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Faecal immunochemical test latex agglutination reagent for use on the HM-JACKarc analyser

Product code: 065553

Pack Size: 4 x 18ml
CE Verified: IVDR

Product Information

This EXTEL HEMO-AUTO HS Latex is a highly sensitive reagent, for use on the HM-JACKarc Faecal Immunochemical Testing (FIT) analyser, to quantify the amount 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.
The assay on the HM-JACKarc analyser utilises integrated spherical turbidimetry to accurately determine the concertation of haemoglobin in faeces. The latex molecules are coated in an excess of polyclonal antibodies specific to human haemoglobin: giving a hook capacity of 200,000 µg Hb / g faeces, ensuring even very high results are not artificially reported low. The assay has a wide, linear, range of 7 - 400 µg Hb / g faeces, and a limit of detection of 1.25 µg Hb / g faeces. Being specific to human haemoglobin there are no dietary restrictions required prior to sampling. Each lot of reagent has a factory-set reaction response master curve, which is confirmed by performing a local 2-point recalibration.

Product Specification:
One pack contains four bottles, each containing 18 ml, of latex reagent. Each bottle is sufficient to perform around 200 tests.

Handling and Storage:
Store in a cool, dark, place at 2 - 8 C – do not freeze. The onboard stability is 20 accumulated hours (reaction must occur at room temperature), and open bottle stability when refrigerated (2 - 8 C) is until expiry date.

Specification

  • Brand Minaris Medical
  • Sterile N
  • CE Certified IVDR
  • Warranty Period Standard Terms Apply
  • Is product classified as dangerous goods? No
  • Does the product contain latex? Unspecified

Storage Details

  • Pack Description 4 x 18ml
  • Shipping Condition Blue Ice
  • Storage Condition Fridge
  • Pack Length (m) 0.15
  • Pack Width (m) 0.08
  • Pack Height (m) 0.08
  • Pack Weight (kg) 0.00

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