Specimen: whole blood, serum or plasma
INTENDED USE: The Strong Step® SARS-CoV-2 IgM/IgG Test is a rapid immunochromatographic assay for the simultaneous detection of IgM and IgG antibodies to SARS-CoV-2 virus in human whole blood, serum or plasma. The assay is used as an aid in the diagnosis of COVID-19.
INTRODUCTION: Coronavirues are enveloped RNA virus that are distributed broadly among humans, other mammals and birds, that cause respiratory, enteric, hepatic and neurologic diseases. Seven coronavirus species are known to cause human disease. Four virus - 229E, OC43, NL63 and HKU1 – are prevalent and typically cause common cold symptoms in immunocompetent individuals. The three other strains – severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV) and 2019 Novel Coronavirus (COVID-19) – are zoonotic in origin and have been linked to sometimes fatal illness, IgM and IgG antibodies to 2019 Novel Coronavirus can be detected with 1-2 weeks after exposure. IgG remains positive , but the antibody level drops overtime.
PRINCIPLE: The StrongStep® SARS-CoV-2 IgM/IgG Test utilizes the principle of Immuno-chromatography. Mouse anti-human IgM and human IgG antibodies are immobilized on the nitrocellulose membrane respectively, as two individual test lines (IgM line and IgG line) in the test window of the test device. As the test sample flows through the membrane within the test device, the colored–SARS-CoV-2 specific recombinant antigen-colloidal gold conjugate complexes with specific antibodies (IgM and/or IgG) of SARS-CoV-2 virus, 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 results. 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- SARS-CoV-2 virus antibodies in the specimen.
KIT COMPONENTS: 1. StrongStep® SARS-CoV-2 IgM/IgG Test Card in foil pouch
2. Sample Buffer
3. Instructions for Use
MATERIALS REQUIRED BUT NOT PROVIDED: 1.Sepcimen collection container
2.1-20 μL Pipetter
3.Timer
PRECAUTIONS: 1. This kit is for IN VITRO diagnostic use only.
2. This kit is for PROFESSIONAL use only.
3. Read the instructions carefully before performing the test.
4. This product does not contain any human source materials.
5. Do not use kit contents after the expiration date.
6. Handle all specimens as potentially infectious.
7. Follow standard Lab procedure and biosafety guidelines for handling and disposal of potentially infective material. When the assay procedure is completed, dispose specimens after autoclaving them at 121º C for at least 20 minutes. Alternatively, they can be treated with 0.5% Sodium Hypochlorite for 1-2 hours before disposal.
8. Do not pipette reagent by mouth and no smoking or eating while performing assays.
9. Wear gloves during the whole procedure.
STORAGE AND STABILITY: The sealed pouches in the test kit may be stored between 2-30ºC for the duration of the shelf life as indicated on the pouch
SPECIMEN COLLECTION AND STORAGE: 1. No prior special preparation of the patient is required before samplecollection by approved techniques.2. The test works best on fresh whole blood / serum / plasma samples.If testing cannot be performed immediately,serum / plasma may bestored at 2-8ºC up to 3 days in case of delay in testing. For long-termstorage, serum /plasma specimens can be frozen at -20ºC for 3 monthsor -70ºC for longer period. Blood samples collected with a suitableanticoagulant such as EDTA or Heparin or Oxalate may be stored at2-8ºC up to 3 days. Blood samples should not be frozen.3. Repeated freezing and thawing of the specimen should be avoided.4. Do not use haemolysed, clotted, contaminated, lipamic and viscous/turbid specimen.5. Specimen containing precipitates or particulate matter must becentrifuged and the clear supernatant only used for testing.6. Do not inactivate the sample by heating.
7. Shipment of specimens should comply with local regulations fortransportation of etiologic agents.
QUALITY CONTROL: 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.
1.Good Laboratory Practicere commends the daily use of control materials to validate the reliability of the device.
LIMITATIONS OF THE TEST: 1. The test is for qualitative detection of anti- SARS-CoV-2 antibody in human serum, plasma or blood sample and does not indicate the quantity of the antibodies.
2. The test is for in vitro diagnostic use only.
3. As in case of all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test but should rather be made after all the clinical findings have been evaluated, especially conjunct with SARS-CoV-2 PCR test.
