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 hp
Sign In
Advertise with Us
PURITAN MEDICAL

FUJIREBIO

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

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. More...

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
Fujirebio
Thermo Fisher Scientific


Gold Member
SARS-CoV-2 Reactive & Non-Reactive Controls
Qnostics SARS-CoV-2 Typing
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
Modular Hemostasis Automation Solution
CN Track
New
PlGF Test
Quidel Triage PlGF Test
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








DIASOURCE (A Biovendor Company)

Channels

Molecular Diagnostics

view channel
Image: The discovery of early markers for ovarian cancer that would have improved sensitivity could aid detection (Photo courtesy of Adobe Stock)

Highly Accurate Biomarkers Could Detect Ovarian Cancer Before Clinical Diagnosis

Ovarian cancer is a deadly and challenging disease, primarily because early detection is difficult. Most women (70-75%) are diagnosed only after the cancer has already spread, which significantly reduces... Read more

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: CellLENS enables the potential precision therapy strategies against specific immune cell populations in the tissue environment (Photo courtesy of MIT)

New AI System Uncovers Hidden Cell Subtypes to Advance Cancer Immunotherapy

To produce effective targeted therapies for cancer, scientists need to isolate the genetic and phenotypic characteristics of cancer cells, both within and across different tumors. These differences significantly... Read more

Technology

view channel
Image: The Check4 gene-detection platform (Photo courtesy of IdentifySensors)

Electronic Biosensors Used to Detect Pathogens Can Rapidly Detect Cancer Cells

A major challenge in healthcare is the early and affordable detection of serious diseases such as cancer. Early diagnosis remains difficult due to the complexity of identifying specific genetic markers... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.