SARS-CoV-2 IgM/IgG Detection Kit (Colloidal Gold-Based) [CE-IVD]
(CE Marking: NL-CA002-2020-50880)
SUPPLIED REAGENTS AND MATERIALS
- Test Chip: 50 Tests/Box
- Sample diluent buffer: 5ml/Bottle
- Graduated pipette: 50/Box
SARS-CoV-2 IgM/IgG detection kit is a lateral flow immunoassay which uses gold nanoparticles (AuNPs) as the colour marker for the detection and qualitative measurement of IgM and IgG antibodies against the nucleocapsid protein (NP) of SARS-CoV-2 virus in human blood.
The kit is only used as a supplementary test indicator for suspected cases with negative nucleic acid test results of SARS-CoV-2 virus, or used in conjugation with the nucleic acid test in diagnosis of suspected cases of coronavirus disease 19 (COVID-19). It cannot be used as a basis for diagnosis and exclusion of COVID-19, and it is not suitable for screening of general population.
The product is only applicable to medical institutions, and intended for use by professional person.
A positive test result requires further confirmation, and a negative test result cannot rule out the possibility of infection of SARS-CoV-2 virus.
The product is limited to clinical use and emergency storage during the COVID-19 outbreak, and cannot be used as a routine in vitro diagnostic reagent for clinical use. The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis based on the clinical manifestations of patients and other laboratory tests.
Laboratory testing of SARS-CoV-2 virus shall be carried out in accordance with local requirements for biosafety.
In December 2019, a novel coronavirus, now officially named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been identified in Wuhan China, which caused the outbreak of a coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19), Signs and symptoms of COVID-19 may occur 2 to 14 days after infection, which include fever, cough, shortness of breath or difficulties in breathing, pain in the muscle and tiredness. In severe cases, the infection can further lead to pneumonia, severe acute respiratory syndrome (SARS), kidney failure and death.
Nucleocapsid protein (NP) is the most abundant protein on the helical nucleocapsid of coronaviruses, which envelopes the entire genomic RNA. NP also interacts with other viral structural proteins to play important roles during host cell entry and virus particle assembly and release. Anti-NP antibodies have been shown to be the earliest and the most predominant antibodies detectable in patient’s blood samples after coronavirus infection.
SARS-CoV-2 IgM/IgG detection kit is based on the principle of an immunochromatography in vitro test for the qualitative determination of antibodies against SARS-CoV-2 NP protein. When the sample is added to sample pad, it moves to the conjugate pad and resuspends NP-conjugated gold nanoparticles (AuNPs) that are dried on the conjugate pad. NP-conjugated AuNPs bind to anti-NP antibodies in the specimen and form an antibody-NP-AuNPs complex. The mixture moves along the nitrocelluose membrane by capillary action and reacts with anti-human IgM as well as anti-human IgG antibodies that have been immobilized in the test reaction area separately. If antibody against SARS-CoV-2 is present enough in the sample, a coloured band in the test reaction area is appeared. If there is no antibody against SARS-CoV-2 or not sufficient in the sample, the area will remain colourless. The sample continues to move to the control reaction area, and forms a red or purple colour, indicating the test is working properly and the result is valid.
STORAGE AND PREPARATION OF TEST SAMPLES
- Full blood samples are suggested to be assayed immediately after collection.
- Serum or plasma samples are suggested to be assayed immediately after separation, or preferably stored frozen (-200C or below) for less than 1 month in aliquots. Multiple freeze-thaw cycles should be avoided. Specimens are suggested to be balance to room temperature (180C -280C) before detection.
- When required, vortex test serum or plasma samples at room temperature to ensure homogeneity. Then centrifuge samples at 10,000 to 15,000 rpm for 5 minutes prior to assay to remove particulates. Please do not omit this centrifugation step if samples are cloudy and containing particles.
- Serum or plasma specimens with EDTA, sodium citrate or heparin can be tested.
- Hemolytic specimens as well as specimens with visible microbial contamination should not be used. Highly Lipaemic or icteric specimens are not recommended.
STORAGE AND STABILITY
- The detection kit is stable until the expiry date when stored at 2-8°C. The detection kit can be kept at 4-30°C a few days for shipping.
- The Test Chip is stable until the expiry date only when stored at 4-30°C in sealed foil pouches. The expiry date is stated on the foil pouch and kit container.
- Do not remove the Test Chip from the pouch until ready to use. The Test Chip should be used immediately once opened.
- For long time storage, the sample diluent buffer should be stored at 2-8°C. It is stable until the expiry date before opening, and is stable for 28 days after opening.
- Once removed from refrigerator, allow the sample diluent buffer for 30 minutes to return to room temperature before testing.
- If the whole kit is stored in a refrigerator, allow a minimum of 30 minutes for the Test Chip and sample diluent buffer to reach room temperature while it is in the sealed pouch.