98,00

Format

ELISA

REF

GDB4CME3

Regulatory Status

CE 0344

Sample Type

Plasma, Serum

Incubation Time

150 min

Description

An enzyme immunoassay for in vitro qualitative detection of IgM antibody to hepatitis B virus core antigen (Anti-HBc IgM) in human serum or plasma.

 

PERFORMANCE

1541 hospitalized patients were tested. The results are as follows:

PERFORMANCE Test Positive Test Negative
Confirmed Positive 551 1
Confirmed Negative 5 984
Inter-assay precision CV < 25% Intra-assay precision CV < 20%
The diagnostic sensitivity is 96.1%;The diagnostic specificity is 100%

GDB4CME3 – IFU

GDB4CME3 – DoC

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