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

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.

Author(s):  
Liu Ying ◽  
Liu Yue-ping ◽  
Diao Bo ◽  
Ren Feifei ◽  
Wang Yue ◽  
...  

[Abstract]ObjectiveCoronavirus disease 2019 (COVID-19) has become pandemic in the world. The need for IgG-IgM combined antibody test is booming, but data on diagnostic indexes evaluation was inadequate. The aim of this study was to evaluate diagnostic indexes of a rapid IgG-IgM combined antibody test for SARS-CoV-2.MethodsA total of 179 patients were enrolled. Serum were collected for IgG-IgM combined antibody test and corresponding nasal and pharyngeal swab specimens were collected for SARS-CoV-2 RT-PCR. According to SARS-CoV-2 RT-PCR results, patients under study were categorized as PCR positive group in 90 patients and PCR negative group in 89 patients.Results1. Of the 90 PCR positive samples, 77 were tested positive by SARS-CoV-2 IgG-IgM test kit, yielding a sensitivity of 85.6%. Meanwhile, of the 89 PCR negative sample, 8 samples were detected positive, resulting in a specificity of 91%. Positive predictive value, negative predictive value and accuracy of this test kit was 95.1%, 82.7%, and 88.3%, respectively. Kappa efficiency between IgG/IgM test kit and RT-PCR were 0.75. 2. Accuracy in mild/common and severe/critical subgroup were 73.9% and 97.7%, respectively. Accuracy in clinical confirmed, suspected cases and other disease subgroups were 70%, 60%, and 100%, respectively. 3. Patients were further divided into ‘0 - 7’, ‘8 - 15’ and ‘>= 16’ groups according to the time from illness onset to sample collection. Sensitivity, specificity and accuracy in these three groups were 18.8%, 77.8% and 40%; 100%, 50% and 87.5%; 100%, 64.3%, and 93.9, respectively.ConclusionThe sensitivity and specificity of this ease-of-use IgG/IgM combined test kit were adequate, plus short turnaround time, no specific requirements for additional equipment or skilled technicians, all of these collectively contributed to its competence for mass testing. At the current stage, it cannot take the place of SARA-CoV-2 nucleic acid RT-PCR, but can be served as a complementary option for RT-PCR. The combination of RT-PCR and IgG-IgM combined test kit could provide further insight into SARS-CoV-2 infection diagnosis.


2020 ◽  
Author(s):  
Tenzin Tenzin ◽  
Kelzang Lhamo ◽  
Purna B Rai ◽  
Dawa Tshering ◽  
Pema Jamtsho ◽  
...  

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


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.


2009 ◽  
Vol 3 (1) ◽  
pp. 14-18 ◽  
Author(s):  
George A Alemnji ◽  
Gisele A Ngulefac ◽  
Peter M Ndumbe ◽  
Tazoacha Asonganyi

As programs to prevent and care for HIV-infected persons are scaled-up in Africa, there is the need for continuous evaluation of the performance of test kits that could best support these programs. The present study evaluated the sensitivity, specificity, ease of use, and cost of AWARE TM Blood Serum Plasma (BSP) and Oral Mucosal Transudate (OMT) Rapid HIV-1/2 test kits using real-time and archived samples of HIV-infected persons from Cameroon. Matched whole blood and OMT specimens were collected prospectively from HIV-positive and HIV-negative persons from different regions of Cameroon and tested using the AWARE TM BSP and OMT test kits, respectively. These results were compared to the gold standard that included a combination of Determine HIV-1/2 and Enzygnost HIV-1/2. The BSP Rapid test kit was further evaluated using well characterized panels of HIV-2 and HIV-1 group O samples. Cost and end-user analysis of the OMT test kit was done by comparing its actual cost, consumables, safety, bench time and manipulation with other test kits. Of the 732 matched samples, 412 (56.3%) and 320 (43.7%) were from females and males, respectively. Of these samples, 23 (3.1%) gave discordant results between Determine HIV-1/2 and Enzygnost HIV1/2 and were excluded from the analysis. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AWARETM BSP were 100%. The AWARETM OMT had 98.8% sensitivity, 98.9% specificity, 98.0% PPV and 99.4% NPV. The results of a well-characterized archived panel of HIV-2 (n=7) and HIV-1 group O (n=3) samples using the AWARETM BSP Rapid test kit gave 100% concordance. Total per patient cost of the AWARE OMT rapid test kit was US$4.72 compared to a mean cost of US $7.33 + 0.11 for the other test kits. Both the AWARETM BSP and OMT Rapid test kits demonstrated high sensitivities and specificities on all samples tested and were well adapted for use in resource-constrained settings with high HIV heterogeneity such as Cameroon. The AWARE TM HIV-1/2 OMT Rapid test kit appears to be the cheapest, safest and easiest to use compared with other available test kits.


2020 ◽  
Author(s):  
Tenzin Tenzin ◽  
Kelzang Lhamo ◽  
Purna B Rai ◽  
Dawa Tshering ◽  
Pema Gyamtsho ◽  
...  

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


2020 ◽  
Vol 11 ◽  
Author(s):  
Moïse Michel ◽  
Amar Bouam ◽  
Sophie Edouard ◽  
Florence Fenollar ◽  
Fabrizio Di Pinto ◽  
...  

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


2021 ◽  
Vol 10 (4) ◽  
pp. 758
Author(s):  
Atikah Nurhesti ◽  
Solikhah Solikhah ◽  
Siti Nur Djannah

Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Antibody rapid test is one of the COVID-19 screening tests that can be used in the community. The accuracy of the rapid antibody methods needs to be appropriately assessed, it is necessary to carry out a diagnostic accuracy study using a pairwise sensitivity and specificity analysis. This research aimed to assess the sensitivity and specificity of COVID-19 rapid tests, also assesses positive predictive value (PPV) and negative predictive value (NPV) of the rapid antibody test as a method of screening for COVID-19 in Sleman Regency, Indonesia. In total, 118 respondents who have contact with COVID-19 patients and have symptoms were enrolled in this study. The study was conducted on 118 patients who had been in contact with confirmed COVID-19 118 patients who met the close contact criteria were conducted a rapid antibody test. 64.41% patients were reactive. Real-time polymerase chain reaction (RT PCR) as a gold standard was also carried out for all patients and 63.56% affirmed positive for COVID-19. The sensitivity value was 97.33%, and the specificity value was 93.02%, while the positive predictive value (NPP) was 96.05%, and the negative predictive value (NPN) was 95.24%. These results meet the minimum recommendations for the screening method.


Author(s):  
İlker Kızıloglu ◽  
Aslı Şener ◽  
Neslihan Siliv

Introduction: In this study, it is planned to compare the RT-PCR test, which is the gold standard in the diagnosis of COVID-19, with Thorax computed tomography (CT) and rapid antibody test results. Methods: Patients who were admitted to the emergency service of İzmir Çiğli Training and Research Hospital between 01.04.2020 and 31.05.2020 and who were suspected of having COVID-19 infection were included in the study. The medical records of the patients were retrospectively analyzed through the hospital data processing database. Age, gender, hospitalization, status of home quarantine, real-time reverse transcription-polymerase chain reaction (RT-PCR), thorax CT and rapid antibody test results of the patients were examined. The relationship between RT-PCR, thorax CT and rapid antibody test results were compared statistically. Results: A total of 181 patients, 115 (63.5%) male and 66 (36.5%) female, with an average age of 56.4 ± 18.06 years were included in the study. The nasopharyngeal swab PCR result obtained at the first admission of the patients to the emergency department was positive in 71 (39.2%) patients. Thorax CT was performed in 173 (95.6%) patients who applied to the emergency department, and 112 (64.7%) of them had findings that could be compatible with COVID-19. According to the thorax CT findings in patients, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for detecting COVID-19 infection were respectively; 76.1%, 43.1%, 48.2% and 72.1% (ĸ: 0.176, p <0.001). In our study, the mortality rate for COVID-19 was found to be 2.8%. Conclusion: Rapid antibody test and thorax CT examinations were found to have low diagnostic value in patients who admitted to the emergency department of our hospital and whose first RT-PCR SARS-CoV-2 test was positive. Studies involving larger patient groups are needed for their use alone in diagnosis and screening.


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.


2021 ◽  
Vol 18 (2) ◽  
pp. 78-83
Author(s):  
Fenty Fenty ◽  
Ivan Lim ◽  
Frida E.W. ◽  
Kristiani D. ◽  
Rizaldi Pinzon

Since March 2020, Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection has been around in Indonesia with a case fatality rate was 4.7% on August, 1th 2020. So far, the Real-Time Polymerase Chain Reaction (RT-PCR) method is the gold standard for the SARS-CoV-2 infection diagnosis. This method, however, has some limitations where it has a long turnaround time, complicated operations, and high prices. Hence, the rapid test kits are now readily available to identify the SARS-CoV-2 patients. The purpose of this study is to measure the diagnostic performance, including sensitivity, specificity, positive and negative predictive value, likelihood ratio or LR of antibody rapid test if compared with RT-PCR for the SARS-CoV-2 suspected patients in Bethesda Hospital Yogyakarta. This research was analytical observational research with a cross-sectional design approach, in which data were collected retrospectively. The instruments used in this study included e-medical record (ERM), Laboratory Information System (LIS) data from patients with suspected SARS-CoV-2 infection in Bethesda Hospital Yogyakarta. We collected demographic data of patients, RT-PCR results, antibody rapid test results using Standard Q COVID-19 IgM/IgG Combo. The data were obtained from 50 patients. The results showed that the Rapid test kit has a 100% sensitivity value, 74.4% specificity value, 38.9% positive and 100% negative predictive value, 3906 positive likelihood ratio compared with the RT-PCR results.


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