We do have Covid19 IgG/IgM Immunoassay rapid tests to fight the pandemic
0

Your Cart is Empty

MA1919

Covid19 IgG/IgM Antibody Rapid POC Test CE-marked

Rapid, cassette test immunoassay for the differential detection of IgM & IgG antibodies to the COVID-19 virus (Coronavirus) with CE certification available for all countries outside of the United States. Orders of 5000-100,000 preferred.

  • Antibody-capture immunochromatographic assay
  • Can be used with serum, plasma, or whole blood samples
  • Results ready in 15 minutes

THE PROBLEM

O n March 11, 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. There were approximately 130,000 total cases worldwide at the time. Since then, the number of COVID-19 cases worldwide has risen exponentially, now approaching 10 million. Low- and middle-income countries are struggling to roll out the necessary testing to address the virus. Many developing countries do not have the medical infrastructure or the financial resources to do the widespread molecular diagnostic testing seen in wealthier countries, which requires specialized swabs, chemicals, lab equipment, and trained personnel.

THE SOLUTION

Over the course of three weeks, Maternova researched over 75 tests for COVID-19 and is now distributing the lowest cost and highest sensitivity/specificity combination antibody test. 

While PCR is the gold standard (using a nasal swab to test for the actual genetic material of the virus), these PCR tests are often slower to run and need machinery and specialized staff.  Our COVID-19 IgG/IgM antibody tests return results within 15 minutes (and in as little as one minute if strongly positive). 

The COVID-19 rapid tests that we are manufacturing are cassette antibody-capture immunoassays, meaning that they detect the antibodies to the COVID-19 pathogen.  It is very important that the immunoassays used be developed using SARS-CoV-2 specific proteins. 

To administer the test, a serum, plasma, or whole blood sample is pipetted into the sample well of the testing device along with an assay buffer. The test works by detecting COVID-19 IgM and/or IgG antibodies in the sample as it flows through the assay by first COVID-19 virus-specific antigens conjugated with colloidal gold that attach to the COVID-19-specific antibodies and provide a “visual tag” for the complex and second, by two separate test lines - one with immobilized monoclonal anti-human IgM and one with immobilized monoclonal anti-human IgG - that capture the relevant COVID-19-specific antibody. When a test line becomes concentrated with antibodies, the concentrated visual tag produces a visible colored band that is confirmation of the presence of the target molecule (COVID-19 IgM or IgG antibodies). The presence of a colored band/pink line for either or both COVID-19 IgM and IgG antibodies indicates a positive result for possible COVID-19 infection. Results are ready in 15 minutes.

Accuracy

The analysis of sensitivity and specificity are as follows for the immunoassay we distribute:

      Sensitivity: 93.4%

      Specificity: 97.7%

Use Case

There are several use cases for a rapid point of care immunoassay, even while maintaining PCR as the gold standard test where available.  As noted by the global diagnostics experts at FIND:

"Although most SARS-CoV-2 testing for diagnosis and confirmation today is performed in central laboratories, we need to continue the effort to provide POC systems with sufficient performance for local confirmation and diagnostic testing far more quickly. Triage testing could be based upon combined clinical presentation and basic clinical test patterns (e.g. CBC and metabolic tests) for COVID-19 versus other respiratory diseases, and should be thoroughly investigated as one option to provide far greater availability and lower cost than current testing, which can be followed with more complex and expensive confirmation tests like RNA assays."

The tests utilize whole blood or serum.

Included in orders

  • Rapid test cartridge
  • Buffer to add to the whole blood or serum sample
  • Capillary tube to collect sample 
  • Instructions for use

Not included in orders

  • Gloves
  • Lancet 

Please contact us at info@maternova.net with "COVID-19 Urgent" in the heading.

More Literature on Antibodies and COVID-19

"The data presented in this study provide evidence that SARS-CoV-2 infection follows a similar antibody pattern and time course to other viral infections. It also implies that serological testing, in conjunction with other methods of detection, can provide a robust method of diagnosing COVID-19 across early and late stages of infection. Of the types of antibodies measured, total antibody metrics were the most sensitive in detecting SARS-CoV-2 versus IgM or IgG alone.

The strong positive correlation between antibody titer levels after two weeks of symptom onset and clinical severity is also noteworthy. High titers of SARS-CoV-2 total antibodies could be an important risk factor for critical illness, distinct from the previously established risk factors of age, gender, and underlying conditions."  (Text is taken from a longer article by Assay Genie)


““Although antibody tests do not detect a high percentage of infected people until 10 to 14 days after infection, you must remember that it takes time for symptoms to appear and then for people in developing countries to get to a health clinic and get access to a diagnostic test,” said Gary Weil, MD, a professor of medicine and of molecular microbiology at Washington University School of Medicine in St. Louis. “By the time someone actually gets tested, they may have been symptomatic for more than a week, and most people do have detectable antibodies at that point. Rapid antibody tests for COVID could work really well in low-resource settings because they require only a finger stick of blood, and results are available within minutes. With that information in hand, public health authorities could isolate infected people or transfer them to a more advanced medical facility, test their families and start contact tracing. It could be really helpful for controlling this disease in countries with limited resources, even though it’s imperfect.”” (from WashU School of Medicine)

Rapid, cassette test immunoassay for the differential detection of IgM & IgG antibodies to the COVID-19 virus (Coronavirus) with CE certification available for all countries outside of the United States. Orders of 5000-100,000 preferred.

  • Antibody-capture immunochromatographic assay
  • Can be used with serum, plasma, or whole blood samples
  • Results ready in 15 minutes

THE PROBLEM

O n March 11, 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. There were approximately 130,000 total cases worldwide at the time. Since then, the number of COVID-19 cases worldwide has risen exponentially, now approaching 10 million. Low- and middle-income countries are struggling to roll out the necessary testing to address the virus. Many developing countries do not have the medical infrastructure or the financial resources to do the widespread molecular diagnostic testing seen in wealthier countries, which requires specialized swabs, chemicals, lab equipment, and trained personnel.

THE SOLUTION

Over the course of three weeks, Maternova researched over 75 tests for COVID-19 and is now distributing the lowest cost and highest sensitivity/specificity combination antibody test. 

While PCR is the gold standard (using a nasal swab to test for the actual genetic material of the virus), these PCR tests are often slower to run and need machinery and specialized staff.  Our COVID-19 IgG/IgM antibody tests return results within 15 minutes (and in as little as one minute if strongly positive). 

The COVID-19 rapid tests that we are manufacturing are cassette antibody-capture immunoassays, meaning that they detect the antibodies to the COVID-19 pathogen.  It is very important that the immunoassays used be developed using SARS-CoV-2 specific proteins. 

To administer the test, a serum, plasma, or whole blood sample is pipetted into the sample well of the testing device along with an assay buffer. The test works by detecting COVID-19 IgM and/or IgG antibodies in the sample as it flows through the assay by first COVID-19 virus-specific antigens conjugated with colloidal gold that attach to the COVID-19-specific antibodies and provide a “visual tag” for the complex and second, by two separate test lines - one with immobilized monoclonal anti-human IgM and one with immobilized monoclonal anti-human IgG - that capture the relevant COVID-19-specific antibody. When a test line becomes concentrated with antibodies, the concentrated visual tag produces a visible colored band that is confirmation of the presence of the target molecule (COVID-19 IgM or IgG antibodies). The presence of a colored band/pink line for either or both COVID-19 IgM and IgG antibodies indicates a positive result for possible COVID-19 infection. Results are ready in 15 minutes.

Accuracy

The analysis of sensitivity and specificity are as follows for the immunoassay we distribute:

      Sensitivity: 93.4%

      Specificity: 97.7%

Use Case

There are several use cases for a rapid point of care immunoassay, even while maintaining PCR as the gold standard test where available.  As noted by the global diagnostics experts at FIND:

"Although most SARS-CoV-2 testing for diagnosis and confirmation today is performed in central laboratories, we need to continue the effort to provide POC systems with sufficient performance for local confirmation and diagnostic testing far more quickly. Triage testing could be based upon combined clinical presentation and basic clinical test patterns (e.g. CBC and metabolic tests) for COVID-19 versus other respiratory diseases, and should be thoroughly investigated as one option to provide far greater availability and lower cost than current testing, which can be followed with more complex and expensive confirmation tests like RNA assays."

The tests utilize whole blood or serum.

Included in orders

  • Rapid test cartridge
  • Buffer to add to the whole blood or serum sample
  • Capillary tube to collect sample 
  • Instructions for use

Not included in orders

  • Gloves
  • Lancet 

Please contact us at info@maternova.net with "COVID-19 Urgent" in the heading.

More Literature on Antibodies and COVID-19

"The data presented in this study provide evidence that SARS-CoV-2 infection follows a similar antibody pattern and time course to other viral infections. It also implies that serological testing, in conjunction with other methods of detection, can provide a robust method of diagnosing COVID-19 across early and late stages of infection. Of the types of antibodies measured, total antibody metrics were the most sensitive in detecting SARS-CoV-2 versus IgM or IgG alone.

The strong positive correlation between antibody titer levels after two weeks of symptom onset and clinical severity is also noteworthy. High titers of SARS-CoV-2 total antibodies could be an important risk factor for critical illness, distinct from the previously established risk factors of age, gender, and underlying conditions."  (Text is taken from a longer article by Assay Genie)


““Although antibody tests do not detect a high percentage of infected people until 10 to 14 days after infection, you must remember that it takes time for symptoms to appear and then for people in developing countries to get to a health clinic and get access to a diagnostic test,” said Gary Weil, MD, a professor of medicine and of molecular microbiology at Washington University School of Medicine in St. Louis. “By the time someone actually gets tested, they may have been symptomatic for more than a week, and most people do have detectable antibodies at that point. Rapid antibody tests for COVID could work really well in low-resource settings because they require only a finger stick of blood, and results are available within minutes. With that information in hand, public health authorities could isolate infected people or transfer them to a more advanced medical facility, test their families and start contact tracing. It could be really helpful for controlling this disease in countries with limited resources, even though it’s imperfect.”” (from WashU School of Medicine)

News & Updates

Sign up to get the latest on sales, new releases and more …

maternal and newborn health news