Journal of Virological Methods

Mitigation of the ongoing COVID-19 pandemic requires reliable and accessible laboratory diagnostic services. We evaluated the performance of one LDT and two commercial tests, cobas(R) SARS-CoV-2 (Roche) and Amplidiag(R) COVID-19 (Mobidiag), for the detection of SARS-CoV-2 RNA in respiratory specimens. 183 specimens collected from suspected COVID-19 patients were studied with all three methods to compare their performance. In relation to the reference standard, which was established as the result...

Hemoglobin (Hb) disorders are among the most common monogenic diseases affecting nearly 7% of the worlds population. Among various Hb disorders, approximately 1.5% of the world population carry {beta}-thalassemia ({beta}-Thal), affecting 40,000 newborns every year. Early screening and timely diagnosis are essential in {beta}-thalassemia patients for prevention and management of later clinical complications. However, in Africa to Southern Europe, Middle East, and Southeast Asia, where {beta}-thal...

AbstarctO_ST_ABSBackgroundC_ST_ABSThe COVID-19 serological tests for IgG and IgM have been developed with several methodologies: Immunoenzymatic Assay (ELISA), Chemiluminescence, Electro Chemiluminescence, Fluorescent Lateral Flow Immunoassays and Immunochromatography. None of these tests should be used for the diagnosis or population screening of the disease, considering that the antibodies appear only on the 8th - 14th day of the disease onset. The present study evaluates a sample of immunoflu...

Public health emergency of SARS-CoV-2 has facilitated diagnostic testing as a related medical countermeasure against COVID-19 outbreak. Numerous serologic antibody tests have become available through an expedited federal emergency use only process. This paper highlights the analytical characteristic of an ELISA based assay by AnshLabs and three random access immunoassay (RAIA) by DiaSorin, Roche, and Abbott that have been approved for emergency use authorization (EUA), at a tertiary academic cen...

The rapid spread of SARS-CoV-2 coronavirus infection has led to the development of molecular and serologic tests in a short period of time. While tests such as RT-PCR have applications in the immediate diagnosis revealing the presence of the virus, serological tests can be used to determine previous exposure to the virus and complement acute diagnosis. Antibody production can occur as early as 5 days post-infection. Both IgM and IgG specific anti-SARS-COV-2 antibodies can be a useful tool to tes...

IntroductionSARS-CoV2 serology testing is multipurpose provided to choose an efficient test. We evaluated and compared 4 different commercial serology tests, three of them had the Food and Drug Administration (FDA) approval. Our goal was to provide new data to help to guide the interpretation and the choice of the serological tests. MethodsFour commercial tests were evaluated: Cobas(R)Roche(R)(total anti-N antibodies), VIDAS(R)Biomerieux(R)(IgM and IgG anti-RBD antibodies), Mindray(R)(IgM and I...

BACKGROUNDThe outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly spread globally. The laboratory diagnosis of SARS-CoV-2 infection has relied on nucleic acid tests. However, there are many limitations of nucleic acid tests, including low throughput and high rates of false negatives. More sensitive and accurate tests to effectively identify infected patients are needed. METHODSThis study has developed fully automated chemiluminescent immunoassays (CLIA) to deter...

IntroductionSerological detection of antibodies against SARS-CoV-2 has become an essential tool to test vaccine efficacy and epidemiological surveillance of COVID-19. There have been limited published studies documenting the performance of SARS-CoV-2 antibody assays within hispanic populations. Materials and methodsWe evaluated the diagnostic performance of a chemiluminescence enzyme immunoassay (CLIA) on a set of 1,035 samples including pre-pandemic samples, healthcare workers (HCW), blood don...

There are many available rapid antibody tests, but the performance of such tests remains unclear. Moreover, it is difficult to compare among the various devices regarding their sensitivity & specificity. In order to compare the performance of such devices, we used Cohen kappa statistics to assess the level of agreement between RT-PCR and rapid antibody tests. In doing this study, we considered the term of validity after symptom-onset to compare two tests. It takes more than a week to produce an...

Present pandemic scenario, there exists an unmet global need for the development of a rapid and sensitive method for the detection of SARS-CoV-2 infection. The available options for identification of SARS-CoV-2 infection are detection of viral RNA by qRT-PCR, Antigen or Antibody testing by serological methods. Even though many kits available commercially but none of them are rapid, sensitive and high throughput. OnCovid total antibody assay is a diagnostic method developed by us uses the princi...

BackgroundThis study was aimed to investigate the application of SARS- COV-2 IgM and IgG antibodies in diagnosis of COVID-19 infection. MethodThis study enrolled a total of 178 patients at Huangshi Central Hospital from January to February, 2020. Among them, 68 patients were SARS-COV-2 infected confirmed with nucleic acid test (NAT) and CT imaging. 9 patients were in the suspected group (NAT negative) with fever and other respiratory symptoms. 101 patients were in the control group with other d...

IntroductionAntibodies to the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can increase as soon as 10-13 days after infection. We describe our evaluation of the Abbott SARS-CoV-2 IgG assay on the Architect immunoassay analyser. MethodsWe assessed the precision, sensitivity, and specificity of the Abbott SARS-CoV-2 IgG assay in samples from polymerase chain reaction (PCR) positive patients and healthy healthcare workers. The manufacturer cut-off index (COI) of 1.4 was adopt...

Effective clinical and public health decision-making during a pandemic depends on reliable and interoperable clinical diagnostic test results. To ensure trustworthy outcomes, we need widely available and harmonized calibration standards on a shared scale. We present a playbook for an inter-laboratory harmonization study that calibrates any available standards against a limited-availability standard issued by a global authority like the World Health Organization (WHO).

As SARS-CoV-2 and its variants continue to spread, a reliable and convenient alternative to nasopharyngeal swabbing and RT-PCR testing is needed. To test the usability and performance of saliva sample collection, saliva, nasal and nasopharyngeal swab specimens were collected from a total of 338 individuals consisting of confirmed COVID-19 patients and healthy subjects. To evaluate the diagnostic accuracy of self-collected and performed SARS-CoV-2 rapid antigen test on saliva and nasal swabs spec...

In this study, we aimed to evaluate the stability of SARS-CoV-2 under four different heat conditions (37, 42, 56, 60 {degrees}C) and report that the virus is stable at 37 {degrees}C for at least 24 hours. Heating at 56 {degrees}C for 30 minutes, however, effectively inactivated the virus while preserved the stability of viral RNA in both human sera and sputum samples. These findings provide critical information regarding the biology of the virus as well as a practical way to inactivate infectiou...

Background: In the context of the COVID-19 pandemic, numerous new serological test systems for the detection of anti-SARS-CoV-2 antibodies have become available quickly. However, the clinical performance of many of them is still insufficiently described. Therefore we compared three commercial, CE-marked, SARS-CoV-2 antibody assays side by side. Methods: We included a total of 1,154 specimens from pre-COVID-19 times and 65 samples from COVID-19 patients ([≥]14 days after symptom onset) to e...

The recent emergence of SARS-CoV-2 lead to a current pandemic of unprecedented levels. Though diagnostic tests are fundamental to the ability to detect and respond, many health systems are already experiencing shortages of reagents associated with this test. Here, testing a pooling approach for the standard RT-qPCR test, we find that a single positive sample can be detected even in pools of up to 32 samples, with an estimated false negative rate of 10%. Detection of positive samples diluted in e...

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 antibodie...

Due to urgency and demand, numerous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoassays are rapidly being developed and placed on the market with limited validation on clinical samples. Thorough validation of serological tests are required to facilitate their use in the accurate diagnosis of SARS-CoV-2 infection, confirmation of molecular results, contact tracing, and epidemiological studies. This study evaluated the sensitivity and specificity of nine commercially availabl...

BackgroundSerology tests for detecting the antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can identify previous infection and help to confirm the presence of current infection. ObjectiveThe aim of this study was to evaluate the performances of a newly developed high throughput immunoassay for anti-SARS-CoV-2 IgG antibody detection. ResultsClinical agreement studies were performed in 77 COVID-19 patient serum samples and 226 negative donor serum/plasma samples. Posit...