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.

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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

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.

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.

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

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

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.

Find Out More

Contact Info

ADDRESS

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

CALL US

919.890.3070

E-MAIL

info@biomedomics.com

SARS-CoV-2 Antigen Test Kit (LFIA)

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.

Features & Benefits

BioMedomics’s SARS-CoV-2 Antigen Test (LFIA) is used to qualitatively detect antigens of the novel coronavirus via nasal or nasopharyngeal secretion collection.

Precise

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

Fast

  • Results in 15 minutes
  • Intuitive visual representative
  • No special equipment needed

How It Works

Nasal Collection

Nasopharyngeal Collection

Steps

1. Collect nasal or nasopharyngeal secreation sample with the given sterile swab.

2. Vertically add 10 drops of lysis buffer into the sampling tube.

3. Rotate the swab against the inner tube wall about 10 times. Squeeze swab from outer tube wall to dissolve sample in solution.

4. Remove & discard swab and cover tube with dropper.

5. Place 3 drops of buffer in sample well. Read results after 15 minutes and no more than 20 minutes.

Results

FAQs

The COVID-19 Antigen Test (LFIA) is an antigen test used to aid in the diagnosis of an active coronavirus infection via a lateral flow immunoassay (LFIA). The test detects the presence of the novel coronavirus antigens via nasal or nasopharyngeal secretion and provides diagnostic results within 15 minutes.

The test cassette contains (1) colloidal gold-labeled anti-SARS-CoV-2 antibody and quality control antibody colloidal gold marker, (2) one detection line (T line) and one quality control line(C) fixed on a nitrocellulose membrane. T is fixed with anti-SARS-CoV-2 antibody for detecting the novel coronavirus. The quality control antibody is fixed on the C line. When the appropriate amount of test sample treated with lysis buffer is added to the sample well of the test cassette, the sample will move forward along the test strip via capillary action. If the sample contains the novel coronavirus antigens and concentration of antigens is higher than the limit of detection, the antigen will bind to the colloidal gold-labeled anti-SARS-CoV-2 antibody. The immune complex will be captured by the anti-SARS-CoV-2 antibody immobilized on the membrane, forming a red T line and indicating a positive result for the novel coronavirus. If the sample contains no novel coronavirus antigens or the antigens concentration is lower than the limit of detection, a negative result is displayed.

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

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 contains no novel coronavirus antigens or the antigens 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.

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 SARS-CoV-2 Antigen Test Kit (LFIA) for the detection of active infection. By combining the results of both a rapid COVID-19 Antigen and a rapid COVID-19 Antibody test, it will give both the patient and healthcare provider the most accurate understanding of the patient’s health.

Product Comparison

NOTE: BioMedomics SARS-CoV-2 Antigen Test Kit (LFIA) is not currently available for in vitro diagnostic use in the USA.

Find Out More

Contact Info

ADDRESS

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

CALL US

919.890.3070

E-MAIL

info@biomedomics.com

Instructions_COVID19_ES

BioMedomics COVID-19 IgM-IgG Rapid Test Instructions For Use insert for CE Marked Kits, A4, Spanish

Instructions_COVID19_PT

BioMedomics COVID-19 IgM-IgG Rapid Test Instructions For Use insert for CE Marked Kits, A4, Portuguese

Instructions_COVID19_DE

BioMedomics COVID-19 IgM-IgG Rapid Test Instructions For Use insert for CE Marked Kits, A4, German

Instructions_COVID19_EN

BioMedomics COVID-19 IgM-IgG Rapid Test Instructions For Use insert for CE Marked Kits, A4, English

COVID-19 IgM/IgG Rapid Test

COVID-19 IgM/IgG Rapid Test

BioMedomics has developed and launched one of the world’s best rapid point-of-care lateral flow immunoassays to aid in the diagnosis of coronavirus infection. The test detects both early marker and late marker, IgM/IgG antibodies in human finger-prick (capillary) or venous whole blood, serum, and plasma samples. The COVID-19 IgM/IgG Rapid Test by BioMedomics, Inc. demonstrates a combined sensitivity and specificity of 100% and ~99% respectively, making it one of the most accurate and reliable tests in the world.

There is a critical, global need for serology assays that can complement nucleic acid (PCR) tests for diagnosing COVID-19 infection.  Although critically important, PCR tests are only positive during the brief window of acute infection, after which they become negative. And while serology tests are not as effective as PCR early in acute infection, they are able to detect COVID-19 antibodies for a prolonged period of time after disease resolution, which enables identification of prior infection. Knowledge of prior infection is epidemiologically important and represents a significant unmet need in the management of the COVID-19 pandemic.

Features & Benefits

BioMedomics Rapid IgM-IgG Combined Antibody Test for COVID-19 is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.

Precise

  • Works with whole blood, serum, & plasma
  • Tests for both IgM and IgG antibodies
  •  Validated using PCR

Fast

  • 10-15 minutes per test
  • Intuitive visual interpretation
  • No special equipment needed

How It Works

COVID-19_4 steps

Steps

1. Collect blood/serum/plasma sample.

2. Add blood/serum/plasma sample to sample well.

3. Place 2-3 drops of buffer in sample well.

4. Read results after 10 minutes and no more than 15 minutes.

Results

FAQs

BioMedomics Rapid IgM-IgG Combined Antibody Test for COVID-19 is a lateral flow immunoassay used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro. 

This test should not be used with heat inactivated or other inactivated human specimen (blood, serum, plasma). Fresh samples should be collected and tested immediately.

The test strip contains a colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, two detection lines (G and M lines) and one quality control line (C) fixed on a nitrocellulose membrane. M is fixed with monoclonal anti-human IgM antibody for detecting the novel coronavirus IgM antibody. G is fixed with monoclonal antihuman IgG antibody for detecting the novel coronavirus IgG antibody. The quality control antibody is fixed on the C line.

Results are valid 10 minutes after sample and buffer are combined in the cassette sample well. 

The BioMedomics COVID-19 IgM-IgG Rapid Test was tested using clinical samples at Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu CDC), Nanjing, China. The COVID-19 IgM-IgG Rapid Test is intended to test IgM and IgG separately. The test was validated against a panel of previously frozen samples consisting of twenty six (26) SARS-CoV-2 antibodies (both IgM and IgG) positive and eighty (80) antibody-negative plasma samples. The antibody-positive samples were collected from clinically-confirmed COVID-19 infected patients and the presence of anti-SARS-Cov-2 antibodies were confirmed with a chemiluminescent IgM and IgG assay (magnetic particles). Within the 26 positive samples, 22 samples tested positive for both IgM and IgG antibodies by BioMedomics COVID-19 IgM-IgG Rapid Test, 4 samples tested positive for only IgG. All 80 negative specimens were collected from healthy donors and confirmed SARS-CoV-2 antibody negative with both the COVID-19 IgM-IgG Rapid Test and the chemiluminescent IgM and IgG assay. Testing was performed using one lot of the COVID-19 IgM-IgG Rapid Test. Confidence intervals for sensitivity and specificity were calculated per a score method described in CLSI EP12-A2 (2008). The results and data analysis are shown in the tables below.

The BioMedomics COVID-19 IgM-IgG Rapid Test displayed a combined sensitivity of 100% (95% CI:86.77%-100%) and a combined specificity of 98.75% (95% CI:93.23%-99.97%).

A total of three detection lines are possible, with the control (C) line appearing when sample has been flowed through the cassette.
1 | Negative Result: If only the quality control line (C) appears and the detection lines G and M are not visible, then no novel coronavirus antibody has been detected and the result is negative.
2 | Positive Result, M only: If both the quality control line (C) and the detection line M appears, then the novel coronavirus IgM antibody has been detected and the result is positive for the IgM antibody.
3 | Positive Result, G only: If both the quality control line (C) and the detection line G appears, then the novel coronavirus IgG antibody has been detected and the result is positive for the IgG antibody.
4 | Positive Result, G and M: If the quality control line (C) and both detection lines G and M appear, then the novel coronavirus IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies.

The COVID-19 IgM/IgG Rapid Test can be used to screen patients suspected of having been affected by the novel coronavirus. However, results of  test should not be the only basis for diagnosis. Results should be used in combination with clinical observations and other testing methods such as nucleic acid PCR test.

Product Comparison

NOTE: BioMedomics COVID-19 IgM-IgG Combined Antibody Rapid Test is not currently available for in vitro diagnostic use in the USA.

Find Out More

Contact Info

ADDRESS

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

CALL US

919.890.3070

E-MAIL

info@biomedomics.com