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COVID-19 Serological Test

Ref. 800061-1

Rapid self test for the qualitative detection of IgG and IgM antibodies against SARS-CoV-2 in human blood specimens

COVID-19 Serological Test

POST-INFECTION ANTIBODIES

Serological tests detect the presence of antibodies (IgG and/or IgM targeting the Nucleocapsid protein) in blood produced by the body in response to an infection, such as SARS-CoV-2.

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Recent studies have shown that in people infected with the virus, IgM and/or IgG antibodies appear within 19 days after the onset of symptoms (in 60% of cases within the first week and in 90% within the second week).

WHO IS THIS TEST FOR?

COVID-19 SEROLOGICAL TEST is useful for anyone who wants to verify the antibody response following previous exposure to the virus.

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Serological tests can be useful for:
1) supporting the diagnosis in addition to molecular tests in cases of symptoms’ delay;
2) screening previous exposures;
3) surveying serum prevalence to define the levels of exposure of the population to the virus (particularly in asymptomatic people).

TECH SPECS

COVID-19 SEROLOGICAL TEST is a rapid immunochromatographic device for qualitative detection of IgG and IgM antibodies against SARS-CoV-2 Nucleocapsid protein in blood samples. This test indicates that the organism has been exposed to the virus, since specific antibodies targeting it are identified.

IgG Sensitivity 98.92%
IgM Sensitivity 92.98%
Specificity IgG + IgM 98.3%

CONTENT

  • 1 test cassette
  • 1 vial with dropper containing the diluent
  • 2 sterile lancets
  • 1 pipette for blood sampling
  • 1 cleanser gauze
  • instructions for use

USE PROCEDURE

  1. Draw a blood sample by using the sterile lancet provided;
  2. Collect the sample indicated with the black line by using the capillary pipette provided;
  3. Deposit the collected specimen into the sample well (S) indicated on the test cassette;
  4. Add 2 drops of the diluent and wait 10 minutes before reading the result.

RESULTS INTERPRETATION

Negative anti-Spike IgG levels are not present in the sample or they are present in very low concentrations, which are not detectable by the device.
Positive IgG and/or IgM antibodies have been detected in the blood sample. It is recommended to contact a specialist for further information.

BIBLIOGRAPHY

1. European Centre for Disease Prevention and Control, Disease background of COVID-19 (https://www.ecdc.europa.eu/en/2019-ncovbackground-disease)
2. https://www.who.int/emergencies/diseases/novel-coronavirus-2019
3. Valenti L et al. “SARS-CoV-2 seroprevalence trends in healthy blood donors during the COVID-19 Milan outbreak.” Submitted to Eurosurveillance, 2020, medRxiv preprint doi: https://www.medrxiv.org/content/10.1101/2020.05.11.2 0098442v2
4. Long, Q., Liu, B., Deng, H. et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med (2020)
5. FIND. Rapid Diagnostic Tests For Covid-19. https://www.finddx.org/wp-content/uploads/2020/05/FIND_COVID-19_RDTs_18.05.2020.pdf
6. Sethuraman N, Jeremiah SS, Ryo A. Interpreting Diagnostic Tests for SARSCoV2. JAMA. 2020;323(22):2249–2251. DOI:10.1001/jama.2020.8259

F.A.Q.

The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" section of the instructions for use.


A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample.


The color and intensity of the lines do not affect the interpretation of the result. The test has to be considered positive regardless of the color intensity of the test line (T).