We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
Octopus Group


Fujirebio is a global leader in the field of IVD testing with more than 50 years’ experience in the conception, devel... read more Featured Products: More products

Download Mobile App

Novel SARS CoV-2 Rapid Antigen Test Validated for Diagnostic Accuracy

By LabMedica International staff writers
Posted on 01 Nov 2022
Print article
Image: The ESPLINE SARS-CoV-2 is for in vitro diagnostic (IVD) use with immunochromatographic assay for the detection of SARS-CoV-2 antigen directly from nasopharyngeal swab fluid and is intended for use as an aid in the diagnosis of SARS-CoV-2 infection (Photo courtesy of Fujirebio)
Image: The ESPLINE SARS-CoV-2 is for in vitro diagnostic (IVD) use with immunochromatographic assay for the detection of SARS-CoV-2 antigen directly from nasopharyngeal swab fluid and is intended for use as an aid in the diagnosis of SARS-CoV-2 infection (Photo courtesy of Fujirebio)

Many health care providers are hopeful regarding COVID-19 testing programs that use accurate rapid antigen tests to reduce the burden on the health care system through early diagnosis of infection. Currently, various antigen-detecting rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2 are commercially available.

The widespread use of testing outside medical institutions suggests that anterior nasal specimens, which can be safely self-collected by the patient, are now being used instead of nasopharyngeal specimens collected by medical staff. Therefore, to evaluate the usefulness of specimens collected from the anterior nasal cavity, understanding the viral load and diagnostic accuracy of tests performed using anterior nasal specimens is vital.

Pediatricians at the Jichi Medical University (Tochigi, Japan) and their colleagues conducted a prospective cross-sectional study from February 12, 2021 to September 30, 2021. They enrolled 16 patients (age range, <1 month-76 years) and samples were collected simultaneously from anterior nasal and nasopharyngeal sites continuously during hospitalization. The primary end points were the diagnostic accuracy of the Ag-RDT and utility of anterior nasal specimens.

The scientists determined the diagnostic performance of the RapidTesta SARS-CoV-2 test (Sekisui Medical Co., Ltd., Tokyo, Japan) and compare it with that of RT-PCR, using specimens collected from the anterior nasal and nasopharyngeal sites. Furthermore, ESPLINE SARS-CoV-2 (Fujirebio Co., Ltd., Tokyo, Japan), an Ag-RDT that has been marketed and widely used since May 2020, was used as a comparator representing the efficacy of common Ag-RDTs.

Four specimen swabs were taken simultaneously from each patient on admission: an anterior nasal and nasopharyngeal specimen from each nostril and also repeat samples. To judge the RapidTesta SARS-CoV-2 results objectively, the team evaluated the results using the RapidTesta Reader after visual assessment. RNA extraction was performed using the QIAamp Viral RNA Mini Kit (Qiagen, Hilden, Germany) with a 140-µL aliquot of each sample. A one-step RT-PCR (Thermo Fisher Scientific, Waltham, MA, USA) was performed which targets nucleotide 2 gene-specific primers for SARS-CoV-2.

The investigators reported that in total 226 sets of paired samples were obtained. In 88.2% of specimens, the viral load was high at the nasopharyngeal site. The mean cycle threshold values for the anterior nasal and nasopharyngeal sites were 32.4 and 29.9, respectively. Using the real-time polymerase chain reaction results as a reference, the Ag-RDT showed a 100% sensitivity up to day 6 of the illness, using specimens with moderate or high viral load (cycle threshold <30) from either site. From day 7, the sensitivity was 70.4% - 90.6% and 83.9% - 84.6% for the anterior nasal and nasopharyngeal sites, respectively. The specificity remained at 100%.

The authors concluded that they had demonstrated the diagnostic accuracy of the newly developed RapidTesta SARS-CoV-2 test for the accurate diagnosis of COVID-19 in terms of both sensitivity and specificity. The anterior nasal cavity was shown to be useful as a specimen collection site. The study was published on November 1, 2022 in the International Journal of Infectious Diseases.

Related Links:
Jichi Medical University
Sekisui Medical Co., Ltd
Thermo Fisher Scientific

Gold Supplier
COVID-19, Flu A/B Multiplex RT-PCRTest
TaqPath COVID-19, FluA, FluB Combo Kit
Lipase Assay
Lipase Assay
Gold Supplier
Virus Detection System
Thyroid Stimulating Hormone Test
TSH Rapid Test

Print article


Clinical Chem.

view channel
Image: Brief schematic diagram of the detection principle and method (Photo courtesy of CAS)

Rapid, Non-Invasive Method Diagnoses Type 2 Diabetes by Sniffing Urinary Acetone

Over 90% of diabetes cases are attributed to Type 2 diabetes (T2D), a prevalent metabolic condition that is expected to impact 380 million individuals globally by 2025. Despite being highly accurate, the... Read more

Molecular Diagnostics

view channel
Image: Researchers have identified the origin of subset of autoantibodies that worsen lupus (Photo courtesy of Pexels)

Lupus Biomarker Testing Could Help Identify Patients That Need Early and Aggressive Treatment

Systemic lupus erythematosus (SLE) is an autoimmune disease that occurs when the body's antibodies, which usually protect against infections, attack healthy cells and proteins. These autoantibodies can... Read more


view channel
Image: A genetic test could guide the use of cancer chemotherapy (Photo courtesy of Pexels)

Genetic Test Predicts Whether Bowel Cancer Patients Can Benefit From Chemotherapy

Late-stage bowel cancer patients usually undergo a series of chemotherapies and targeted medicines for cancer treatment. However, the responses to the last-line chemotherapy treatment trifluridine/tipiracil... Read more


view channel
Image: Use of DBS samples can break barriers in hepatitis C diagnosis and treatment for populations at risk (Photo courtesy of Pexels)

DBS-Based Assay Effective in Hepatitis C Diagnosis and Treatment for At Risk Populations

In a bid to eliminate viral hepatitis as a public health threat by 2030, the World Health Organization (WHO) has put forth a proposed strategy. To this end, researchers at the Germans Trias i Pujol Research... Read more


view channel
Image: New research has opened a path for fast and accurate cancer diagnosis (Photo courtesy of Imagene)

AI-Based Image Analysis Software Profiles Cancer Biomarkers in Real Time

Lung cancer is the most widespread type of cancer worldwide, resulting in approximately 1.76 million fatalities annually. Non-small cell lung cancer (NSCLC) accounts for 85% of all lung cancer diagnoses... Read more


view channel
Image: Live view of non-fluorescent specimens using the glowscope frame (Photo courtesy of Winona State University)

Device Converts Smartphone into Fluorescence Microscope for Just USD 50

Fluorescence microscopes are utilized to examine specimens labeled with fluorescent stains or expressing fluorescent proteins, like those tagged with green fluorescent protein. However, since these microscopes... Read more


view channel
Image: The global antimicrobial resistance diagnostics market size is expected to reach USD 5.7 billion by 2028 (Photo courtesy of Pexels)

Global Antimicrobial Resistance Diagnostics Market Driven by Increasing Hospital-Acquired Infections

Antimicrobial drugs are intended to counteract the harmful effects of microbes and promote a healthy life. However, their excessive use can result in the development of resistance, commonly referred to... Read more
Copyright © 2000-2023 Globetech Media. All rights reserved.