Faecal immunochemical test calibrator for use on the HM-JACKarc analyser

The EXTEL HEMO-AUTO HS Calibrator is a pack of eight vials, 4 x high-level and 4 x low-level calibrators, for use on the HM-JACKarc Faecal Immunochemical testing analyser for local recalibration. The reagent is for use in faecal immunochemical testing for the quantification of haemoglobin in faeces.

Background:
Blood in faeces could be a symptom of a range of gastroenterological complaints: colorectal cancer (CRC), inflammatory bowel disease (IBD), and diverticular disease, for example. The use of a marker such as blood in the stool has been used for CRC screening programmes for over 10-years, originally with a guaiac based, qualitative technology, referred to as faecal occult blood (gFOB). The faecal immunochemical test is now used in symptomatic referral and screening programmes, to help triage patient care appropriately, identify bowel cancer earlier, and improve laboratory workflow.

Product Specification:
The pack contains eight vials of calibrator: 4 x high-level calibrators, and 4 x low-level calibrators for the 2-point local recalibration. Product is provided lyophilised and must be reconstituted with 1 ml of distilled water.

Handling and Storage:
Store in a cool, dark, place at 2 - 8 C. Once reconstituted, the reagent is stable for one week at 2 – 8 C. Aliquots can be frozen for up to one month (-30 C) and thawed prior to use. Once thawed, do not re-freeze. The calibration on the analyser is stable for one week, and recalibration should be performed weekly, or following lot changes of reagent.