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
LGC Clinical Diagnostics


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

Platinum Supplier
SARS-CoV-2 Reactive & Non-Reactive Controls
Qnostics SARS-CoV-2 Typing
Gold Supplier
SARS-CoV-2 Test
One Step SARS-CoV-2 Nucleic Acid Detection Kit (P761H)
Trichomonas Vaginalis Diagnostic Test
Aptima Trichomonas Vaginalis Assay
Testicular Germ Cell Tumors Test

Print article


Clinical Chemistry

view channel
Image: The new assays are designed to run on the B•R•A•H•M•S KRYPTOR compact PLUS clinical chemistry analyzer (Photo courtesy of Thermo Fisher)

Breakthrough Immunoassays to Aid in Risk Assessment of Preeclampsia

Preeclampsia is a life-threatening blood pressure condition that can arise during pregnancy and the postpartum phase. This severe pregnancy complication is a primary cause of maternal and fetal mortality... Read more

Molecular Diagnostics

view channel
Image: The ClarityDX Prostate test can reduce unnecessary prostate biopsies by up to 35% (Photo courtesy of Nanostics)

Innovative Blood Test to Revolutionize Prostate Cancer Detection and Reduce Invasive Biopsies

One in six men will receive a prostate cancer diagnosis during their lives. Thankfully, if caught early, prostate cancer is highly treatable. However, the existing screening process has its limitations.... Read more


view channel
Image: The latest FDA clearance has finally brought HemoScreen to its full potential as a true POC hematology analyzer (Photo courtesy of PixCell)

True POC Hematology Analyzer with Direct Capillary Sampling Enhances Ease-of-Use and Testing Throughput

An innovative 5-part differential Complete Blood Count (CBC) analyzer with direct capillary sampling capability significantly simplifies blood sampling and minimizes the pre-analytical process.... Read more


view channel
Image: A new test could detect the body’s adaptive immune response to viruses (Photo courtesy of 123RF)

Predictive T-Cell Test Detects Immune Response to Viruses Even Before Antibodies Form

The adaptive immune system is an incredible defense mechanism that allows the human body to identify and mount targeted responses against specific pathogens. T-Cells, a special kind of white blood cell,... Read more


view channel
Image: On-chip pretreatment and rapid AST based directly on positive blood cultures (Photo courtesy of Liu Yang)

Integrated Solution for Rapid AST Directly From Positive Blood Cultures to Combat Bloodstream Infection

The presence of living bacteria in the bloodstream, known as bacteremia, can lead to serious conditions like bloodstream infections (BSIs) and sepsis, which can often be fatal. Quickly prescribing the... Read more


view channel
Image: The Mitotic Counting algorithm was trained on over 100,000 individual mitosis and across seven scanner models (Photo courtesy of Gestalt Diagnostics)

New AI Algorithm for Use on Eight Types of Cancer Trained on Seven Scanner Models

A new artificial intelligence (AI) algorithm for use on one of the broadest trained environments is now available for commercial or research work. Gestalt Diagnostics (Spokane, WA, USA) has released the... Read more


view channel
Image: A new electrochemical device can quickly and inexpensively identify people at greatest risk for osteoporosis (Photo courtesy of ACS Central Science, 2023)

Electrochemical Device Identifies People at Higher Risk for Osteoporosis Using Single Blood Drop

With the global increase in life expectancy, the incidence of age-related conditions like osteoporosis is increasing. Osteoporosis, affecting around 200 million individuals worldwide, has a higher incidence... Read more


view channel
Image: AACC Middle East is a two-day conference that brings the latest in laboratory medicine to the Middle East region (Photo courtesy of ADLM)

AACC Middle East 2023 to Explore Latest Trends in Clinical Pathology and Laboratory Medicine

The AACC Middle East Conference and Exposition will be held by the Association for Diagnostics & Laboratory Medicine (ADLM - formerly AACC, Washington, DC, USA) in partnership with Life Dx (Abu Dhabi,... Read more
Copyright © 2000-2023 Globetech Media. All rights reserved.