This product is NOT for home use. This product intended for trained professionals.
Contact Us for Special Pricing Options.
FOR THE QUALITATIVE ASSESSMENT OF IgG AND IgM ANTIBODIES TO 2019 NOVEL CORONAVIRUS IN HUMAN SERUM, PLASMA OR WHOLE BLOOD
For In Vitro Diagnostic Use Only
QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood.QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.
Coronavirus Disease 2019 (COVID-19) is an acute infectious disease caused by the 2019 novel coronavirus (SARS-CoV-2). The incubation period of the disease is 1-14 days, usually 3-7 days. The incubation period is infectious. Asymptomatic carriers may also be sources of infection. Respiratory droplets and contact are the main routes of transmission. The initial symptoms of the patients are fever, fatigue and cough, and gradually developed dyspnea and other serious manifestations. Most of the patients have a good prognosis, but some of the severe cases may have acute respiratory distress syndrome, septic shock, or even death. At present, there is no specific treatment for the disease.
There are several days of incubation period after being infected by 2019-nCoV. IgM antibodies can be detected soon after incubation period and remain for a short time. IgM positive blood samples can indicate acute infection. IgG antibodies appear after a few days of incubation period and remain for a long time. IgG positive blood samples can indicate current or previous infection.
QuickProfile™ 2019-nCoV IgG/IgM Combo Test Card utilizes the principle of Immunochromatography. Mouse anti-human IgM and human IgG antibodies are immobilized on the nitrocellulose membrane as two individual test lines (IgM line and IgG line) in the test window of the test device. The IgM line in the test window is closer to the sample well than the IgG line. As the test sample flows through the membrane within the test device, the colored–2019-nCoV antigen-colloidal gold conjugate forms complex with specific antibodies (IgM and/or IgG) of the 2019 novel coronavirus, if present in the sample. This complex moves further on the membrane to the test region where it is captured by the anti-human IgM and/or human IgG antibodies coated on the membrane, leading to formation of a colored band, which indicates a positive test result. Absence of this colored band in the test window indicates a negative test result. A built-in control line will always appear in the test window when the test has performed properly, regardless of the presence or absence of anti-2019 novel coronavirus antibodies in the specimen.
1. QuickProfile™ 2019-nCoV IgG/IgM Test Card
2. Sample buffer
3. 2 μL capillary pipet
4. Instructions for Use
MATERIALS REQUIRED BUT NOT SUPPLIED
Clock or timer, safety lancets, alcohol prep-pad, specimen collection container, centrifuge, biohazard waste container.disposable gloves, disinfectant.
1. Store the test device at 4 to 30oC in the original sealed pouch. Do Not Freeze.
2. The expiration date indicated on the pouch was based on these storage conditions.
3. The test device should remain in its original sealed pouch until ready for use. After opening, the test device should be used immediately. Do not reuse the device.
1. For professional in vitro diagnostic use only.
2. Do not use the product beyond the expiration date.
3. Do not use the product if the pouch is damaged or the seal is broken.
4. Handle all specimens as potentially infectious.
5. Follow standard laboratory procedure and biosafety guidelines for the handling and disposal of potentially infectious material. When the assay procedure is completed, dispose specimens after autoclaving at 121º C for at least 20 min or treating with 0.5% Sodium Hypochlorite for 1-2 hours.
SPECIMEN COLLECTION AND PREPARATION
1. The serum, plasma or whole blood specimen should be collected under standard laboratory conditions.
2. Heat inactivation of specimens, which may cause hemolysis and protein denaturation, should be avoided.
3. The test works best on fresh whole blood / serum / plasma samples. If testing cannot be performed immediately, serum / plasma may be stored at 2-8ºC up to 3 days in case of delay in testing. For long-term storage, serum / plasma specimens can be frozen at -20ºC for 3 months or -70ºC for longer period. Repeated freezing and thawing of the specimen should be avoided.
4. Sodium azide can be added as a preservative up to 0.1% without affecting the test results.
1. The control band is an internal reagent and procedural control. It will appear if the test has been performed correctly and the reagents are reactive.
2. Good laboratory practice recommends the daily use of control materials to validate the reliability of the device. Control materials which are not provided with this test kit are commercially available.