Description

For professional use only.

Rapid test cassette for IgG / IgM COVID-19 (Whole Blood / Serum / Plasma) manufactured by Zhejiang Orient Gene Biotech Co.,Ltd

PRODUCT INFORMATION:
The COVID-19 rapid IgG / IgM test cassette (whole blood / serum / plasma) is a test
Solid-phase immunochromatography for rapid, qualitative, and differential detection of the
IgG and IgM antibodies to New Coronavirus 2019 in human whole blood, serum or
In the plasma.

USAGE:
15-minute rapid test for SARS-CoV-2 antigen
Simple procedure
All the necessary reagents are provided and no other products are needed
Detects suspected cases of COVID-19 in the first few days after the onset of symptoms
PACKAGE CONTENTS:
25 sealed envelopes each containing one test cassette
one dropper and one desiccant 25 buffer
1 package insert
LIMITATIONS:
Use fresh samples whenever possible. Frozen and thawed samples (especially repeatedly) contain particles that can block the membrane. This slows the flow of reagents and can lead to a high background color, making interpretation of results difficult.
Optimal dosing performance requires strict adherence to the dosing procedure described in this leaflet. Deviations can lead to aberrant results.
A negative single-subject result indicates the absence of detectable anti-COVID-19 antibodies. However, a negative test result does not preclude the possibility of COVID-19 exposure or infection.
A negative result may occur if the amount of anti-COVID-19 antibodies present in the sample is below the detection limits of the test or if the detected antibodies are not present during the stage of the disease in which a collected sample is present.
PERFORMANCE CHARACTERISTICS:
The sensitivity of the IgG / IgM test is 96.19% (429/446).
The specificity is 100% (344/344) compared with RT-PCR.
The accuracy of the IgG / IgM test is 97.85% (773/790).