Singclean® COVID-19 IgGIgM Rapid Test Kit CII001
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Export Approval from the Ministry of Commerce COVID-19 IgG/IgM Test Kit (Colloidal Gold Method) Precise Rapid Sensitive Hangzhou Singclean Medical Products Co.,Ltd.

COVID-19 IgG/IgM Test Kit (Colloidal Gold Method) Intended Use Singclean® COVID-19 IgG/IgM Test kit（Colloidal Gold Method）is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to Novel 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 with alternative testing method(s) and clinical findings. Fever Fatigue Cough Shortness of...

COVID-19 IgG/IgM Test Kit (Colloidal Gold Method) Product Information Product Name Singclean® COVID-19 IgG/IgM Test Kit (Colloidal Gold Method) Colloidal Gold Method Design Principle Qualitative/ Quantitative Serum/Plasma/Whole Blood Required Volume of Specimen Package Contents 1 Instruction 5 Buffers 20 Test Kits 20 Lancets 20 Disposable Micropipettes 20 Alcohol Tablets 1 Instruction 1 Buffer 1 Test Kit 1 Lancet with Instruction 1 Disposable Micropipette 1 Alcohol Tablet Storage and Stability The kit can be stored at room temperature or refrigerated (4-30°C). The test device is stable...

COVID-19 IgG/IgM Test Kit (Colloidal Gold Method) Product Advantages PCR Nucleic Acid Test IgG/IgM Antibody Test Result Time Facility Requirement No special facilities needed but should only be operated by healthcare workers Sample requirement Saliva, nasal, oral or anal swabs Whole blood, serum & plasma Clinical Value Commonly used, gold standard Can be used in large scale, and can detect symptomatic or asymptomatic patients, patients who in the late or recurrent stage of infection 1. High exposure risk to health workers when collecting samples 2. High false negative rate; low sensitivity...

COVID-19 IgG/IgM Test Kit (Colloidal Gold Method) Clinical Data The COVID-19 IgG/IgM detection kit (whole blood/serum/plasma) was evaluated with 1020 specimens. The results were compared with clinical diagnosis (based on RT-PCR). Total Relative sensitivity Relative specificity Global Network Singclean® COVID-19 IgG/IgM Test Kit has been sold to more than 50 countries in the world, like Brazil, Chile, Poland, Spain, Bolivia, Greece, Lithuania, Ecuador, Ukraine and Turkey.

COVID-19 IgG/IgM Test Kit (Colloidal Gold Method) Test Method Limitations •The results of this test are for clinical reference only and should not be the only basis for diagnosis. Results should be used in combination with clinical observations, like CT images and other testing methods. Studies have shown that the combination of nucleic acid testing and antibody testing could effectively improve the detection rate. •A false negative may occur if the amount of COVID-19 IgM or IgG antibody is below the detection level of the kit. •It is not recommended to use the Product within 7 days after...

COVID-19 IgG/IgM Test Kit (Colloidal Gold Method) COVID-19 Testing FAQs 3. What can cause a false negative result? a. Individual differences in test kits themselves; b. Concentration of antibodies in the blood is low and doesn't reach the detection limit, it will also cause false negative; c. The amount of blood added during the test may be insufficient; d. Patients are at the early stage of infection and antibodies have not been produced. e. False negative results can occur in elderly and immunocompromised patients. 4. What does it mean if the specimen tests positive for COVID-19 IgM/IgG...

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