REF:

C5205 (Strip)

C5206 (Cassette)

INTENDED PURPOSE:

NOVAtest® Alpha Fetoprotein Test is an immunochromatographic assay that uses double-antibody sandwich method for qualitative detection of alpha-fetoprotein (AFP) in human serum and plasma specimens. It’s used as an aid of diagnosis of primary hepatocellular carcinomas, testicular teratocarcinomas, and neural tube defects (NTD). This device is performed manually.

INTENDED USER:

Performance of the test is limited to laboratory professional use.

SUMMARY:

Alpha-fetoprotein (AFP), a natural protein founded in foetus amniotic fluid, was discovered in the human foetus in 1956 and has long been recognized as the gold standard among tumourspecific molecular biomarkers.

Hepatocellular carcinoma (HCC), the leading primary malignancy of the liver, is one of the most common cancers globally and results in significant health-related problems. HCC is difficult to treat and manage. The most commonly used biomarker for HCC is serum alpha-fetoprotein. AFP has also been used to detect early tumours in the liver and foetal open neural tube defects4.

The Alpha Fetoprotein Test is intended to be used to detect elevated levels of AFP in human serum and plasma with a cut-off value of 25ng/mL.