Testing Kit Igm/Igg Antiboday Diagnostic Kit

1. Specificity Study: No cross-reactions showed in below validation process.a. Internal enterprise controls including negatives and cross-reaction samples ( other frequent respiratory infectious disease patients\'serum)b. Official sampling validation performed by National Industries for Food and Drung Control (China) and ac

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1. Specificity Study:

 
No cross-reactions showed in below validation process.
a. Internal enterprise controls including negatives and cross-reaction samples ( other frequent respiratory infectious disease patients'serum)
b. Official sampling validation performed by National Industries for Food and Drung Control (China) and achieved PASS.
 
2. Sensitivity Study:
 
Total Combined (IgM+igG)
Early Stage (IgM+IgG)
Mid-late Stage (IgM+IgG)
IgM
IgG
Total Confirmed Cases(by PCR)
203
58
143
203
203
Positive
185
44
140
165
170
Negative
18
14
3
38
33
Sensitivity
91.1%
75.9%
97.9%
81.3%
83.7%

 

 
3. Adbanced Confirmed ( before positive PCR result) Cases Study:
 
8 antibody postive cases ( sympomatic/asymptomatic) found before PCR confirmation ( one even with 11 negative results in a row) then confirmed within days. Such indication is not priority study in China therefore no clinical enrollment carried out.

Testing Kit Igm/Igg Antiboday Diagnostic Kit

 

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