Singclean® COVID-19 IgGIgM Rapid Test Kit CII001

Product catalog summary

Intended Use
The Singclean® COVID-19 IgG/IgM Test Kit (Colloidal Gold Method) is designed for the rapid, qualitative detection of IgG and IgM antibodies to the Novel Coronavirus in human blood, serum, or plasma. It is intended to help reduce the spread of COVID-19 by providing preliminary test results, which must be confirmed with alternative methods and clinical findings.

Main Symptoms and Antibody Generation
Symptoms of COVID-19 include fever, fatigue, cough, and shortness of breath. IgM antibodies appear early in the immune response, typically 7 days after symptom onset, while IgG antibodies appear later, around 10 days after symptom onset, and can remain detectable for months.

Product Information
The test kit uses a colloidal gold method and requires a small volume of specimen (serum, plasma, or whole blood). It is qualitative and based on a sandwich design principle. The kit includes test kits, buffers, lancets, micropipettes, and alcohol tablets, and is available in packages of 1 or 20 tests.

Storage and Stability
The kit should be stored at room temperature or refrigerated (4-30°C) and must not be frozen. It remains stable until the expiration date on the sealed pouch.

Test Procedures and Result Interpretation
Results are interpreted based on the presence of lines for IgG and IgM. The test provides results in 10 minutes and should be conducted by healthcare workers.

Product Advantages
Compared to PCR tests, the IgG/IgM test is faster (10 minutes) and does not require special facilities, though it should be conducted by healthcare professionals. It can be used on a large scale and detects both symptomatic and asymptomatic patients.

Clinical Data
The test kit has been evaluated with 1020 specimens, showing a relative sensitivity of 96%, specificity of 98.29%, and accuracy of 97.84% when compared with RT-PCR results.

Limitations
The test results are for clinical reference only and should be combined with other diagnostic methods. False negatives may occur if antibody levels are below detection limits, especially within 7 days of symptom onset.

Warnings and Precautions
The test is not intended for home use and should be conducted by healthcare workers. Results should not be interpreted after 20 minutes, and the kit should not be used beyond its expiration date.

FAQs
The document addresses common questions about testing, including who should be tested, the implications of negative and positive results, and the potential for false negatives. It also provides guidance on when to use antibody testing and the validity period of the buffer.

Catalog excerpts

Singclean® COVID-19 IgGIgM Rapid Test Kit CII001-1

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.

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Singclean® COVID-19 IgGIgM Rapid Test Kit CII001-2

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 Breath...

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Singclean® COVID-19 IgGIgM Rapid Test Kit CII001-3

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 through...

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Singclean® COVID-19 IgGIgM Rapid Test Kit CII001-4

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 1....

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Singclean® COVID-19 IgGIgM Rapid Test Kit CII001-5

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.

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Singclean® COVID-19 IgGIgM Rapid Test Kit CII001-6

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 the...

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Singclean® COVID-19 IgGIgM Rapid Test Kit CII001-7

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 Antibodies?...

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Singclean® COVID-19 IgGIgM Rapid Test Kit CII001-8

Dedicated to Healthcare Improvement Hangzhou Singclean Medical Products Co.,Ltd. Add:No.125(E),10th Street, Hangzhou Qiantang New Area, Zhejiang. China P.C.:310018 Tel:+86-571-63431868 Fax:+86-571-63431886 E-mail: [email protected] Web:www.Singclean.net

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