The CLEARTEST® HAV IgG/IgM Rapid Test is a qualitative chromatographic immunoassay for the simultaneous detection of IgG and IgM antibodies against the hepatitis A virus (HAV) in whole blood, serum, or plasma samples . Based on proprietary immunochromatographic technology combined with fluid dynamics, the test delivers reliable results within 15 minutes . It serves as an aid in the diagnosis of acute or past hepatitis A infection and is intended exclusively for use by healthcare professionals in professional in vitro diagnostic settings.

Application areas

Rapid diagnostics for suspected hepatitis A
Differentiation between acute (IgM) and past (IgG) infection
Use in clinics, laboratories, practices or screening facilities
Suitable for whole blood, serum or plasma

Advantages at a glance

Rapid combination detection of IgG and IgM antibodies against HAV
High-quality immunoassay – results in just 15 minutes
Simple 3-step procedure (sampling, preparation, testing)
High sensitivity and specificity for both antibody classes
Performed using whole blood, serum or plasma
No additional equipment required
Ideal for professional point-of-care diagnostics

Performance features

IgG detection
Sensitivity: 97.9% (95% CI: 95.5% – 99.0%)
Specificity: 99.1% (95% CI: 97.3% – 99.8%)
Accuracy: 98.4% (95% CI: 97.2% – 99.2%)

IgM detection
Sensitivity: 95.7% (95% CI: 90.2% – 98.6%)
Specificity: 99.1% (95% CI: 98.0% – 99.7%)
Accuracy: 98.6% (95% CI: 97.4% – 99.3%)

Further information

HAV is an RNA virus from the Picornaviridae family and is primarily transmitted via the fecal-oral route. The detection of specific IgM antibodies indicates an acute or recent infection , while IgG antibodies can indicate a past infection or vaccine immunity . The test is particularly helpful in assessing immune status and infection risk – including in the context of epidemiological studies.

For professional in-vitro diagnostics only

Producer:

Servoprax GmbH

Am Marienbusch 9

46485 Wesel