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.

Easy, Fast, & Precise

Performance Report

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.

Method

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.

Results

Regarding the COVID-19 IgM – Agreement with RT-PCR

• Clinical Sensitivity 87.01%
• Clinical Specificity 98.89%
• Accuracy Rate 93.41%

Regarding the COVID-19 IgG

• Clinical Sensitivity 99.42%

Frequently Asked Questions

What is the Rapid COVID-19 specific IgM and IgG test?

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.

How long does it take? Does it require any laboratory equipment?

It takes about 15 minutes and does not require any laboratory equipment.

What Test is the diagnostic for COVID-19 infection?

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.

Who is a candidate for the Rapid COVID-19 specific IgM and IGG test?

• For Asymptomatic patients mainly
• Patients with mild symptoms
• People who have been in close contact with an individual suspected of or confirmed to have COVID-19

Who is NOT a candidate for the Rapid COVID-19 specific IgM and IGG?

• People who are sick and symptomatic.
• Fever, dry cough, shortness of breath, chills and body aches. Loss of smell- taste, fatigue.

Why are symptomatic patients not good candidates for the Rapid COVID-19 specific IgM and IGG?

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.

What test is diagnostic for COVID-19 infection?

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.

Is the serologic test FDA-approved or cleared?

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.

How did Fleur Women’s Health became the first Health Care Provider in The Coachella Valley to offer the Rapid Covid 19 IgM and IG serologic test?

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.