VIDAS® SARS-COV-2 IgM & VIDAS® SARS-COV-2 IgG 

Automated qualitative assays for the detection of antibodies specific to the SARS-CoV-2 virus.

  • High sensitivity (PPA*) and specificity (NPA**)
  • Separate IgM & IgG results in 27 minutes 
  • Easy onboarding on all VIDAS instruments
  • For in vitro diagnostic use under the Emergency Use Authorization (EUA) only

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*Positive Percent Agreement

**Negative Percent Agreement 

WHAT IS COVID-19?

Near the end of 2019, a new virus was identified in China.1 It spread rapidly and was reported to cause severe pneumonia in adults. The virus, a new member of the coronavirus family capable of infecting humans, was named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The disease the virus causes is referred to as COVID-19, which stands for Corona Virus Disease 2019.

SARS-CoV-2 is transmitted via respiratory droplets and may also aerosolize, becoming airborne.2 The virus can cause a wide range of symptoms, but it is most frequently associated with upper respiratory symptoms and fever.3 In most patients, the disease resolves without causing severe illness. However, in 10-15% of cases4 and particularly in patients with existing co-morbidities and risk factors, the disease can be severe, requiring hospitalization and supportive care. Severe illness can impair lung function and other organs including but not limited to kidneys, heart, and blood vessels.5 Such impairment requires intensive care and can lead to patient death. Because of its complex presentation, novelty, and transmissibility, COVID-19 is the subject of ongoing scientific and medical study.

WHAT ARE SOME OF THE CHALLENGES ASSOCIATED WITH TRANSMISSION OF THE SARS-COV-2 VIRUS?

An important issue regarding COVID-19 is that people may be infected by SARS-CoV-2 but remain asymptomatic, meaning that they feel mostly or completely normal. However, people who are asymptomatic may still shed viruses that are capable of infecting other individuals.7 The absence of protective measures such as wearing masks and maintaining a safe distance makes disease transmission more likely.8

HOW DOES THE IMMUNE SYSTEM PRODUCE ANTIBODIES AGAINST SARS-COV-2?

Following SARS-CoV-2 infection, the immune system produces three classes of antibodies.6 First are immunoglobulin A (IgA) and immunoglobulin M (IgM), which can typically be detected in blood a few days after infection. Immunoglobulin G (IgG) follows a few days after that. IgM is not present in the blood for as long as IgG, because IgG is more efficient in fighting against the virus. This means that serologic antibody tests may not detect IgM after a certain amount of time has passed, which is why it is important to test for both IgM and IgG antibodies.

HOW CAN SEROLOGY TESTING HELP COMBAT COVID-19?

Widespread testing for the virus and for antibodies may help us understand how the virus circulates within populations, including among asymptomatic individuals.9 The two forms of testing available—direct testing for the virus using molecular techniques and serologic testing for antibodies—both provide different types of helpful information.10

Most people infected by SARS-CoV-2 develop specific IgM and IgG antibodies as a key component of their immune response to fight against the infection. The presence of such antibodies in the blood shows that an individual has encountered the virus and met it with an immune response.

When performed soon after the onset of symptoms, IgM and IgG testing may offer information about the evolution of the SARS-CoV-2 infection because of the transient nature of IgM and the duration of IgG in the bloodstream. This information is of particular interest because it may indicate a patient’s risk of expelling viral particles.

At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. However, while serologic testing has limitations, doctors can use the information as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent infection. Additionally, widespread serology testing or testing in targeted exposed populations such as healthcare workers or community workers can provide an assessment of prior exposure to the virus.11 Lastly, information about disease spread can help drive public health policy decisions related to infection control.10

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  1. Boni MF, Lemey P, Jiang X, et al. Evolutionary origins of the SARS-CoV-2 sarbecovirus lineage responsible for the COVID-19 pandemic. Nat Microbiol (2020). DOI:10.1038/s41564-020-0771-4 (link the DOI number to http://doi.org/10.1038/s41564-020-0771-4)
  2. Klompas M, Baker MA, Rhee C. Airborne transmission of SARS-CoV-2: theoretical considerations and available evidence. JAMA. 2020;324(5):441-442.  DOI: 10.1001/jama.2020.12458. (link DOI number to http://doi.org/10.1001/jama.2020.12458)
  3. Michelen M, Jones N, Stavropoulou C. In patients of COVID-19, what are the symptoms and clinical features of mild and moderate cases? Center for Evidence-Based Medicine (CEBM), University of Oxford. Available at: www.cebm.net/covid-19/in-patients-of-covid-19-what-are-the-symptoms-and-.... Published April 1, 2020. Accessed August 4, 2020. (make link active)
  4. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72,314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020;323(13):1239–1242. DOI:10.1001/jama.2020.2648. (link DOI number to http://doi.org/10.1001/jama.2020.2648)
  5. Gupta A, Madhavan MV, Sehgal K, et al. Extrapulmonary manifestations of COVID-19. Nat Med. 2020;26:1017–1032. DOI:10.1038/s41591-020-0968-3. (link DOI number to http://doi.org/10.1038/s41591-020-0968-3)
  6. Di Mauro G, Scavone C, Rafaniello C, Rossi F, Capuano A. SARS-Cov-2 infection: response of human immune system and possible implications for the rapid test and treatment. Int Immunopharmacol. 2020;84:106519. DOI: 10.1016/j.intimp.2020.106519. (link DOI number to https://doi.org/10.1016/j.intimp.2020.106519)
  7. Gandhi M, Yokoe DS, Havlir DV. Asymptomatic transmission, the Achilles’ heel of current strategies to control COVID-19. N Enl J Med. 2020;382(22):2158-2160. DOI: 10.1056/nejme2009758. (link DOI number to http://doi.org/10.1056/nejme2009758
  8. Chu DK, Akl EA, Duda S, et al. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. Lancet. 2020;395(10242):1973-1987. DOI: 10.1016/S0140-6736(20)31142-9. (link DOI number to http://doi.org/10.1016/S0140-6736(20)31142-9)
  9. Havers FP, Reed C, Lim T, et al. Seroprevalence of antibodies to SARS-CoV-2 in 10 sites in the United States, March 23-May 12, 2020. JAMA Intern Med. Published online July 21, 2020. Accessed August 4, 2020. DOI: 10.1001/jamainternmed.2020.4130. (link DOI number to http://doi.org/10.1001/jamainternmed.2020.4130)
  10. La Marca A, Capuzzo M, Paglia T, Roli L, Trenti T, Nelson SM. Testing for SARS-CoV-2 (COVID-19): a systematic review and clinical guide to molecular and serological in-vitro diagnostic assays. Reprod Biomed Online. 2020;S1472-6483(20)30318-7. DOI: 10.1016/j.rbmo.2020.06.001. (link DOI number to http://doi.org/10.1016/j.rbmo.2020.06.001)
  11. Garcia-Basteiro AL, Moncunill G, Tortajada M, et al. Seroprevalence of antibodies against SARS-CoV-2 among health care workers in a large Spanish reference hospital. Nat Commun 11, 3500 (2020). DOI: 10.1038/s41467-020-17318-x (link DOI number to http://doi.org/10.1038/s41467-020-17318-x)

 

References

  1. Boni MF, Lemey P, Jiang X, et al. Evolutionary origins of the SARS-CoV-2 sarbecovirus lineage responsible for the COVID-19 pandemic. Nat Microbiol (2020). DOI:10.1038/s41564-020-0771-4 
  2. Klompas M, Baker MA, Rhee C. Airborne transmission of SARS-CoV-2: theoretical considerations and available evidence. JAMA. 2020;324(5):441-442. DOI: 10.1001/jama.2020.12458
  3. Michelen M, Jones N, Stavropoulou C. In patients of COVID-19, what are the symptoms and clinical features of mild and moderate cases? Center for Evidence-Based Medicine (CEBM), University of Oxford. Available at: www.cebm.net/covid-19/in-patients-of-covid-19-what-are-the-symptoms-and-clinical-features-of-mild-and-moderate-case/. Published April 1, 2020. Accessed August 4, 2020. 
  4. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72,314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020;323(13):1239–1242. DOI:10.1001/jama.2020.2648
  5. Gupta A, Madhavan MV, Sehgal K, et al. Extrapulmonary manifestations of COVID-19. Nat Med. 2020;26:1017–1032. DOI:10.1038/s41591-020-0968-3
  6. Di Mauro G, Scavone C, Rafaniello C, Rossi F, Capuano A. SARS-Cov-2 infection: response of human immune system and possible implications for the rapid test and treatment. Int Immunopharmacol. 2020;84:106519. DOI: 10.1016/j.intimp.2020.106519.
  7. Gandhi M, Yokoe DS, Havlir DV. Asymptomatic transmission, the Achilles’ heel of current strategies to control COVID-19. N Enl J Med. 2020;382(22):2158-2160. DOI: 10.1056/nejme2009758
  8. Chu DK, Akl EA, Duda S, et al. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. Lancet. 2020;395(10242):1973-1987. DOI: 10.1016/S0140-6736(20)31142-9
  9. Havers FP, Reed C, Lim T, et al. Seroprevalence of antibodies to SARS-CoV-2 in 10 sites in the United States, March 23-May 12, 2020. JAMA Intern Med. Published online July 21, 2020. Accessed August 4, 2020. DOI: 10.1001/jamainternmed.2020.4130
  10. La Marca A, Capuzzo M, Paglia T, Roli L, Trenti T, Nelson SM. Testing for SARS-CoV-2 (COVID-19): a systematic review and clinical guide to molecular and serological in-vitro diagnostic assays. Reprod Biomed Online. 2020;S1472-6483(20)30318-7. DOI: 10.1016/j.rbmo.2020.06.001
  11. Garcia-Basteiro AL, Moncunill G, Tortajada M, et al. Seroprevalence of antibodies against SARS-CoV-2 among health care workers in a large Spanish reference hospital. Nat Commun 11, 3500 (2020). DOI: 10.1038/s41467-020-17318-x

 

VIDAS SARS-COV-2 lgM & VIDAS SARS-COV-2 lgG

Results You Can Trust When Facing A Novel Virus

VIDAS offers a flexible and easy way to rapidly detect IgM & IgG antibodies of individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

VIDAS SARS-COV-2

  • Detects the presence of antibodies by using the S1/receptor-binding domain (RBD) of the SARS- CoV-2 S protein
  • Reliable results in 27 minutes
  • Two tests with the same protocol to differentiate lgM & lgG results
  • Provides index value and no equivocal zone

The VIDAS Advantage

  • Ideal for either individual or batch testing
  • Ready-to-use reagents with calibration materials included in kits
  • Available on all VIDAS platforms (MINI VIDAS, VIDAS, VIDAS 3)
  • Minimal maintenance and easy to use

COVID-19 Comprehensive Solutions

True to our commitment to serving public health worldwide, bioMérieux offers a comprehensive in vitro diagnostic solution for COVID-19, aimed to support testing and surveillance, faster treatment decisions, prevention of transmission, and antimicrobial stewardship. Click here to learn more.


 

  • These tests have not been FDA cleared or approved;
  • These tests have been authorized by the FDA under an EUA for use by authorized laboratories;
  • These tests have been authorized only for the detection of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and,
  • These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Technical Details

Product Information

  VIDAS SARS-COV-2 IgM VIDAS SARS-COV-2 IgG
 
Reference Number 423833-01 423834-01
Tests / Kit 60
Results Qualitative
Time to Results 27 Minutes (Compatible with Lyme Protocol)
Sample Volume 100 µL
Sample Type Serum or Plasma (Lithium Heparin)
Calibration Frequency 28 Days

Performance

SENSITIVITY (PPA*)

Days from Onset of Symptoms

≤ D7

D8-D14

≥ D15

IgM 36.8% 82.4% 100%
IgG 36.8% 84.2% 100%
SPECIFICITY (NPA**)
IgM 99.4%
IgG 99.9%

To access more resources and strengthen your expertise, visit the technical library.

*Positive Percent Agreement
**Negative Percent Agreement

Resources

DOWNLOAD OUR FLYER

 

SARS-COV-2 Serology Guidelines

Resource Year Page / Publication
Centers for Disease Control and Prevention (CDC) 2020

Interim Guidelines for COVID-19 Antibody Testing.
https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html

National Institute of Health (NIH) 2020 Testing for SARS-CoV-2 Infection. https://www.covid19treatmentguidelines.nih.gov/overview/sars-cov-2-testing/

 

PRN 056308 Rev01.A

VIDAS SARS-COV-2 IgG

DATE OF EUA ISSUANCE

FACT SHEETS & LABELING

EUA DETERMINATION AND DECLARATION     

August 6, 2020

Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Coronavirus (COVID-19)

VIDAS SARS-COV-2 IgM

DATE OF EUA ISSUANCE

FACT SHEETS & LABELING

EUA DETERMINATION AND DECLARATION     

August 6, 2020

Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Coronavirus (COVID-19)

 

Pioneering Diagnostics