Alpha-fetoprotein Rapid Test

Intended Use

Alpha Fetal-protein Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of alpha fetal-protein (AFP) in human whole blood, serum, or plasma specimens. Alpha Fetal-protein Rapid Test is intended for use as an aid in the diagnosis of various cancers.

What we should know about AFP?

Alpha Fetoprotein (AFP) is a single chain glycoprotein with a molecular weight of approximatively 70,000. It is produced by the fetal yolk sac and proximal structures of the liver and gastrointestinal tract. In the human fetus, AFP is a major serum protein which reaches a level of several milligrams per milliliter at week 12 of gestation and then drops to trace concentration in the normal non pregnant adult. The clinical value of AFP as a tumor marker was not immediately appreciated because the assays used for quantitation were not sensitive enough to detect the nanogram amounts associated with early disease. As more sensitive radioimmune assays became available, the utility of AFP as a tumor marker became increasingly apparent. Significant increases are observed in malignant tumours in childhood, such as hepatoblastomas and nephroblastomas, and in hepatocellular carcinoma and certain testicular tumours in adults. Less commonly, malignant tumours of the gastro¬intestinal tract and other organ systems with massive hepatic metastases are associated with increased concentractions of AFP in serum or plasma. AFP levels should be measured at presentation and monitored during treatment and they are very useful in diagnosis and in evaluating the effectiveness of therapy.

Storage and Stability

● The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.

● The test must remain in the sealed pouch until use.

● Do not freeze.

● Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.

Specimen Collection and Storage

● Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.

● Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.

● Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.

● If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.

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