Der COVID-19 IgM/IgG Rapid Test CE-IVD ist nur für den professionellen Gebrauch ausgelegt. Es erfolgt kein Verkauf an Privatpersonen!
Dieser Test dient als diagnostisches Hilfsmittel zur Feststellung einer fortgeschrittenen oder vergangenen Infektion mit dem Corona-Virus SARS-CoV-2.
Der Test ist nicht geeignet als Indikator für die Effizienz der Impfung.
Möchten Sie den Immunitätsstatus nach einer Impfung prüfen, benötigen Sie einen Test zum Nachweis neutralisierender Antikörper.
The COVID-19 IgM/IgG Rapid Test CE-IVD is for professional use only. There is no sale to private persons!
This test is intended as a diagnostic tool to detect advanced or past infection with Corona virus SARS-CoV-2.
The test is not suitable as an indicator of vaccination efficacy.
If you wish to check the immunity status after vaccination, you will need a test to detect neutralizing antibodies.
- Product Description:
- COVID-19 Human IgM IgG Rapid Test provides a fast, convenient, and qualitative testing of human whole blood, serum and plasma for COVID-19 (SARS-CoV-2) IgM and IgG.
- Suitable Sample:
- Human Venous Whole Blood (dipotassium EDTA, sodium heparin, sodium citrate), Serum, Plasma (dipotassium EDTA, sodium heparin, sodium citrate), and Finger Prick Whole Blood (dipotassium EDTA, tripotassium EDTA, no anticogulant)
- Fast result in 15 minutes
Easy to operate
Highly sensitive via visual inspection
20 Test Kit:
Testing Strips (20)
a. Colloidal Gold-Labeled COVID-19 Nucleocapsid (N) Protein
b. Colloidal Gold-Labeled COVID-19 Receptor-Binding Domain (RBD) Protein
c. Colloidal Gold-Labeled Chicken IgY Antibody with less than 0.1% Sodium Azide
d. Goat Anti-Human IgM Antibody
e. Goat Anti-Human IgG Antibody
f. Goat Anti-Chicken IgY Antibody with less than 0.1% Sodium Azide
Sample Buffers (20)
- Store product at 15-30°C and avoid direct exposure to sunlight.
Do not open until ready to use.
Do not freeze or store the product outside the temperature range described above.
Do not use after the expiration date.
Venous Whole Blood, Serum and Plasma Test Procedure
Finger Prick Whole Blood Test Procedure
- This product is a lateral flow chromatographic immunoassay for rapid, qualitative detection of human IgM and IgG antibodies against COVID-19 virus in human venous whole blood (dipotassium EDTA, sodium heparin, sodium citrate), serum, plasma (dipotassium EDTA, sodium heparin, sodium citrate), and finger prick whole blood (dipotassium EDTA, tripotassium EDTA, no anticogulant).
- GMP grade
- Clinical laboratories must include this information in their patient test report as specified in FDA guidance:
This test has not been reviewed by the FDA.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
Lateral Flow Immunoassay
- Result zone of the COVID-19 Testing Strip indicates human IgM line (M line), IgG line (G line) and control line (C line). C line must appear to ensure the quality of sample processing. Please refer to the diagram below for interpretation.
Lateral Flow Immunoassay
31 known COVID-19 positive and 75 known negative EDTA whole blood samples were collected, confirmed with EUA authorized RT-PCR, and tested for COVID-19 IgM and IgG reactivity following symptom onset with results read by two blinded, independent viewers.