HM-JACKarc References

This presentation, from the World Endoscopy Organisation, is regarding the use of FIT in triaging symptomatic patients, and discusses the various instruments currently available on the market. Focusing on the effectiveness of the HM-JACKarc in evaluating symptomatic patients, the author discusses the uses of the instrument in the screening market. Further outlining the use of FIT in screening programmes, the HM-JACKarc’s low-end sensitivity is described as ‘very useful’ as a rule out test for CRC.

 Fradera, J. M. A. (2015) The Performance of FIT to triage symptomatic patients. World Endoscopy Organisation, Colorectal Cancer Screening Committee. Barcelona 23 Oct 2015 

From the perspective of the testing laboratory, this comprehensive study by the NHS Bowel Cancer Screening Southern Hub, compares and contrasts four FIT analysers and their potential applications in CRC screening. The paper examines attributes including; analytical sensitivity, carryover, imprecision, precision profile, linearity, hook/prozone effect, and sample stability, across the range of analysers. The HM-JACKarc compares favourably in many tests; ease of use, sample and reagent stability, operational performance and precision profile.

 Carroll M. et al (2014) NHS Bowel Cancer Screening Southern Hub – Guildford Medical Device Evaluation Centre 

This study into the effects of sex and age against f-Hb levels concludes that it would be ill-advised to standardise one cut-off value for the entire population when using FIT. Studies in three locations, Scotland, Taiwan, and Italy, where the patients were grouped by age and by sex, indicate that individualisation would be vital to running and maintaining a screening programme beneficial to a whole population.

 Chen, H., Chen, L., Fraser, C., Rapi, S., Rubeca, T. (2014) Clinical Chemistry and Laboratory Medicine. Vol. 52, no. 8, pp. 1211-1216. [online]

This paper highlights the importance of the very high negative predictive value (NPV) of FIT and the application of this in symptomatic patients. Based on continuing research into the effects of calprotectin as a rule-out test, this paper focuses on the importance of the NPV value and ruling out SBD, and not limiting it to the detection of CRC. Using a cut-off faecal Hb concentration of 50 ng Hb/ml (10 µg g^-1) buffer, NPV of 100.0%, 94.4%, 93.4% and 93.9% were found for; CRC, HRA, LRA, and IBD respectively.

 McDonald, P.J., Digby, J., Innes, C., Strachan, J.A., Carey, F.A., Steele, R.C.J., and Fraser, C.J. (2013) Colorectal Disease. Vol. 15, no. 3, pp.151-159. [online]

A study into the cost implications of using FIT over FOBT in a screening programme undertaken in Italy. The report outlines the effectiveness of the HM-JACKarc in identifying low-end levels of f-Hb and the impact this could have on already overstretched endoscopy services. This investigation outlines the importance of low-end sensitivity for the diagnosis of CRC and SBD.

 Confortini, M., Peruzzi, B., Rapi, S., Rubeca, T. (2012) International Journal of Biological Markers, vol. 27, no. 3, pp 195-202. [Online] 

A comprehensive study into the various components of the HM-JACKarc analyser. They conclude that the Extel “Hemo Auto” HS used for the latex agglutination method […] has increased reproducibility.

 Itoh M. et al (2011) Journal of Clinical Laboratory Instruments and Reagents, Vol. 34, No. 3, pp. 387-392

When using the cut-off value for the clinical sensitivity and specificity recommended with each reagent kit, we did not find any major differences for the different assay methods. The sensitivities of the different methods were compared on the broad distinction between early and progressive cancer. The result for early cancer was 17 – 50% and for progressive cancer 83 – 92%. Thus there was a marked difference between the two.

Nakayasu S. et al (2016) Matsuda Hospital

In conclusion, the EXTEL HEMO-AUTO MC Collection Picker is robustly designed so that excess faecal sample loaded by participants, or material remaining in the dimple(s) does not affect the f-Hb.

Zahida, Z., et. al. (2021) Annals of Clinical Biochemistry. DOI: 10.1177/0004563220976749

Use of correct nomenclature for the lowest f-Hb that can be used in academic and routine practice is urgently needed, as are reporting strategies, with harmonisation across manufacturers, suppliers, researchers, reviewers, journal editors and all users.

Fraser C., Benton S., (2018) Presentation from United European Gastroenterology (UEG) week, Vienna

The mass of sample loaded onto the probe did not impact the f-Hb significantly using all four tested devices.

Piggott C. et al. (2018) Annals of Clinical Biochemistry. Vol. 55, no. 6, pp. 702-705

Of 20 common Hb variants studied, 17 did not affect detection of Hb by the FIT systems tested. Hb variants leading to a reduction in the presence of a globin chain caused a reduction in Hb detection; in such cases, cancers could be missed.

 Carroll M. et al. (2018). Annals of Clinical Biochemistry. Vol. 55, no. 06, pp. 706-709

This study concludes that FIT is suited for use as a rule-out test due to its high NPV. The diagnostic yield of collecting two samples for FIT can be achieved with one sample, but a lower faecal haemoglobin concentration (f-Hb) cut-off is required. The use of the HM-JACKarc in this study emphasises the value of low-end sensitivity, and the reduced cut-off level would be sufficient to reduce the requirement for two patient samples.

 Auge, J.M., Castells, A., Fraser, C., Grau, J., Jimenez, W., Lopez-Ceron, M., Rodriguez, C., Roset, R. (2016) Clinical Chemistry and Laboratory Medicine. Vol. 54, no. 1, pp. 125-132. [online]

Comparing two protocols, one using artificial biological samples, and the other using clinical samples, it was possible to determine the effect of preanalytical and analytical variation. The HM-JACKarc was compared favourably with another analyser and both machines indicate that the sample collection devices were key to reducing preanalytical and analytical errors.

 Cellai, F., Confortini, M., Fraser, C., Rapi, S., Rubeca, T. (2015). The International Journal of Biological Markers. Vol. 30, no. 3, pp. 269-345. [online]

When applied to FIT negative group, urinary VOCs improves CRC detection (sensitivity rises from 0.80 to 0.97)   thus showing promise as a second stage test to complement FIT in CRC detection.

 Widlak, M. et al. (2018) Colorectal Disease

Moreover, the FIT results should not be taken in isolation, but clinical impressions and the results of other investigations, probably including the full blood count, should be considered. Challenges still exist, however, and harmonisation of aspects of the available FIT analytical systems is required. Moreover, a number of seemingly valid clinical concerns remain and these require resolution through further research and reporting of studies done in real clinical practice.

Fraser CG. (2018) The Surgeon, Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland. Vol. 16, pp 302-308

In this low-risk symptomatic patient group, the proportion of samples considered positive by FIT was considerably lower than gFOB with the same rate of colorectal adenocarcinoma detection. One in three of those with positive FIT had a significant colorectal disease. This supports National Institute of Health and Care Excellence recommendation that FIT can be reliably used as a triage test in primary care without overburdening endoscopy resources.

 Nicholson BD, et al. (2018) Frontline Gastroenterology

The fully automated fecal occult blood test analyser HM-JACK was shown to yield basically favourable intra- and inter-day precision and accuracy, sufficient measurement range, and stability of HB after stood sampling, among other features. This analyser is fast and easy to use, analysing 180 samples per hour. […] the HM-JACK appears to be useful testing analyser in terms of routine practice.

 Nara Y. et al (1999) Kiki Shiyaku (Instrument Reagent)