Infectious Disease – BioMedomics Inc.

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.

BioMedomics CoV-SCAN Rapid Antigen Test demonstrated high sensitivity and specificity for numerous SARS-CoV-2 variants, including Omicron and Delta, in a peer-reviewed point-of-care clinical evaluation

BioMedomics CoV-SCAN Rapid Antigen Test demonstrated high sensitivity and specificity for numerous SARS-CoV-2 variants, including Omicron and Delta, in a peer-reviewed point-of-care clinical evaluation

Recently published in the highly regarded, peer-reviewed Journal of Clinical Virology Plus, a clinical point-of-care and laboratory trial, performed in conjunction with the Columbia University Irving Medical School, demonstrated the ability of the BioMedomics CoV-SCAN Rapid Antigen Test to detect SARS-CoV-2 variants with high sensitivity and specificity. These results are due to CoV-SCAN’s unique design, using 4 unique antibodies to detect SARS-CoV-2.

In laboratory testing, CoV-SCAN detected 14 variants, including Omicron and Delta, with similar sensitivity to the wild-type virus; CoV-SCAN did not cross-react with any other human coronaviruses.

In clinical point-of-care (POC) testing on 148 individuals over age 2 with symptom onset of less than or equal to 5 days, CoV-SCAN detected SARS-CoV-2 in 87.2% of COVID-19 infected individuals and did not misdiagnose any non-infected individuals. In another 884 asymptomatic individuals, CoV-SCAN detected 85.7% of COVID-19 infected individuals and correctly diagnosed 99.7% of non-infected individuals.

Importantly, CoV-SCAN detected SARS-CoV-2 in greater than 97.2% of patient specimens with CT values < 30, a well-established clinically meaningful cutoff for infectivity.

These results demonstrate that CoV-SCAN should detect SARS-CoV-2 variants, known and unknown, in almost all individuals harboring infectious quantities of COVID-19. Additionally, CoV-SCAN’s high specificity makes it incredibly useful for the early identification of new infectious clusters before they become hotspots.

To read the full article please click here

BioMedomics COVID-19 IgG/IgM Rapid Test highly effective in point of care (POC) use

The BioMedomics COVID-19 IgG/IgM Rapid Test is a rapid, point-of-care (POC) lateral flow immunoassay (LFA) that detects antibodies to the SARS-CoV-2 spike protein receptor-binding domain (RBD). It detects both early (IgM) and late (IgG) marker antibodies in human finger-prick capillary blood, venous whole blood, serum, and plasma. Since its launch in March 2020, it has gone through several independent validations and is being used globally in hospitals, clinics, and government agencies.

Widespread deployment of POC testing for SARS-CoV-2 could transform the global COVID-19 response, helping individuals quickly understand whether they were previously infected or have developed a robust response to vaccination, and informing health officials on the level of community protection that may be present.

As their use extends beyond traditional clinical settings to help determine serostatus after infection or vaccination, evaluating test performance against laboratory assays at the POC, not just in controlled laboratory settings, is essential.

A recent study provides insight into how SARS-CoV-2 lateral flow assays are likely to perform in POC settings when used by individuals other than laboratory professionals.

When used 1 month after the onset of symptoms, the demonstrated robust sensitivity (90%) and complete specificity (100%) in a heavily exposed household cohort.

To read the full article please click here

CoV-SCAN Antigen Test Kit

CoV-SCAN Rapid Antigen Test

BioMedomics has launched the CoV-SCAN Rapid Antigen Test (CoV-SCAN) to aid in the diagnosis of active coronavirus infection. The test detects the N-protein antigen of SARS-CoV-2 using a novel double antibody sandwich assay format. It uses a panel of antibodies, targeting multiple antigenic sites on SARS-CoV-2 N-protein antigen, that can detect many new variants of concern at equivalent (or up to eight-fold) improved sensitivity compared to original isolate.

To view our Instructions for Use, please click here.

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a novel beta coronavirus and is the causative agent of Coronavirus Disease 2019 (COVID-19) and the pandemic. SARS-CoV-2 is mainly transmitted through droplets and contact routes, and people who are infected with SARS-CoV-2 may express signs and symptoms of acute respiratory illness, such as fever, cough, shortness of breath, etc., but can also be asymptomatic.

In March of 2020, BioMedomics successfully created one of the most reliable, accurate, and fastest COVID-19 antibody tests in the world: the COVID-19 IgM/IgG Rapid Antibody Test. BioMedomics has continued to put their passion of developing fast, accurate, and reliable COVID-19 testing methods into the new CoV-SCAN Rapid Antigen Test. While PCR tests take days to reveal results and require complex and expensive equipment, antigen test enables early detection in an acute coronavirus infection, enabling healthcare providers to administer faster and accurate treatment methods. Knowledge of active infection in the fastest time possible is epidemiologically important and is crucial in controlling the spread and management of the COVID-19 pandemic

Features & Benefits

BioMedomics’s CoV-SCAN helps in detection of extracted nucleocapsid protein (N-protein) antigens specific to SARS-CoV-2 in nasal swab specimens directly collected from individuals who are suspected of COVID-19 by a healthcare provider within the first five (5) days of symptom onset.

Given the worldwide surge of variant infections, it is particularly significant that CoV-SCAN is able to detect SARS-CoV-2 variants that pose a threat to the resurgence of COVID-19 infections. Variants of concern detected include Alpha (B.1.1.7) and Delta (B.1.617.2, AY.2) and variants of interest detected include Iota (B.1.526) and Mu (B.1.621). It was observed that not only were all variants of concerns detected by CoV-SCAN, but all they were detected at equal or up to 8-fold better sensitivity than the original, isolate virus (WA1).

Sensitivity of CoV-SCAN to SARS- CoV-2 variants

* A lower concentration on swab represents a higher sensitivity of the test

Precise

Tests for active coronavirus infection
Quick & comfortable sample collection
Validated using PCR
Detects variants

Fast

Results in 15 minutes
Intuitive visual representative
No special equipment needed

How It Works

Nasal Collection

Steps

Collect nasal sample with the given sterile swab.
Vertically add 10 drops of lysis buffer into the sampling tube.
Rotate the swab against the inner tube wall about 10 times. Squeeze swab from outer tube wall to dissolve sample in solution.
Remove & discard swab and cover tube with dropper.
Place 3 drops of buffer in sample well. Read results after 15 minutes and no more than 20 minutes

Results

FAQs

What is the CoV-SCAN Test Kit?

CoV-SCAN is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein (N-protein) antigens specific to SARS-CoV-2 in nasal swab specimens directly collected from individuals who are suspected of COVID-19 by a healthcare provider within the first five (5) days of symptom onset.

How does the CoV-SCAN Test Kit work?

Nasal swab specimens require a sample preparation step (extraction) in which the sample is eluted into the lysis buffer solution. Extracted sample is added to the sample well of the test cassette to initiate the test. When the sample migrates in the test strip, SARS-CoV-2 viral antigens bind to anti-SARS-CoV-2 N-protein antibodies conjugated to indicator and capture particles in the test strip, forming an immune complex. The immune complex is then captured by the test line on the nitrocellulose membrane as it migrates through the strip.

Test results are interpreted at fifteen (15) minutes after sample addition. The presence of two (2) colored lines in the control line region (C-Line) and test line region (T-line) indicates the sample is SARS-CoV-2 positive. The presence of one (1) colored line, C-line, indicates the sample is SARS-CoV-2 negative. The absence of the C-line indicates an invalid test, and the sample must be retested.

How quickly can the CoV-SCAN Test Kit yield results?

Results are valid 15 minutes after sample and buffer are combined in the cassette sample well.

What do the results tell me?

A total of three detection lines are possible, with the control (C) line appearing when sample has flowed through the cassette.

1 | Invalid Result: If the quality control line (C) does not appear, then the test result is invalid and sample must be retested with a new cassette.

2 | Negative Result: If only the quality control line (C) appears and the detection T line is not visible, the sample does not contain novel coronavirus antigens or the antigen concentration is lower than the limit of detection and the result is negative.

3 | Positive Result: If both the quality control line (C) and the detection line T appears, then the novel coronavirus has been detected and the result is positive. Result should be determined by whether the T-line is colored or not regardless of the color intensity

What are the alternatives?

For best results, use a combination of the BioMedomics’s COVID-19 IgM/IgG Rapid Test to test for the detection of antibodies in human serum, plasma, or whole blood along with the CoV-SCAN Rapid Antigen Test for the detection of active infection. Combining the results of both a rapid COVID-19 Antigen and a rapid COVID-19 Antibody test, will give both the patient and healthcare provider the most accurate understanding of the patient’s health.

Product Comparison

RT-PCR Tests
Rapid Antigen Tests
Sensitivity
High
Moderate
Specificity
High
High
Test Complexity
Varies
Easy to use
Authorised for Use at POC
Mostly not
Yes
Turnaround Time
15 min to 36 hours
Approx 15 min
Intended Use
Detects current infection
Detects current infection
Analyte Detected
Viral RNA
Viral Antigens
Specimen Type(s)
Nasal Swab, Sputum, Saliva
Nasal Swab

NOTE: BioMedomics CoV-SCAN Antigen Test is not currently available for in vitro diagnostic use in the United States of America.

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BioMedomics, Inc. 1100 Perimeter Park Drive Suite 104 Morrisville, NC 27560 USA

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Brochure_LET_SARS-CoV-2 Antigen Test (LFIA)_EN

SARS-CoV-2 Antigen Test (LFIA) informational brochure, one page, English

SARS-CoV-2 Antigen Test Kit (LFIA)

BioMedomics has launched the SARS-CoV-2 Antigen Test Kit (LFIA) to aid in the diagnosis of an active coronavirus infection. The test detects the presence of the novel coronavirus antigens via nasal or nasopharyngeal secretion and provides diagnostic results within 15 minutes via a rapid lateral flow immunoassay (LFIA).

To view our Instructions for Use, please click here.

COVID-19 is a highly contagious and acute respiratory disease that has affected millions across the globe. Individuals infected by the novel coronavirus are the main source of infection, but asymptomatically infected individuals are also sources of incognito infection spreading. Based on the current epidemiological investigations, the incubation period of the virus is most commonly 3 to 7 days. The most common symptoms include fever, fatigue, and dry cough.

In March of 2020, BioMedomics successfully created one of the most reliable, accurate, and fastest COVID-19 antibody tests in the world: the COVID-19 IgM/IgG Rapid Antibody Test. BioMedomics has continued to put their passion of developing fast, accurate, and reliable COVID-19 testing methods into the new SARS-CoV-2 Antigen Test Kit (LFIA). While PCR tests take days to reveal results and require complex and expensive equipment, our antigen test enables early detection in an acute coronavirus infection, enabling healthcare providers to administer faster and more accurate treatment methods. Knowledge of active infection in the fastest time possible is epidemiologically important and is crucial in controlling the spread and management of the COVID-19 pandemic.