Check4® Haemoglobin

The method employs a unique combination of monoclonal dye conjugate and polyclonal solid phase antibodies to selectively identify human haemoglobin with a high degree of sensitivity and specificity. After collection in a special collection device containing extraction solution, the sample is dissolved and the strip test is put into the extract. As the test sample flows through the absorbent pad, the labelled antibody-dye conjugate binds to the haemoglobin antigen forming an antibody antigen complex. The extract-colloidal gold mixture (antigen-antibody complex) moves by capillary action along the strip forming a line of immobilized complex at the antibody zone in the test region indicating the presence of haemoglobin antigen in the extract (pink coloured line). If no antigen is present the test zone will remain clear. Check4® Haemoglobin has an integral control feature. The appearance of a pink coloured line in the control zone of the test strip, formed of immobilized colloidal gold mixture, shows that the test has been carried out correctly.

Colorectal cancer has an annual incidence worldwide of more than 600,000 cases and ranks as the third most common cancer. As it is true for all cancers, early detection of the lesions considerably increases the survival rates of the patient. Among persons over 45 years, 10% have colorectal polyps from which 1% will become malignant. Relying on the fact that many polyps larger than 0.5 cm can bleed, faecal occult blood testing appears to be a simple and cheap screening method for colorectal cancer compared to colonoscopy.

1.This test is designed for in vitro diagnostic use and for professional use only.
2.Please read the instruction leaflet carefully before using this test.
3.Do not use beyond the expiry date which appears on the package label.
4.Unused strips should be kept stored in the sealed container.
5.All reagents and materials coming in contact with potentially infectious specimens must be treated with appropriate disinfectants or autoclaved at +121°C for at least one hour.
6.Wear protective clothing such as laboratory coats and disposable gloves while assaying samples.
7.Avoid any contact between hands and eyes or nose during specimen collection and testing. Extraction reagents may cause irritation to skin, eyes and mucus membranes. Wash off immediately if extraction reagents come into contact with skin.
8.Do not eat or drink in the area where specimens and kit reagents are handled.

If there is no distinct coloured band visible in the control window, the test is invalid. It is recommended that in this case the test be repeated with a fresh test strip. The remaining extraction mixture in the same collection device can be used for this purpose.

To assess the value of Check4® Haemoglobin, 135 symptomatic patients (people from whom complaints justified an examination by colonoscopy) were assayed with Check4® Haemoglobin and HEMOCULT II (SKD, California USA). Three stool specimens from three bowel movements were collected. A patient was considered positive in the test if one sample at least was found to be positive.

The results obtained using Check4® Haemoglobin and HEMOCULT II were then correlated with the clinical results of the colonoscopy. The results obtained using Check4® Haemoglobin (sensitivity 57%/Specificity 91%/Accuracy 81%) were consistently better than the results obtained using HEMOCULT II.

For more information you can visit the below:

• https://www.nhs.uk/conditions/bowel-cancer/
• https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bowel-cancer/incidence