8 (41.38%, 72%, 5.66%, 96.80%, 70.81%). Conclusions The use of combined screening methods can classify pregnant women with high-risk COVID-19 before definitively diagnosed with RT-PCR. This practice will help to reduce RT-PCR need in a limited resources country.

scholarly journals Real-world assessment of Fluorecare SARS-CoV-2 Spike Protein Test Kit

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Gian Luca Salvagno ◽  
Gianluca Gianfilippi ◽  
Laura Pighi ◽  
Simone De Nitto ◽  
Brandon M. Henry ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Diagnostic Testing ◽  
Real Life ◽  
Spike Protein ◽  
Nasopharyngeal Swab ◽  
Molecular Testing ◽  
Diagnostic Efficiency ◽  
Predictive Values ◽  
Test Kit ◽  
Study Population

Abstract Objectives Since commercial SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antigen rapid detection tests (Ag-RDTs) display broad diagnostic efficiency, this study aimed to evaluate the clinical performance of Fluorecare SARS-CoV-2 Spike Protein Test Kit in a real-life scenario. Methods The study population consisted of a series of patients undergoing SARS-Cov-2 diagnostic testing at Pederzoli Hospital of Peschiera del Garda (Verona, Italy). A nasopharyngeal swab was collected upon hospital admission and assayed with molecular (Altona Diagnostics RealStar® SARSCoV-2 RT-PCR Kit) and antigen (Fluorecare SARS-CoV-2 Spike Protein Test Kit) tests. Results The study population consisted of 354 patients (mean age, 47 ± 20 years; 195 women, 55.1%), 223 (65.8%) positive at molecular testing. A significant correlation was found between Fluorecare SARS-CoV-2 Spike Protein Test Kit and Altona (both S and E genes: r=−0.75; p<0.001). The cumulative area under the curve in all nasopharyngeal samples was 0.68. At ≥1.0 S/CO manufacturer’s cut-off, the sensitivity, specificity, negative and positive predictive values were 27.5, 99.2, 41.5 and 98.5%, respectively. Considerable improvement of sensitivity was observed as Ct values decreased, becoming 66.7% in samples with mean Ct values <30, 90.5% in those with mean Ct values <25, up to 100% in those with mean Ct values <20. Conclusions The modest sensitivity and negative predictive value of Fluorecare SARS-CoV-2 Spike Protein Test Kit makes unadvisable to use this assay as surrogate of molecular testing for definitively diagnosing SARS-CoV-2 infection, though its suitable sensitivity at high viral load could make it a reliable screening test for patients with higher infective potential.

scholarly journals Updated Clinical Evaluation of the CLUNGENE® Rapid COVID-19 Antibody Test

Healthcare ◽  
2021 ◽  
Vol 9 (9) ◽  
pp. 1124
Author(s):  
Christopher C. Lamb ◽  
Fadi Haddad ◽  
Christopher Owens ◽  
Alfredo Lopez-Yunez ◽  
Marion Carroll ◽  
...  
Keyword(s):  
False Positive ◽  
Point Of Care ◽  
Rapid Test ◽  
Antibody Test ◽  
Cross Reactivity ◽  
Blood Collection ◽  
Rt Pcr ◽  
Antibody Testing ◽  
Reactivity Study ◽  
Positive Results

Background: COVID-19 antibody testing has been shown to be predictive of prior COVID-19 infection and an effective testing tool. The CLUNGENE® SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette was evaluated for its utility to aide healthcare professionals. Method: Two studies were performed by using the CLUNGENE® Rapid Test. (1) An expanded Point-of-Care (POC) study at two clinical sites was conducted to evaluate 99 clinical subjects: 62 positive subjects and 37 negative subjects were compared to RT-PCR, PPA, and NPA (95% CI). Sensitivity was calculated from blood-collection time following symptom onset. (2) A cross-reactivity study was performed to determine the potential for false-positive results from other common infections. Results: The specificity of subjects with confirmed negative COVID-19 by RT-PCR was 100% (95% CI, 88.4–100.0%). The sensitivity of subjects with confirmed positive COVID-19 by RT-PCR was 96.77% (95% CI, 88.98–99.11%). In the cross-reactivity study, there were no false-positive results due to past infections or vaccinations unrelated to the SARS-CoV-2 virus. Conclusion: There is a need for a rapid, user-friendly, and inexpensive on-site monitoring system for diagnosis. The CLUNGENE® Rapid Test is a useful diagnostic test that provides results within 15 min, without high-complexity laboratory instrumentation.

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