Set of 4 pcs. 2019-nCoV IgM/IgG Antibody Test Kit
Included in each kit
- Test cassette
- Buffer（1 vial，5mL）
Quantity: 4 test kits
- Bring the kit to room temperature (15-30°C). Shake and ensure the buffer has thawed well. Allow it to equilibrate before proceeding.
- Prick the finger using the lancet.
- Wipe the first drop of blood with a clean cloth.
- Squeeze and hold the dropper, and aim the dropper’s nozzle at the small wound.
- Gently press near the wound, then slowly release the dropper to draw the blood released. Drawn blood has to be at least 1 cm above the fill line (from the nozzle and past the thin part of the dropper).
- Holding the dropper vertically, transfer the drawn blood onto the test cassette’s well (recessed circle marked as “S”). At least a full drop must be transferred.
- Add 2 drops of the buffer into the cassette’s well.
- Wait for 10 minutes (and not much further, or the test will be invalid).
How to Tell if Positive?
A positive result is determined by either of the three below:
- A colored line on both C and IgM fields.
- A colored line on both C and IgG fields.
- A colored line on all fields (C, IgG and IgM).
On the other hand, a negative result is determined by a single colored line on the “C” field.
Results different from the above are considered invalid.
- Mark a number in the cassette so you can keep track of its usage.
- Best results will be obtained if the test is performed within one hour of opening the pouch.
- Place the test cassette on a clean and level surface.
- Avoid trapping air bubbles in the specimen well.
- After observing and recording the results, please discard the test card to avoid confusing the result judgment. For long-term storage, take photos of the results.
The cassette is used for the qualitative detection of new Coronavirus IgM and IgG antibodies in human whole blood, serum or plasma.
Currently there are seven types of human Coronaviruses (HCoV), which are important pathogens of human respiratory infections that can cause human respiratory diseases:
- New Coronaviruses (2019-nCoV)
Among them, the new coronavirus (2019-nCoV) was discovered due to the virus pneumonia cases in Wuhan, 2019. The clinical manifestations are systemic symptoms such as fever and fatigue, accompanied by dry cough and dyspnea. It can quickly develop into severe pneumonia, respiratory failure, acute respiratory distress syndrome, septic shock, multiple organ failure, severe acid-base metabolism disorders, etc., are even life-threatening.
When infected with the new coronavirus, IgM antibody is produced in 3-7 days firstly, then replaced by a large number of IgG antibodies two weeks later. Thus, the presence of new Coronavirus IgM and IgG antibodies can be used for auxiliary diagnosis of suspected patients.
The test method is immunochromatographic — the membrane is pre-coated with recombinant anti-human IgG/IgM antibodies on the test line region of the cassette. During testing, the whole blood, serum or plasma specimen reacts with recombinant anti-human IgG/IgM antibodies conjugated in colloid gold. The sample migrates upward on the membrane chromatographically by capillary action to react with recombinant anti-human IgG/IgM antibodies on the membrane.
To serve as a procedural control, a colored line will always appear at the control line region (C) indicating that proper volume of specimen has been added and membrane wicking has occurred.
If the sample contains IgM antibodies, a colored line will generate on the IgM line.
If the sample contains IgG antibodies, a colored line will generate on the IgG line.
Store in 2-30°C.
The test cassette is stable throughout the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO NOT FREEZE.
- For professional in vitro diagnostic use only. Do not use after expiration date.
- Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
- Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
- Humidity and temperature can adversely affect results.
- The test can be performed using whole blood, serum or plasma. Includes plasma samples prepared with commonly used anticoagulants (EDTA, heparin, sodium citrate).
- Separate the serum or plasma from blood as soon as possible to avoid hemolysis. Only clear, non-hemolyzed specimens can be used.
- Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Specimens mustbe stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.
- Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
- If the sample contains a large amount of lipid, hemolysis or turbidity, please do not use it.