Singclean Covid-19 IgM/IgG antibody rapid test
Product code: P1599
The Singclean® COVID-19 IgG / IgM Test Kit (colloidal gold method) is a solid phase immunochromatographic test for rapid, qualitative, and differential detection of IgG and IgM antibodies against a new coronavirus in human whole blood, serum, or plasma to help reduce the spread of COVID- 19. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM test kit (colloidal gold method) must be confirmed by alternative test methods and clinical findings. Not intended for home use.
The COVID-19 IgG / IgM test kit (colloidal gold method) is a solid phase immunochromatographic test for rapid, qualitative, and differential detection of IgG and IgM antibodies against a new coronavirus in human whole blood, serum, or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG / IgM test kit (colloidal gold method) must be confirmed by alternative method(s) and clinical findings.
1 rapid test set
The new coronaviruses belong to the genus β. COVID-19 is an acute respiratory infectious disease. Humans are generally prone to infection. Currently, the main source of infection is patients infected with the new coronavirus; asymptomatically infected people can also be a source of infection. Based on the current epidemiological inquiry, the incubation period is 1 to 14 days, usually 3 to 7 days. The main symptoms include fever, fatigue, and dry cough. In several cases, there is a stuffy nose, runny nose, sore throat, myalgia, and diarrhoea.
PRINCIPLE OF THE TEST
The COVID-19 IgG / IgM test kit (colloidal gold method) uses the principle of immuno-chromatography on colloidal gold. The assay uses anti-human IgM (IgM test line), anti-human IgG (IgG test line) and goat anti-mouse IgG (control line C) antibodies immobilized on a nitrocellulose strip. The burgundy-coloured conjugate pad contains colloidal gold conjugated to colloidal gold-conjugated recombinant COVID-19 antigens (COVID-19 conjugates). When sample and assay buffer, IgM and / or IgG antibodies, if present, are added to the sample well, they bind to COVID-19 conjugates to form a complex of anti-antigen antibodies. This complex migrates through the nitrocellulose membrane by capillary action. When the complex encounters a line corresponding to an immobilized antibody (anti-human IgM and / or anti-human IgG), the complex is captured and a burgundy-coloured line is formed, which confirms the result of the reactive test. The absence of a coloured bar in the test area indicates a non-reactive test result.
Regardless of the presence of COVID-19 IgG/IgM antibody in the test sample, a coloured bar appears on the quality control line (line C). The coloured bar on the quality control line (line C) is used to determine if the sample is sufficient and that the chromatographic process meets the normal standard and serves as an internal control standard for the reagent.
- sealed packet, each containing a test cassette
- lancets (only for whole blood from the finger)
- sterilization tablet (only for whole blood from the finger)
Required material not included:
- sampling containers
- centrifuge (plasma only)
STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (4-30°C). The test device is stable until the expiration date printed on the sealed packet. The test equipment must remain in the closed housing until use. Protect from frost.
Do not use after the expiry date.
WARNINGS AND PRECAUTIONS
- For professional in vitro diagnostic use only. Do not use after the expiry date.
- Read the package leaflet before the test. Failure to follow the instructions may result in inaccurate test results.
- Do not use it if the tube (packet) is damaged or broken.
- The test is for single use only. Under no circumstances should you reuse it.
- Treat all specimens as if they contain infectious agents. During testing, follow established precautions against microbiological risks and follow standard procedures for proper sample disposal.
- Wear protective clothing such as lab coats, disposable gloves, and eye protection when testing specimens.
- Humidity and temperature may adversely affect results.
- Do not perform the test in a room with strong air flow, i.e. electric fan or strong air conditioning.
- COVID-19 IgG / IgM (colloidal gold method) test kit (hereinafter referred to as the product) used to detect antibodies produced by the human body against COVID-19 after infection. COVID-19-positive patients may be tested negatively with this product because the human body did not produce or produced very few antibodies at the time that the product detects.
- The product should only be used as an adjunct in patients infected with COVID-19 and should not be the definitive diagnosis of COVID-19 infection. It must be combined with other medical tests for a comprehensive diagnosis.
- The product is intended for use by healthcare professionals. It should be performed by health professionals. Not intended for home use.
- Used reagents and accessories should also be treated as a source of infection and treated as biohazardous waste.
- COVID-19 IgG / IgM Test Kit (The colloidal gold method) can be performed using either whole blood, serum, or plasma.
- Separate serum or plasma from blood as soon as possible to prevent haemolysis. Use only clear, haemolyzed specimens.
- Testing should be performed immediately after sampling. Do not leave samples at room temperature for extended periods of time. Serum and plasma samples can be stored between 2-8°C for up to 3 days. During long-term storage, samples should be stored below -20 ° C. Whole blood collected by venepuncture should be stored between 2-8 ° C if the test is to be performed within 2 days of collection. Do not store whole blood samples. Whole blood drawn from a finger should be examined immediately.
- Bring samples to room temperature before testing. Frozen samples must be completely thawed and mixed well before testing. Samples should not be repeatedly frozen and thawed.
- If samples are to be sent, they should be packed in accordance with local regulations for the transport of etiological substances.
PERFORMANCE OF THE TEST
Allow the test cassette, sample, and antigen extraction buffer to equilibrate to room temperature (15-30 ° C) before testing.
- Remove the test cartridge from the sealed foil pouch and use it as soon as possible. The best results will be obtained if the test is performed within one hour.
- Place the test device on a clean and level surface.
For serum or plasma samples:
Use the supplied dropper to take a serum/plasma sample, and then add 1 drop of serum / plasma sample to the sample well (S). Then immediately add 2 drops of buffer to the sample well (S). Avoid air bubbles.
For a whole blood sample:
- Using the supplied dropper, transfer 1 drop of whole blood to the sample well (S) of the test device, then immediately add 2 drops of buffer to the sample well (S). Avoid air bubbles.
- Wait for the coloured lines to appear. The result should be read after 10 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
If only line C is present, the absence of any burgundy colour in both T lines (IgG and IgM) indicates that no anti-COVID-19 antibodies are detected in the sample. The result is negative.
In addition to the presence of line C, if only the IgM line is developed, the test indicates the presence of anti-COVID-19 IgM in the sample. The result is IgM anti-COVID-19 positive.
In addition to the presence of line C, if only the IgG line is developed, the test indicates the presence of anti-COVID-19 IgG in the sample. The result is IgG anti-COVID-19 positive.
IgG and IgM POSITIVE:
In addition to the presence of line C, both IgG and IgM bands are developed, the test indicates the presence of both anti-COVID-19 IgG and IgM in the sample. The result is IgG and IgM anti-COVID-19 positive.
The control line does not appear. The most likely reason for a control line failure is insufficient sample volume or incorrect procedures. Check the procedure and repeat the test with a new test cartridge. If the problem persists, stop using the test kit immediately and contact your local distributor.
Procedural control is part of the test. The red line in the control area (C) is the internal procedural control. It confirms a sufficient sample volume and correct procedural technique.
Control standards are not included with this kit; however, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.
- If possible, use fresh samples. Frozen and thawed samples (especially repeatedly) contain particles that can block the membrane. This slows down the flow of reagents and can lead to a high background colour, which makes it difficult to interpret the results.
- Optimal test performance requires strict adherence to the test procedure described in this package insert. Deviations can lead to incorrect results.
- A negative result in an individual subject indicates the absence of detectable COVID-19 antigen (SARS-CoV-2). However, a negative test result does not rule out the possibility of exposure or infection to COVID-19.
- A negative result may occur if the amount of anti-COVID-19 antibodies present in the sample is below the detection limits of the assay or if the detected antibodies are not present during the disease stage at which the sample is taken.
- Some samples containing unusually high titers of heterophile antibodies or rheumatoid factor may affect the expected results.
- As with all diagnostic tests, the final clinical diagnosis should not be based on the result of a single test but should be made by a physician only after all clinical and laboratory findings have been evaluated.
The COVID-19 IgG/IgM detection kit (whole blood/serum/plasma) was evaluated with 1020 samples. The results were compared with the clinical diagnosis (based on RT-PCR).
1. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011; 81: 85-164.
2. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016; 24: 490-502.
Hangzhou Singclean Medical Products Co., Ltd.
No. 125(E), 10th street, Hangzhou Economic and Technological Development Zone, Zhejiang, China.P.C.: 310018
Representative in Europe
SUNGO Europe B.V.
Add: Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
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