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

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.

Author(s):  
Jesha Mundodan ◽  
Samina Hasnain ◽  
Hayat Khogali ◽  
Soha Shawqi Al Bayat ◽  
Dina Ali ◽  
...  

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.


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


Healthcare ◽  
2021 ◽  
Vol 9 (9) ◽  
pp. 1124
Author(s):  
Christopher C. Lamb ◽  
Fadi Haddad ◽  
Christopher Owens ◽  
Alfredo Lopez-Yunez ◽  
Marion Carroll ◽  
...  

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.


2021 ◽  
Author(s):  
Monica Irungbam ◽  
Anubhuti Chitkara ◽  
Vijay Kumar Singh ◽  
Subash Chandra Sonkar ◽  
Abhisekh Dubey ◽  
...  

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.


Author(s):  
Yoshifumi Uwamino ◽  
Masatoshi Wakui ◽  
Wataru Aoki ◽  
Toshinobu Kurafuji ◽  
Emmy Yanagita ◽  
...  

Background: The usability of laboratory tests related to SARS-CoV-2 is critically important for the world undergoing the COVID-19 pandemic. The present study aimed to assess diagnostic usability of rapid tests for detection of antibody against SARS-CoV-2 through comparison of their results with results of RT-PCR test for detection of SARS-CoV-2 genomic RNA and with results of a quantitative test for antibody detection. Methods: Serum samples were collected from eighteen patients undergoing RT-PCR testing for SARS-CoV-2. Twelve patients were RT-PCR positive while six were negative. A quantitative test based on chemiluminescent immunoassay and three rapid tests based on immunochromatography were performed to detect anti-SARS-CoV-2 IgG and IgM. Results: All the antibody tests exhibited poor sensitivity at the timing of initial RT-PCR diagnosis. IgG responses occurring prior to or simultaneously with IgM responses were observed through not only the quantitative test but also the three rapid tests. Based on concordance with the quantitative test results, the large variance among the three rapid tests was revealed. Conclusions: All antibody tests were unsatisfactory to replace RT-PCR for early diagnosis of COVID-19. Rapid antibody tests as well as a quantitative antibody test were useful in assessment of immune responses in COVID-19. The obvious variance among the three rapid tests suggested limited accuracy and difficult standardization. Diagnostic usability of rapid antibody tests for COVID-19 should be investigated rigorously.


Author(s):  
Mehal Churiwal ◽  
Kelly D. Lin ◽  
Salman Khan ◽  
Srijana Chhetri ◽  
Meredith S. Muller ◽  
...  

Point-of-care (POC) tests to detect SARS-CoV-2 antibodies offer quick assessment of serostatus after natural infection or vaccination. We compared the field performance of the BioMedomics COVID-19 IgM/IgG Rapid Antibody Test against an ELISA in 303 participants enrolled in a SARS-CoV-2 household cohort study. The rapid antibody test was easily implemented with consistent interpretation across 14 users in a variety of field settings. Compared with ELISA, detection of seroconversion lagged by 5 to 10 days. However, it retained a sensitivity of 90% (160/177, 95% confidence interval [CI] 85–94%) and specificity of 100% (43/43, 95% CI 92–100%) for those tested 3 to 5 weeks after symptom onset. Sensitivity was diminished among those with asymptomatic infection (74% [14/19], 95% CI 49–91%) and early in infection (45% [29/64], 95% CI 33–58%). When used appropriately, rapid antibody tests offer a convenient way to detect symptomatic infections during convalescence.


2020 ◽  
Author(s):  
Rama Vancheeswaran ◽  
Merlin L Willcox ◽  
Beth Stuart ◽  
Matthew Knight ◽  
Hala Kandil ◽  
...  

AbstractObjectivesTo assess the real-world diagnostic accuracy of the Livzon point-of-care rapid test for antibodies to SARS-COV-2DesignProspective cohort studySettingDistrict general hospital in EnglandParticipants173 Patients and 224 hospital staff with a history of COVID-19 symptoms, and who underwent PCR and/or reference antibody testing for COVID-19.InterventionsThe Livzon point-of-care (POC) lateral flow immunoassay rapid antibody test (IgM and IgG) was conducted at least 7 days after onset of symptoms and compared to the composite reference standard of PCR for SARS-COV-2 plus reference laboratory testing for antibodies to SARS-COV-2. The SARS-CoV-2 RT-PCR was tested using the available molecular technology during the study time (PHE laboratories, GeneXpert® system Xpert, Xpress SARS-CoV-2 and Source bioscience laboratory). All molecular platforms/assays were PHE/NHSE approved. The reference antibody test was the Elecsys Anti-SARS-CoV-2 assay (Roche diagnostics GmBH).Main outcome measuresSensitivity and specificity of the rapid antibody testResultsThe reference antibody test was positive in 190/268 (70.9%) of participants with a history of symptoms suggestive of COVID-19; in the majority (n=312) the POC test was taken 35 days or more after onset of symptoms. The POC antibody test had an overall sensitivity of 90.1% (292/328, 95% CI 86.3 – 93.1) and specificity of 100% (68/68, 95% CI 94.7 - 100) for confirming prior SARS-CoV-2 infection when compared to the composite reference standard. Sensitivity was 97.8% (89/92, 95% CI 92.3% to 99.7%) in participants who had been admitted to hospital and 84.4% (124/147, 95% CI 77.5% to 89.8%) in those with milder illness who had never been seen in hospital.ConclusionsThe Livzon point-of-care antibody test had comparable sensitivity and specificity to the reference laboratory antibody test, so could be used in clinical settings to support decision-making about patients presenting with more than 10 days of symptoms of COVID-19.What is already known on this topic-Presence of IgG and IgM antibodies to SARS-COV-2 indicates that the person was infected at least 7 days previously and is usually no longer infectious.-Rapid point-of-care tests for antibodies to SARS-COV-2 are widely available, cheap and easy to use-Preliminary evaluations suggested that rapid antibody tests may have insufficient accuracy to be useful for testing individual patients.What this study adds-The rapid point-of-care test for antibodies to SARS-COV-2 was 90.1% sensitive and 100% specific compared to reference standards for prior infection with COVID-19.-This is comparable to reference antibody tests-The point-of-care test evaluated in this study could be used to support clinical decision-making in real time, for patients presenting with symptoms of possible COVID-19 with at least 10 days of symptoms.


Diagnostics ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 1441
Author(s):  
Suelen Basgalupp ◽  
Giovana dos Santos ◽  
Marina Bessel ◽  
Lara Garcia ◽  
Ana Carolina de Moura ◽  
...  

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.


2021 ◽  
Author(s):  
Amarin Narkwichean ◽  
Wittaya Jomoui ◽  
Wipada Laosooksathit ◽  
Tanawin Nopsopon ◽  
Krit Pongpirul

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.


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