PRODUCT

【SUMMARY】

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus.


Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment.  Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.


The best way to prevent and slow down transmission is be well informed about the COVID-19 virus, the disease it causes and how it spreads. Protect yourself and others from infection by washing your hands or using an alcohol based rub frequently and not touching your face. 
The COVID-19 virus spreads primarily through droplets of saliva or discharge from the nose when an infected person coughs or sneezes, so it’s important that you also practice respiratory etiquette (for example, by coughing into a flexed elbow).


At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments. 


The COVID-19 IgG/IgM Rapid Test(Whole Blood/Serum/Plasma) is a lateral flow immunoassay intended for qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anticoagulated blood (EDTA) or serum. The COVID-19 IgG/IgM Rapid Test(Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Any reactive specimen with the COVID-19 IgG/IgM Rapid Test must be confirmed with alternative testing method(s).

【TEST KIT COMPOSITION】

  1. Individually packed test devices
  1. Package insert
  1. Dropper
  1. Buffer Solution
  1. Sterile Lancets (Optional)
  1. Alcohol Pads (Optional)

【TEST PROCEDURE FOR COVID-19 IgG/IgM Rapid Test(Whole Blood/Serum/Plasma)】

HOME USE PROCEDURE

Fill the dropper with the specimen then vertically add 2 drops of specimen into the sample well. Making sure that there are no air bubbles. Then squeeze and add all the Sample Diluent immediately into the sample well.

PROFESSIONAL USE PROCEDURE

1.Collect the specimen by veinpuncture or sterile lancet. Put the device on a clean and flat surface.


2.For whole blood sample: Add 2 drops of specimen into the sample well. Making sure that there are no air bubbles. Then add 2 drops of buffer solution immediately into the sample well.


3.For Plasma/ Serum sample: Add 1 drop of specimen into the sample well. Making sure that there are no air bubbles. Then add 2 drops of buffer solution immediately into the sample well.     


Set up a timer. Read the result at 10 minutes. Don’t read result after 15 minutes. To avoid confusion, discard the test device after interpreting the result.

【INTERPRETATION OF THE TEST RESULTS】

【WARNING STATEMENT】

• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.


• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.


• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains or other interference factors.


•Not for the screening of donated blood.