COVID-19 POC Tests

COVID-19 Rapid Antigen Test

Intended Use

Singclean CE Marked COVID-19 Test Kit (Colloidal Gold Method) for Antigen Testing is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen from COVID-19 in human nasal swab specimen.

This rapid antigen test kit is the second test kit developed by Singclean Medical for COVID-19 testing on the basis of Colloidal Gold Method after Singclean COVID-19 IgG/IgM Test Kit, an antibody test, was launched globally in March.

Features

•Enable testing on a massive scale

•For healthcare workers use only

•Results ready in 15 minutes

•Accurate diagnostic tool for active infection

•Easy to administer and read results

•Affordable, no need for instrument, highly portable

COVID-19 Rapid Test

Singclean IgG/IgM Rapid Test Kit is now launched to help detect patients infected with COVID-19 quickly and accurately. IgG/IgM Antibody Test has been stated in China Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7) as an effective testing method and evidence for Confirmed cases. And IgG/IgM antibody test is strongly recommended by Dr. Nanshan Zhong, China’s leading expert on COVID-19 during the outbreak to rapidly identify a large number of infected patients and asymptomatic carriers.

IgG/IgM Test Advantages:

1. Easy to use: no special facilities needed

2. Fast: results can be read in 10-15 minutes

3. Precise: its sensitivity is higher than PCR Nucleic Acid

It should be noted that COVID-19 IgG/IgM Test Kit is used as auxiliary diagnosis for patients infected with COVID-19 and should not be the final basis for diagnosis. It is ideal for detecting suspected patients identified as being negative in nucleic acid test. Antibody test in combination with other testing methods can help improve the detection rate.

The most important thing is that COVID-19 IgG/IgM Test Kit should be operated by healthcare workers. Use by non-healthcare professionals can lead to deviation in test results.

Available:

Singclean COVID-19 IgG/IgM Combined Test kit(Colloidal Gold Method)

Result Interpretation:

IgM Positive: early during infection; IgM antibodies normally appear 7 days of symptom onset

IgG Positive: people are infected and were infected. IgG antibodies can persist for years to protect patients from getting infected again

IgM and IgG Negative: never get infected

Test Method Limitations

•Negative results may be caused by low concentrations of the novel coronavirus IgG/IgM antibody in the sample and therefore cannot completely rule out the possibility of infection.

•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.

•Test results can be affected by temperature and humidity.

https://utsuygulama.saglik.gov.tr/UTS/vatandas#/vatTibbiCihazListele

You can check the approval status of our products and the other medical devices you are using in Turkey at Product Tracking System (UTS) (this site is in Turkish).

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