The COVID-19 lgG/IgM Rapid Test Cassette Zhuhai Livzon Diagnostics, Inc. is a qualitative membrane strip based immunoassay for the detection of antibodies (lgG and lgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. The test cassette consists of:
The lgM line is pre–coated with the Mouse anti-Human lgM antibody, lgG line is coated with Mouse anti-Human lgG antibody. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. lgM anti-Novel coronavirus, if present in the specimen, will bind to the Novel coronavirus conjugates. The immunocomplex is then captured by the reagent pre-coated on the lgM band, forming a burgundy colored lgM line, indicating a Novel coronavirus lgM positive test result. lgG anti-Novel coronavirus if present in the specimen will bind to the Novel coronavirus conjugates. The immunocomplex is then captured by the reagent coated on the lgG line, fanning a burgundy colored lgG line, indicating a Novel coronavirus lgG positive test result. Absence of any T lines (lgG and lgM) suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
This product has CE-IVD registration, and the Certificate of Conformity can be download along with the Instructions for Use and other relevant documents from the manufacturer.
Clungene’s IgM/IgG Rapid Test Cassette for COVID-19 is used to qualitatively detect IgG and IgM antibodies of the Novel coronavirus in human serum, plasma or whole blood in vitro.
The COVID-19 lgG/IgM Rapid Test developed by Zhuhai Livzon Diagnostics, Inc. is for qualitative detection of antibodies (lgG and lgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. By studying the statistical coincident rate, they could validate if it could be used for detection of antibodies (IgG and lgM) to Novel coronavirus in human Whole Blood/Serum/Plasma.
Regarding the IgM test, testing was performed on approximately 167 clinical specimens from Professional Point of Care sites. Regarding the IgM test, the result was compared to RT-PCR. Regarding the IgG test, we have counted the positive rate of the 77 patients during the convalescence period.
Regarding the COVID-19 IgM – Agreement with RT-PCR
Regarding the COVID-19 IgG
It is a rapid serologic test that requires a finger prick blood sample. It is designed for the identification of Covid-19 specific IgM and IgG Immunoglobulins.
It takes about 15 minutes and does not require any laboratory equipment.
A rapid serologic test allows you to identify people who have been exposed to the virus. This information will help to establish the infection rate of the community in general. According to the Centers for Disease Control, 25-50% of people develop mild infections and many of them are asymptomatic.
Because a serologic test does not identify the virus and should not be used to make the Diagnosis by itself. You need a diagnostic test to identify the virus.
A genomic or Molecular Test performed by swabbing your nose or throat. Any viral genetic material found in the sample is amplified by replication and tagged with a fluorescent marker. In a few days you will get millions of copies. Then the virus is identified microscopically. This test requires specialized equipment and trained personal.
No. This test is not yet approved or cleared by the United States FDA. In an effort to balance the urgent need for test availability with testing accuracy, the FDA has issued guidance that enables test developers to begin testing patients prior to the FDA’s review of their validation data. We now have two main types of tests; molecular and serological. The FDA has officially authorized over 20 manufacturers to make molecular tests, and over 40 manufacturers have provided notification that they have validated and are offering serological tests.
You can find our manufacturer Zhuhai Livzon Diagnostics, Inc. listed on the FDA website HERE.
Dr Jacome is the Medical Director of FWH and Pellecome LLC a registered Device company. He has provided services for Bioidentical Hormone replacement Therapy specializing on Pellets for 25 years. He is also the inventor of most the Advanced Pellet Delivery System. We import Parts for the device from China. Our Chinese Broker offered us a new kit for COVID-19 serologic testing and we took the opportunity. Pellecome registered the Clungene Kit with the FDA and became an FDA listed distributor of the device in the USA.