BioMedomics receives Health Canada authorization for its CoV-SCAN Rapid Antigen Test

Morrisville, NC, USA – BioMedomics, a renowned player in the medical diagnostics field, has recently received authorization from Health Canada’s Medical Device Directorate to import and distribute its CoV-SCAN Rapid Antigen Test and the COVID-19 Antigen External Control Kit. This significant achievement underscores the accuracy and reliability of BioMedomics’ test kit in detecting the presence of COVID-19.

The CoV-SCAN Rapid Antigen Test is a result of collaboration between BioMedomics and a major academic medical institution in the United States. The kit employs a panel of antibodies that allows it to detect various variant viruses, including Omicron and its many subtypes, from human specimens. BioMedomics’ test kit stands out from existing approved rapid antigen tests due to its incorporation of novel antibody technologies licensed from a world-leading group on COVID-19 at a major US academic institution. Specifically, the kit uses multidomain antibodies, which originally derived from human COVID-19 patients’ antibody selections, and is uniquely designed to detect all existing COVID variants and any future emerging variants.

In a clinical trial, the CoV-SCAN demonstrated a sensitivity of 95% in specimens with CT values less than or equal to 30 and a specificity of 100%. Furthermore, the test detected most specimens with CT values greater than 30, with an average value of 35.3. The CoV-SCAN is designed for professional use and can be used with anterior nasal swab specimens collected from individuals who are symptomatic within five days of symptoms, ages 2 years and older. The kit provides results in just 15 minutes. The COVID-19 Antigen External Control Kit, designed specifically for the CoV-SCAN, is available for purchase separately from BioMedomics.

“We are thrilled to have received Health Canada’s authorization for the CoV-SCAN Rapid Antigen Test and the COVID-19 Antigen External Control Kit,” said Dr. Frank Wang, CEO of BioMedomics. “This approval is a testament to the hard work and dedication of our team working with our great partner in developing a reliable and accurate test kit that can be used by healthcare professionals in the fight against COVID-19.”

The CoV-SCAN Rapid Antigen Test is now available for use in Canada through authorized channels. To purchase the kit or obtain more information about it, visit the BioMedomics website and contact the company’s sales team.

Sickle SCAN Rapid Test Featured in New Book on Tropical Medicine Innovations

Publisher Wiley-Blackwell released a new book in May entitled “Revolutionizing Tropical Medicine: Point-of-Care Tests, New Imaging Technologies and Digital Health” by authors/editors Kerry Atkinson and David Mabey. Written for physicians, infectious disease specialists, pathologists, radiologists, nurses, pharmacists and other health care workers, as well as government healthcare managers, the book is an essential and realistic guide to treating and diagnosing patients in low-resource tropical countries based on new technologies.

Chapter 14, written by doctors Amina Nardo-Marino and Tom N. Williams, is entitled Rapid Diagnostic Tests for the Detection of Sickling Hemoglobin. The authors discuss traditional point-of-care screening methods as well as some newer innovations, including Sickle SCAN. From the authors:

The most promising test, however, is a lateral flow immunoassay device marketed as Sickle SCAN. The Sickle SCAN device is a rapid, qualitative lateral flow immunoassay kit that can be used to diagnose the most common forms of SCD (HbSS and HbSC), as well as sickle cell trait (HbAS), using a capillary blood sample.

The book is available now, and more information can be found at the Wiley Online Library at: https://onlinelibrary.wiley.com/doi/book/10.1002/9781119282686

BioMedomics Sickle SCAN Rapid Test Evaluated Under Real-World Conditions in Africa: the DREPATEST Study

A study published this month in the journal BMC Hematology, evaluated the performance of BioMedomics’ Sickle SCAN rapid test under real-world environmental conditions in two West African countries.

From the published paper:

“Previous to the DREPATEST study, Sickle SCAN had been assessed in field conditions in two studies in sub-Saharan Africa, with promising results. However, none of these studies provided information regarding the climate conditions. The aim of this study is to assess the diagnostic accuracy (sensitivity and specificity) of the Sickle SCAN POC test and its acceptability to persons conducting the tests under field conditions (temperature and relative humidity) in children older than 6 months of age and adults, in Lome (Togo) and Bamako (Mali), West Africa.”

“We conclude that the Sickle SCAN® test demonstrates excellent to perfect (HbAS, HbAC, HbSS, HbSC)or perfect (HbCC and HbAA) diagnostic accuracy, under both laboratory and field conditions. This rapid test demonstrates outstanding sensitivity and specificity when evaluated against existing gold standards. In addition, this test allows instrument- and electricity-free visual diagnostics, and requires minimal training to be performed.This rapid test is cheaper, easier to implement,and logistically more convenient than the current standard diagnostic methods in use in West Africa.”

The entire study can be viewed and downloaded here:

https://doi.org/10.1186/s12878-018-0120-5