scholarly journals The role of rapid diagnostic point of care IgG/IgM antibody tests in the diagnosis of SARS-CoV-2 infection

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Nishita Tripathi ◽  
Keyword(s):  
Nucleic Acid ◽  
Point Of Care ◽  
Clinical Importance ◽  
Antibody Test ◽  
High Specificity ◽  
Nucleic Acid Amplification ◽  
Serological Tests ◽  
Nucleic Acid Amplification Tests ◽  
Igm Antibody ◽  
Antibody Tests

Background: Current testing of symptomatic patients for SARS-CoV-2 involves the use of nucleic acid amplification tests, also known as genetic, RNA or PCR to detect viral RNA. The initial use of point-of-care (POC) antibody tests, also known as serological tests in the management of SARS-CoV-2 infection was limited. In this review, we determine the significance of POC antibody serological tests and explore their possible role in the diagnosis and management of patients infected with SARS-CoV-2 virus. Methods: A literature search was conducted in Google Scholar, PubMed, and Embase, and supplemented by searching the Center for Disease Control (CDC), and the Infectious Diseases Society of America (IDSA) websites. We identified 7 articles published in the last 6 months pertaining to the keywords. The sensitivity and specificity of the IgG/IgM antibody tests obtained from these studies were compared and used to determine the clinical importance of the rapid diagnostic antibody test in SARS-CoV-2 infection. Results: Through the literature review, it was found that POC diagnostic antibody tests can be used as an adjuvant with the nucleic acid amplification tests in determining both active and post-exposure antibodies. These rapid antibody IgG/IgM tests had high sensitivity, the ability of a test to correctly identify those with the disease, and high specificity, the ability of the test to correctly identify those without the disease. Conclusion: Emerging studies indicate the importance of POC antibody serological testing as an important diagnostic tool in the current SARS-CoV-2 pandemic. Considering the limitations of the molecular methods of testing, POC antibody tests can help reduce dependency on the molecular assays of testing when used in conjunction with them.

scholarly journals A systematic review and meta-analysis of the sensitivity of antibody tests for the laboratory confirmation of COVID-19

2021 ◽  
Author(s):  
Nigel A Makoah ◽  
Thomas Tipih ◽  
Matefo M Litabe ◽  
Mareza Brink ◽  
Joseph B Sempa ◽  
...  
Keyword(s):  
Systematic Review ◽  
Nucleic Acid ◽  
Symptom Onset ◽  
Meta Analysis ◽  
Nucleic Acid Amplification ◽  
Serological Tests ◽  
Nucleic Acid Amplification Tests ◽  
Laboratory Confirmation ◽  
Using Data ◽  
Low Sensitivity

Aim: The aim of this study was to investigate the utility of serological tests for the diagnosis of COVID-19 during the first week of symptom onset in patients confirmed with the real-time RT-PCR. Materials & methods: A systematic review and meta-analysis of 58 publications were performed using data obtained from Academic Search Ultimate, Africa-wide, Scopus, Web of Science and MEDLINE. Results: We found that the highest pooled sensitivities were obtained with ELISA IgM-IgG and chemiluminescence immunoassay IgM tests. Conclusion: Serological tests have low sensitivity within the first week of symptom onset and cannot replace nucleic acid amplification tests. However, serological assays can be used to support nucleic acid amplification tests.

Paper-based nucleic acid amplification tests for point-of-care diagnostics

The Analyst ◽  
2018 ◽  
Vol 143 (10) ◽  
pp. 2213-2234 ◽  
Author(s):  
Navjot Kaur ◽  
Bhushan J. Toley
Keyword(s):  
Nucleic Acid ◽  
Critical Review ◽  
Point Of Care ◽  
Nucleic Acid Amplification ◽  
Nucleic Acid Amplification Tests ◽  
Point Of Care Diagnostics

A critical review of paper-based nucleic acid amplification tests with a focus on integration and sequence of operations.

scholarly journals Clinical evaluation of fully automated molecular diagnostic system “Simprova” for influenza virus, respiratory syncytial virus, and human metapneumovirus

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Ikuyo Takayama ◽  
Shohei Semba ◽  
Kota Yokono ◽  
Shinji Saito ◽  
Mina Nakauchi ◽  
...  
Keyword(s):  
Influenza Virus ◽  
Respiratory Syncytial Virus ◽  
Nucleic Acid ◽  
Point Of Care ◽  
Antigen Detection ◽  
Human Metapneumovirus ◽  
Nucleic Acid Amplification ◽  
Clinical Specimens ◽  
Nucleic Acid Amplification Tests ◽  
Syncytial Virus

Abstract Influenza virus, respiratory syncytial virus, and human metapneumovirus commonly cause acute upper and lower respiratory tract infections, especially in children and the elderly. Although rapid antigen detection tests for detecting these infections have been introduced recently, these are less sensitive than nucleic acid amplification tests. More recently, highly sensitive point-of-care testings (POCTs) have been developed based on nucleic acid amplification tests, which are easy to use in clinical settings. In this study, loop-mediated isothermal amplification (LAMP)-based POCT “Simprova” to detect influenza A and B viruses, respiratory syncytial virus, and human metapneumovirus was developed. Simprova system is fully automated and does not require skilled personnel. In addition, positive results can be achieved faster than with PCR. In this study, the accuracy of the POCT was retrospectively analyzed using 241 frozen stocked specimens. Additionally, the usability of the Simprova at clinical sites was assessed in a prospective clinical study using 380 clinical specimens and compared to those of real-time PCR and rapid antigen detection test. The novel LAMP-based POCT demonstrated high sensitivity and specificity in characterizing clinical specimens from patients with influenza-like illnesses. The Simprova is a powerful tool for early diagnosis of respiratory viral infections in point-of-care settings.

scholarly journals Advances Afoot in Microbiology

2017 ◽  
Vol 55 (7) ◽  
pp. 1984-1988 ◽  
Author(s):  
Robin Patel ◽  
Brad S. Karon
Keyword(s):  
Nucleic Acid ◽  
American Academy ◽  
Medical Care ◽  
Clinical Microbiology ◽  
Point Of Care ◽  
Nucleic Acid Amplification ◽  
Nucleic Acid Amplification Tests ◽  
Link Type ◽  
The Government

ABSTRACT In 2016, the American Academy of Microbiology convened a colloquium to examine point-of-care (POC) microbiology testing and to evaluate its effects on clinical microbiology. Colloquium participants included representatives from clinical microbiology laboratories, industry, and the government, who together made recommendations regarding the implementation, oversight, and evaluation of POC microbiology testing. The colloquium report is timely and well written (V. Dolen et al., Changing Diagnostic Paradigms for Microbiology , 2017, https://www.asm.org/index.php/colloquium-reports/item/6421-changing-diagnostic-paradigms-for-microbiology?utm_source=Commentary&utm_medium=referral&utm_campaign=diagnostics ). Emerging POC microbiology tests, especially nucleic acid amplification tests, have the potential to advance medical care.

scholarly journals Comparative performance of four nucleic acid amplification tests for SARS-CoV-2 virus

2020 ◽  
Author(s):  
Yujuan Xiong ◽  
Zhen-Zhen Li ◽  
Qi-Zhen Zhuang ◽  
Yan Chao ◽  
Fei Li ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Limit Of Detection ◽  
High Specificity ◽  
Nucleic Acid Amplification ◽  
Virus Concentration ◽  
Analytical Sensitivity ◽  
Comparative Performance ◽  
Consistency Test ◽  
Nucleic Acid Amplification Tests ◽  
Selection Of

AbstractCoronavirus disease 2019 (COVID-19) can be screened and diagnosed through the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by real-time reverse transcription polymerase chain reaction. SARS-CoV-2 nucleic acid amplification tests (NAATs) have been rapidly developed and quickly applied to clinical testing during the pandemic. However, studies evaluating the performance of these NAAT assays are limited. We evaluated the performance of four NAATs, which were marked by the Conformité Européenne and widely used in China during the pandemic. Results showed that the analytical sensitivity of the four assays was significantly lower than that claimed by the NAAT manufacturers. The limit of detection (LOD) of Daan, Sansure, and Hybribio NAATs was 3000 copies/mL, whereas the LOD of Bioperfectus NAATs was 4000 copies/mL. The results of the consistency test using 46 samples showed that Daan, Sansure, and Hybribio NAATs could detect the samples with a specificity of 100% (30/30) and a sensitivity of 100% (16 /16), whereas Bioperfectus NAAT detected the samples with a specificity of 100% (30/30) and a sensitivity 81.25% (13/16). The sensitivity of Bioperfectus NAAT was lower than that of the three other NAATs; this finding was consistent with the result that Bioperfectus NAAT had a higher LOD than the three other kinds of NAATs. The four above mentioned reagents presented high specificity; however, for the detection of the samples with low virus concentration, Bioperfectus reagent had the risk of missing detection. Therefore, the LOD should be considered in the selection of SARS-CoV-2 NAATs.

scholarly journals Antibody tests in detecting SARS-CoV-2 infection: a meta-analysis

2020 ◽  
Author(s):  
Panagiota I Kontou ◽  
Georgia G Braliou ◽  
Niki L Dimou ◽  
Georgios Nikolopoulos ◽  
Pantelis G Bagos
Keyword(s):  
Diagnostic Tests ◽  
Point Of Care ◽  
Meta Analysis ◽  
High Specificity ◽  
Enzyme Linked Immunosorbent Assay ◽  
Lower Sensitivity ◽  
Serological Tests ◽  
Bivariate Method ◽  
Acid Test ◽  
Antibody Tests

SummaryBackgroundWith the emergence of SARS-CoV-2 and the associated Coronavirus disease 2019 (COVID-19), there is an imperative need for diagnostic tests that can identify the infection. Although Nucleic Acid Test (NAT) is considered to be the gold standard, serological tests based on antibodies could be very helpful. However, individual studies measuring the accuracy of the various tests are usually underpowered and inconsistent, thus, a comparison of different tests is needed.MethodsWe performed a systematic review and meta-analysis following the PRISMA guidelines. We conducted the literature search in PubMed, medRxiv and bioRxiv. For the statistical analysis we used the bivariate method for meta-analysis of diagnostic tests pooling sensitivities and specificities. We evaluated IgM and IgG tests based on Enzyme-linked immunosorbent assay (ELISA), Chemiluminescence Enzyme Immunoassays (CLIA), Fluorescence Immunoassays (FIA) and the point-of-care (POC) Lateral Flow Immunoassays (LFIA) that are based on immunochromatography.FindingsIn total, we identified 38 eligible studies that include data from 7,848 individuals. The analyses showed that tests using the S antigen are more sensitive than N antigen-based tests. IgG tests perform better compared to IgM ones, and show better sensitivity when the samples were taken longer after the onset of symptoms. Moreover, irrespective of the method, a combined IgG/IgM test seems to be a better choice in terms of sensitivity than measuring either antibody type alone. All methods yielded high specificity with some of them (ELISA and LFIA) reaching levels around 99%. ELISA- and CLIA-based methods performed better in terms of sensitivity (90-94%) followed by LFIA and FIA with sensitivities ranging from 80% to 86%.InterpretationELISA tests could be a safer choice at this stage of the pandemic. POC tests (LFIA), that are more attractive for large seroprevalence studies show high specificity but lower sensitivity and this should be taken into account when designing and performing seroprevalence studies.FundingNone

scholarly journals Kontroversi Metode Deteksi COVID-19 di Indonesia

2020 ◽  
Vol 2 (1) ◽  
pp. 32
Author(s):  
Mariana Wahjudi
Keyword(s):  
Polymerase Chain Reaction ◽  
Nucleic Acid ◽  
Rna Virus ◽  
Rapid Test ◽  
Nucleic Acid Amplification ◽  
Viral Dynamics ◽  
Chain Reaction ◽  
Serological Tests ◽  
Nucleic Acid Amplification Tests ◽  
Polymerase Chain

Abstract—The governance of COVID-19 cases in Indonesia is carried out in accordance with the WHO directions. Serological tests, often mentioned as rapid antibody tests, are used for mass screening testing while the polymerase-chain-reaction (PCR)-based tests are performed for routine confirmation of COVID-19 infection cases. PCR test is one of nucleic acid amplification tests (NAAT) for detection of viral RNA. The management of the COVID-19 detection caused controversies at the beginning of pandemic period. It seems that the controversies occurred due to misperception regarding the tests, as well as misunderstanding caused by differences in individual immune responses, viral dynamics in human bodies and clinical outcomes. In response to community opinion controversies, this paper discuss the following topics, i.e. a glimpse about COVID-19, the characteristics of SARS-CoV-2, viral dynamics in human body, the dynamics of human immune response to SARS-CoV-2, basic explanation about COVID-19 and SARS-CoV-2 testing, and the last part explained the occurred controversies. Keywords: Indonesia, polymerase chain reaction, rapid test, SARS-CoV-2, serology Abstrak— Penetapan pelaksanaan deteksi kasus COVID-19 di Indonesia dilaksanakan sesuai arahan WHO. Uji serologis atau rapid test antibodi digunakan untuk test atau skrining massal sedangkan untuk uji berbasis polymerase-chain-reaction (PCR) digunakan untuk konfirmasi rutin kasus infeksi COVID-19. Uji molekuler secara PCR merupakan salah satu metode nucleic acid amplification tests (NAAT), untuk mendeteksi RNA virus. Penatalaksanaan deteksi Coronavirus disease 2019 (COVID-19) ini di awal masa pandemik menimbulkan berbagai kontroversi di masyarakat. Kontroversi terjadi terutama karena pemahaman yang berbeda dari masyarakat mengenai prinsip pengujian dan adanya salah pengertian akibat adanya perbedaan respon immun antar individu, dinamika virus COVID-19 dalam tubuh orang terinfeksi, dan luaran klinis pasien. Menanggapi kontroversi pendapat di masyarakat maka pada tulisan ini dibahas tentang sekilas COVID-19, karakteristik SARS-CoV-2, dinamika virus dan pembentukan antibodi dalam tubuh manusia, penjelasan prinsip pengujian COVID-19 dan SAR-CoV-2 serta ulasan tentang kontroversi yang terjadi. Kata kunci: Indonesia, polymerase chain reaction, rapid test, SARS-CoV-2, serology

scholarly journals Utility of Point-of-Care COVID-19 Testing in an Outpatient Otolaryngology clinic

OTO Open ◽  
2021 ◽  
Vol 5 (4) ◽  
pp. 2473974X2110493
Author(s):  
Meera Ganesh ◽  
Craig Cameron Brawley ◽  
Ashoke Khanwalkar ◽  
John Mycanka ◽  
David B. Conley ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Odds Ratio ◽  
Point Of Care ◽  
Nucleic Acid Amplification ◽  
Advanced Practice ◽  
Provider Type ◽  
Chi Square ◽  
Level Of Evidence ◽  
Nucleic Acid Amplification Tests ◽  
Polymerase Chain

Objective To evaluate the utility of point-of-care COVID-19 testing for identifying infected patients in an otolaryngology practice. Study Design Retrospective review of 947 patients tested with a point-of-care nucleic acid amplification test for SARS-CoV-2 (Abbott ID Now). Setting Tertiary otolaryngology clinic setting from July to November 2020. Methods Tests were characterized by provider-specified indication (symptomatic, preprocedural, and universal), subspecialty, provider type, and contemporaneous regional COVID-19 positivity rate, defined as 12%. Positive results were further classified as true or false positive (TP or FP) based on repeat polymerase chain reaction testing wherever available, and true positivity rates were compared among groups by multiway chi-square and Fisher’s exact tests. FP rates within 48 hours of a TP result were also evaluated to assess for batch contamination. Results A total of 947 SARS-CoV-2 nucleic acid amplification tests were performed, yielding 9 TPs (0.95%) and 5 FPs (0.53%). TP rates were significantly different by testing indication, with higher rates among symptomatic patients ( P = .012; vs universal, odds ratio = 7.86 [95% CI, 1.27-83.52]; vs preprocedural, odds ratio = 4.91 [95% CI, 0.79-52.17]); by subspecialty ( P = .011), as driven by higher positivity rates in laryngology; and by encounter, with higher rates among advanced practice practitioners than physicians ( P = .002; odds ratio = 9.97 [95% CI, 2.11-51.16]). TP rates were not significantly different during periods of uncontrolled local outbreak ( P = .660). FP rates were not significantly higher within a 48-hour window of a TP ( P = .192). Conclusion Point-of-care COVID-19 nucleic acid amplification tests in an outpatient otolaryngology clinic identified a low TP rate (<1%) with most cases being clinically suspected. Laryngology and advanced practice practitioner encounters may have higher positivity rates. Level of evidence: 3.

Sign in / Sign up

Export Citation Format

Share Document