scholarly journals Optimize Clinical Laboratory Diagnosis of COVID-19 from Suspect Cases by Likelihood Ratio of SARS-CoV-2 IgM and IgG antibody

Author(s):  
Feng Yangchun

ObjectiveTo optimize clinical laboratory diagnosis of COVID-19 from suspect cases by Likelihood Ratio of SARS-CoV-2 IgM and IgG antibody.MethodsBy reinterpreting the data in the article “Diagnostic Value of Combined Detection of Serum 2019 novel coronavirus IgM and IgG Antibodies in novel coronavirusin Infection”, the positive likelihood ratio of IgM and IgG antibody in diagnosis of COVID-19 (nucleic acid positive patients) was calculated, and the posterior probability of IgM and IgG antibodies and their tandem detection to diagnose was finally calculated.ResultsThe positive likelihood ratios of single IgM and IgG antibody were 18.50 and 12.65 respectively, and the posterior probabilities were 90.18% and 86.26% respectively. However, the posterior probability of the two antibodies tandem detection is 99.15%, which can give clinicians quantitative confidence in the diagnosis of COVID-19 from suspected cases. According to the results of this study, combining the advantages and disadvantages of nucleic acid detection and antibody detection, the clinical pathway for clinicians to diagnose COVID-19 is found.ConclusionFor suspected cases, IgM and IgG antibody tests should be firstly done at the same time. If the antibody tests are all positive, COVID-19 can be confirmed. If not, nucleic acid detection (one or more times) is performed, and in extreme cases, high-throughput viral genome sequencing is performed.

Author(s):  
Jin Zhang ◽  
Jianhua Liu ◽  
Na Li ◽  
Yong Liu ◽  
Rui Ye ◽  
...  

AbstractBackgroundPneumonia caused by 2019 novel coronavirus (2019-nCoV) was first reported in Wuhan, Hubei Province, China in December 2019. Then it has been reported in more than 20 countries and regions overseas rapidly. More than eighty thousand cases have been infected, resulting in more than three thousand deaths. Due to the limitation of nucleic acid detection, many clinical suspected cases cannot be diagnosed in time.MethodsWe used automated chemiluminescent immunoassay to detect serum IgM and IgG antibodies to 2019-nCoV of 736 subjects including confirmed Corona Virus Disease 2019 (COVID-19) patients, non-COVID-19 fever patients, other disease patients and medical staff as well as healthy people. The dynamic process of antibody production in COVID-19 disease progression were analyzed, and the value of antibody detection in the laboratory diagnosis of COVID-19 were evaluated.ResultsCOVID-19 patients were becoming reactive(positive) for specific anti-2019-nCoV IgM antibodies from 7-12 days after the onset of morbidity, followed closely by the IgG. The levels of specific IgM and IgG antibodies increased with the progression of the disease. The trend of IgM and IgG changes in different cases is not exactly the same. The levels of IgM and IgG and their distributions in different groups were different with that of healthy people. The areas under the ROC curves for IgM and IgG to diagnose COVID-19 were 0.988 and 1.000, respectively.ConclusionsSpecific IgM or IgG antibody detection had good sensitivity and specificity for the diagnosis of suspected fever cases. Detection of specific antibodies in patients with fever can be a good distinction between COVID-19 and other diseases in low epidemic area.


2020 ◽  
Vol 145 (1) ◽  
pp. 39-45
Author(s):  
Yaqing Li ◽  
Qiang He ◽  
Rizhen Yu ◽  
Hui Jiang ◽  
Weizhong Wang ◽  
...  

Context.— Covert severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections could be seeding new outbreaks. How to identify asymptomatic SARS-CoV-2 infections early has become a global focus. Objective.— To explore the roles of immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies detection, nucleic acid tests, and computed tomography (CT) scanning to identify asymptomatic SARS-CoV-2 infection. Design.— The clinical data of 389 individuals with close contacts, including in general characteristics, SARS-CoV-2 etiology, serum-specific IgM and IgG antibody detection and CT imaging results, were systematically analyzed. Results.— The present study showed that only 89 of 389 individuals with close contacts were positive after the first nucleic acid test, while 300 individuals were still negative after 2 nucleic acid tests. Among the 300 individuals, 75 did not have pneumonia, and the other 225 individuals had pulmonary imaging changes. A total of 143 individuals were eventually diagnosed as having asymptomatic infection through IgM antibody and IgG antibody detection. The sensitivity, specificity, and false-negative rate of IgM and IgG antibody detection were approximately 97.1% (347 of 357), 95.3% (204 of 214), and 4.67% (10 of 214), respectively. It also indicated that during approximately 2 weeks, most individuals were both IgM positive and IgG positive, accounting for 68.57% (72 of 105). During approximately 3 weeks, the proportion of IgM-positive and IgG-positive individuals decreased to 8.57% (9 of 105), and the proportion of IgM-negative and IgG-positive individuals increased to 76.19% (80 of 105). Conclusions.— There are highlighted prospects of IgM/IgG antibody detection as a preferred method in identifying the individuals with asymptomatic SARS-CoV-2 infection, especially combined with nucleic acid tests and pulmonary CT scanning.


1984 ◽  
Vol 93 (2) ◽  
pp. 205-212 ◽  
Author(s):  
G. E. D. Urquhart

SummaryA comparison of neutralizing and immunofluorescent (IF) IgG antibody tests in 18 sera from 10 cases of hand, foot and mouth disease (HFMD) showed a variety of responses but all sera taken more than one week after infection had both neutralizing and IF IgG antibodies.A survey of IF IgG antibody in 80 paediatric and 80 adult non-HFMD case sera gave antibody detection rates of 47·5% and 11·3% respectively. This difference could be attributed to a decline in IF IgG antibody with time after infection. Three point nine per cent of 2G sera from possible adult carditis cases had IF antibody suggesting that coxsackie A16 virus was not a common cause of adult carditis. Forty-eight point three per cent of 29 sera from cases of spontaneous abortion had detectable IF antibody, a rate similar to the paediatric sera and significantly greater than that in adult male (7·9%) and other adult female (13%) sera tested. This interesting observation requires further study.


2021 ◽  
Author(s):  
hong zhou

Abstract Background: The SARS-CoV-2 antibody detection are used to diagnose or exclude suspected COVID-19 patients as a supplement to nucleic acid detection. False-positive results of SARS-CoV-2 antibody have been reported but rarely associated with malaria. A case of malaria patient with SARS-CoV-2 antibody false-positive is described.Case presentation: A 24 year-old male returned from Côte d’Ivoire was diagnosed Plasmodium falciparum by Malaria rapid diagnostic test. The patient had suspicious exposure to COVID-19. His SARS-CoV-2 IgM antibody was positive one day before admission and turned negative on the 18th day of admission, while the IgG antibody and nasopharyngeal swabs SARS-Cov-2 nucleic acid had been negative. Conclusion: Malaria might cause false positive for SARS-CoV-2 IgM antibody. A careful interpretation of the SARS-CoV-2 antibody result is useful to avoid wasting medical resources especially malaria-endemic areas.


2021 ◽  
Vol 29 (1) ◽  
pp. 85-91
Author(s):  
Nan Jiang ◽  
Yaoyao Sun ◽  
Hongyan Sun ◽  
Bo Yang ◽  
Juan Tan ◽  
...  

Abstract Background: Coronavirus disease 2019 (COVID-19) has spread rapidly in China and globally. In order to control the spread of the epidemic, it is important to find an efficient diagnostic method. Objectives: The aim of this study was to assess the responses of antibodies during SARS-CoV-2 infection in relation to disease severity and to evaluate the association between the positive rate of antibody detection and nucleic acid test. Methods: Ninety patients with SARS-CoV-2 infection were recruited in this retrospective observational study. Demographic, clinical data, and SARS-CoV-2 IgM and IgG antibodies in serum specimens were detected at 4 and 6 weeks after diagnosis. Results: IgM and IgG antibody levels showed a decreased tendency, the titers at week 4 were higher than the titers at week 6: The positive rates of IgM at week 4 and 6 were 92.9% and 67.9%, respectively. The positive rates of IgG at week 4 and week 6 were 100%. No association was found between the positive rate of antibody detection at week 4 or 6 and that of nucleic acid test (P>0.05). No difference between the positive rate of antibodies against SARS-CoV-2 in severe and non-severe COVID-19 patients was observed. Conclusions: Antibody detection is an effective means in the diagnosis of COVID-19. The titer and positive rate of IgM are lower than those of IgG in the first six weeks after infection. Positive rate of antibodies was not different between severe and non-severe patients.


2020 ◽  
Author(s):  
chihai ji ◽  
Jingyu Wang ◽  
Yuchen Zeng ◽  
Haoming Pan ◽  
Yingfang Wei ◽  
...  

Abstract Background Pseudorabies, also known as Aujezsky’s disease, is an acute viral infection caused by pseudorabies virus (PRV). Swine are one of the natural hosts of pseudorabies, therefore, the disease brings huge economic losses to the swine industry. Establishment of a differential diagnosis technique that can distinguish between wild-type infected and vaccinated pigs, and monitor vaccine-induced IgG is crucial for eventual eradication of pseudorabies.Results The aim of this study was to develop a rapid dual detection method for PRV gE and gB protein IgG antibodies with high specificity and sensitivity. PRV gE codons at amino acid residues (aa) 52–238 and gB codons at aa 539–741 were expressed to obtain recombinant PRV gE and gB proteins by pMAL-c5x vector. After purification with Qiagen Ni–NTA agarose affinity, the two proteins were analyzed by SDS-PAGE and immunoblotting assay. Two single fluorescent-microsphere immunoassays (FMIA) were established by coupling two recombinant proteins (gE and gB) with two magnetic microbeads and an effective dual FMIA was developed by integrating the two single assays. Optimal serum dilution for each assay, correlation with other common swine virus-positive sera and comparison with ELISA for two PRV antigens were tested for validation. Compared with ELISA, the specificity and sensitivity were 99.26% and 92.3% for gE IgG antibody detection and 95.74% and 96.3% for gB IgG antibody detection by dual-FMIA.Conclusion We provide a new method for monitoring PRV protective antibody in vaccinated pigs and differentiating wild-type-PRV-infected from vaccinated pigs


2011 ◽  
Vol 18 (12) ◽  
pp. 2095-2101 ◽  
Author(s):  
Stuart D. Blacksell ◽  
Richard G. Jarman ◽  
Mark S. Bailey ◽  
Ampai Tanganuchitcharnchai ◽  
Kemajittra Jenjaroen ◽  
...  

ABSTRACTSix assays were evaluated in this study to determine their suitability for the diagnosis of acute dengue infection using samples from 259 Sri Lankan patients with acute fevers (99 confirmed dengue cases and 160 patients with other confirmed acute febrile illnesses): (i) the Merlin dengue fever IgG & IgM combo device (Merlin), (ii) the Standard Diagnostics Dengue Duo nonstructural 1 (NS1) antigen and IgG/IgM combo device (Standard Diagnostics, South Korea), (iii) the Biosynex Immunoquick dengue fever IgG and IgM (Biosynex, France) assay, (iv) the Bio-Rad NS1 antigen strip (Bio-Rad, France), (v) the Panbio Dengue Duo IgG/IgM Cassette (Inverness, Australia), and (vi) the Panbio dengue NS1 antigen strip (Inverness, Australia). The median number of days of fever prior to admission sample collection was 5 days (interquartile range, 3 to 7 days). Sensitivity and specificity of the NS1 antigen tests ranged from 49 to 59% and from 93 to 99%, respectively, and sensitivity and sensitivity of the IgM antibody test ranged from 71 to 80% and from 46 to 90%, respectively. Combining the NS1 antigen and IgM antibody results from the Standard Diagnostics Dengue Duo test gave the best compromise of sensitivity and specificity (93% and 89%, respectively) and provided the best sensitivity in patients presenting at different times after fever onset. The Merlin IgM/IgG antibody tests correctly classified 64% and 86% of the primary and secondary dengue infection cases, respectively, and the Standard Diagnostics IgM/IgG antibody tests correctly classified 71% and 83% of the primary and secondary dengue infection cases, respectively. This study provides strong evidence of the value of combining dengue antigen- and antibody-based test results in the rapid diagnostic test (RDT) format for the acute diagnosis of dengue.


Author(s):  
Xi Mo ◽  
Xueliang Wang ◽  
Zhaoqin Zhu ◽  
Yuetian Yu ◽  
Dong Chang ◽  
...  

COVID-19 continues to circulate globally in 2021, while under the precise policy implementation of China’s public health system, the epidemic was quickly controlled, and society and the economy have recovered. During the pandemic response, nucleic acid detection of SARS-CoV-2 has played an indispensable role in the first line of defence. In the cases of emergency operations or patients presenting at fever clinics, nucleic acid detection is required to be performed and reported quickly. Therefore, nucleic acid point-of-care testing (POCT) technology for SARS-CoV-2 identification has emerged, and has been widely carried out at all levels of medical institutions. SARS-CoV-2 POCT has served as a complementary test to conventional polymerase chain reaction (PCR) batch tests, thus forming an experimental diagnosis platform that not only guarantees medical safety but also improves quality services. However, in view of the complexity of molecular diagnosis and the biosafety requirements involved, pathogen nucleic acid POCT is different from traditional blood-based physical and chemical index detection. No guidelines currently exist for POCT quality management, and there have been inconsistencies documented in practical operation. Therefore, Shanghai Society of Molecular Diagnostics, Shanghai Society of Laboratory Medicine, Clinical Microbiology Division of Shanghai Society of Microbiology and Shanghai Center for Clinical Laboratory have cooperated with experts in laboratory medicine to generate the present expert consensus. Based on the current spectrum of major infectious diseases in China, the whole-process operation management of pathogen POCT, including its application scenarios, biosafety management, personnel qualification, performance verification, quality control, and result reporting, are described here. This expert consensus will aid in promoting the rational application and robust development of this technology in public health defence and hospital infection management.


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.


2018 ◽  
Vol 5 (2) ◽  
pp. 395
Author(s):  
Abhra Banerjee ◽  
Uttam Kumar Paul ◽  
Arup Bandyopadhyay

Background: Dengue fever is currently the most important arthropod borne viral disease. Since occurrence of dengue infections has been an epidemic in many parts of India and complications like DHF and DSS are increasing, while at the same time the diagnosis is challenging, particularly the laboratory diagnosis is confusing, this study was conducted to evaluate the different laboratory test methods and to compare their respective efficacy, timing, advantages and disadvantages.Methods: This study was done in the Department of Microbiology in collaboration with the Department of Medicine and Pediatrics in two tertiary care medical colleges and hospitals in eastern India. Blood samples from 319 patients with clinical features suggestive of Dengue fever were included in this study. Laboratory investigations were done which included immunological assays that were performed using commercially available kits - SD dengue duo NS1Ag + Ab combo rapid test, NS1 Ag capture ELISA, IgM capture ELISA, IgG capture ELISA test for dengue and other routine tests -full blood cell count, coagulation tests, routine biochemical and lipid profile were also done. Ethical considerations were taken care of and statistical evaluations were done.Results: An increased detection of IgM antibody (46.15%) was seen in the early febrile period (1-5 days) as compared to the mid-febrile period (6-10 days), and late febrile period (6-10 days) when it is 6.89%. IgG antibody is much less in early febrile period (4.16%). Compared to mid-febrile period (24.13%), and late febrile period (62.5%). IgM antibodies were detected in 44.5% of the samples, IgG antibodies were detected in 43.5% of the samples, Rapid test was positive in 36.9% and NS1AG ELISA was detected in 43.5% of the samples in the study.Conclusions: It can be inferred from our study that for detection of dengue in the early febrile period (1-5 days), estimation of dengue-specific serum IgM is the most sensitive antibody detection method.


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