Clin Chem Lab Med 2020; aop
Carolyn Piggott*, Magdalen R. R. Carroll, Cerin John, Shane O’Driscoll and Sally C. Benton
Analytical evaluation of four faecal
immunochemistry tests for haemoglobin
https://doi.org/10.1515/cclm-2020-0251
Received March 4, 2020; accepted June 29, 2020; published online
xxx
Abstract
Background: Faecal immunochemical tests (FIT) for hae-
moglobin (Hb) are being used in the investigation of
colorectal cancer. These tests use antibodies raised to the
globin moiety of human Hb. Here, four automated quan-
titative FIT systems (HM-JACKarc, NS-Prime, OC-Sensor
PLEDIA and SENTiFIT 270) are evaluated analytically to
confirm whether the performance of the systems meet the
manufacturers’ claims.
Methods: Assessment of the analytical performance of the
FIT systems was undertaken using Hb lysates, real patient
samples and external quality assessment (EQA) samples.
This analytical assessment focused on detection charac-
teristics, imprecision, linearity, prozone effect, recovery
and carryover.
Results: All four methods demonstrated good analytical
performance, with acceptable within- and between-run
imprecision, good recovery of f-Hb and limited carryover of
samples. They also all show good linearity across the range
of concentrations tested. The results of EQA samples
showed different variations from the target values (−52 to
45%), due to the absence of standardisation across the
different methods.
*Corresponding author: Carolyn Piggott, NHS Bowel Cancer
Screening Programme – Southern Hub, Royal Surrey County Hospital,
20 Priestley Road, Surrey Research Park, Guildford, GU2 7YS, UK;
Berkshire and Surrey Pathology Services, Royal Surrey County
Hospital, Guildford, England, UK, E-mail: carolyn.piggott@nhs.net.
https://orcid.org/0000-0002-6343-6202
Magdalen R. R. Carroll, Cerin John, Shane O’Driscoll and Sally C.
Benton: NHS Bowel Cancer Screening Programme Southern Hub,
Royal Surrey County Hospital, Guildford, England, UK; Berkshire and
Surrey Pathology Services, Royal Surrey County Hospital, Guildford,
England, UK, E-mail: romanyrowan@gmail.com (M.R.R. Carroll),
cerin.john@nhs.net (C. John), sodriscoll@nhs.net (S. O’Driscoll),
sally.benton@nhs.net (S.C. Benton). https://orcid.org/0000-0001-
6886-5631 (M.R.R. Carroll). https://orcid.org/0000-0002-7577-6503
(C. John). https://orcid.org/0000-0002-8693-3658 (S. O’Driscoll).
https://orcid.org/0000-0001-9230-9088 (S.C. Benton)
Conclusions: All four systems are fit for purpose and have
an analytical performance as documented by their
manufacturers.
Keywords: analytical evaluation; colorectal cancer; faecal
immunochemical test; FIT.
Introduction
The quantitative faecal immunochemical test for haemo-
globin (FIT) measures the concentration of human blood in
faeces using polyclonal antibodies raised against the
globin moiety of human haemoglobin (Hb). These tests are
being used worldwide for both screening of asymptomatic
individuals [1] and to aid the assessment of patients with
low risk symptoms [2]. Although these tests are not
currently widely used in the diagnosis and monitoring of
inflammatory bowel diseases such as Crohn’s disease and
ulcerative colitis, there is potential for this use and studies
are being carried out [3].
FIT has superseded the use of guaiac faecal occult
blood testing (gFOBT). FIT offers advantages over gFOBT
which include quantitative examination with the option to
choose the cut-off for positive results, with low cut-offs for
the triage of symptomatic patients, and higher cut-offs for
asymptomatic participants in screening programmes, the
antibodies are specific to human Hb, and the examination
can be carried out on semi-automated instruments. One FIT
collection device requiring a single faecal sample is
acceptable for screening and to determine the need for a
colonoscopy in symptomatic patients [1–3]. FIT uses a
simpler and more attractive sampling technique than that
used by gFOBT; it allows the positivity rate to be adjusted to
meet local colonoscopy resources; and the Hb concentra-
tion has the potential to be incorporated into a multivariate
risk score to enable a higher sensitivity for cancer or
advanced adenoma [4, 5].
In this study four quantitative FIT laboratory analysers
and their appropriate materials have been evaluated
analytically to confirm whether the systems’ performance
meet manufacturers’ claims. These are the HM-JACKarc
(Kyowa Medex Co. Ltd/Hitachi Chemical Diagnostics
Systems, Tokyo, Japan); NS-Prime (Alfresa Pharma
2 Piggott et al.: Evaluation of four FIT
Corporation, Osaka, Japan); OC-Sensor PLEDIA (Eiken
Chemical Co. Ltd, Tokyo, Japan) and the SENTiFIT 270
(Sentinel Diagnostics SpA, Milan, Italy). These systems
were selected as, in our opinion, they were potentially
suitable for processing samples for screening programmes
due to their throughput and ease of use. All analysers and
their materials were provided free of charge.
The four FIT systems studied are bench top analysers
which utilise gold- (NS-Prime) or latex-particle aggluti-
nation (HM-JACKarc, OC-Sensor PLEDIA and SENTiFIT
270/FOB Gold), and turbidimetric analysis to determine
the concentration of Hb present in faecal samples pro-
vided for examination [6]. Three of the analysers
(NS-Prime, OC-Sensor PLEDIA and SENTiFIT 270) use
reusable cuvettes which are washed between each sample,
whereas the HM-JACKarc uses single use cuvettes, dis-
carding the cuvettes after each test.
In 2013 an evaluation of analysers (HM-JACKarc,
NS-Plus, OC-Sensor DIANA and Biomajesty) and their
associated materials and collection devices available at
the time, and suitable for use in national screening pro-
grammes, was carried out [7]. Since then the NS-Plus and
OC-SENSOR DIANA analysers have been updated, with
the HM-JACKarc remaining unchanged; to our knowledge
the methodology has remained unchanged for all three.
The NS-Prime and the OC-Sensor PLEDIA have larger
sample loading and reagent capacities and the user
software programmes are simplified. This evaluation has
examined the SENTiFIT 270 instead of the Biomajesty,
which both use the Sentinel Diagnostics FOB Gold
method, although a different calibrator has been used in
this evaluation.
All four analysers have associated specimen collection
devices provided by the manufacturers, which are used
by participants to collect either 2 (HM-JACKarc) or 10 mg
(NS-Prime, OC-Sensor PLEDIA and SENTiFIT 270) of
faeces [7]. The devices are then sent to laboratories for
examination.
To our knowledge, there is currently no peer-
reviewed independent comprehensive analytical evalu-
ation of these quantitative FIT systems. This is despite
their increasing use in screening programmes and
symptomatic populations.
The aim of this study was to carry out an analytical
evaluation of four automated quantitative FIT systems.
Methods
The study followed the World Endoscopy Organisation (WEO) faecal
immunochemical tests for haemoglobin evaluation reporting (FITTER)
checklist [8].
Materials
Assessment of the analytical performance across the FIT systems was
undertaken using Hb lysates, anonymised patient samples and EQA
materials.
Hb lysates were prepared from venous blood collected into
potassium-EDTA blood collection tubes (VACUETTE, supplied by
Berkshire and Surrey Pathology Services) and included a final 1-in-2
dilution in physiological saline. The Hb concentration of each diluted
lysate was determined by measurement as part of the full blood count
on an ADVIA 2120 (Siemens Healthcare Ltd. Frimley, UK). The lysate
samples were frozen at −20 °C until used. Further dilutions were made
in manufacturer specific diluent.
Samples were aliquoted into analyser cups, with the number of
cups needed for each assessment depending on the maximum
number of replicates that could be set for each system (number of
replicates: HM-JACKarc up to 3, NS-Prime up to 9, OC-Sensor PLEDIA
up to 10; SENTiFIT 270 up to 10). EQA samples were loaded into, and
sampled directly from, the FIT sampling devices. Where samples
were measured multiple times on any single day, they were
measured in a single run. Where samples were measured on more
than one day, new aliquots were used for each day, and if taken
multiple times from the same original sample, this was mixed
between removal of the aliquots.
Detectability characteristics
Detectability characteristics were assessed as recommended by Fraser
and Benton [9] according to the CLSI EP17-A2 protocol [10] through
determination of limit of blank (LoB), limit of quantitation (LoQ) and
limit of detection (LoD):
LoB: “the highest measurement result that is likely to be observed
(with stated probability) for a blank sample” [10]; 20 blank collection
devices were analysed and the following calculation used to deter-
mine the value: LoB=mean [blank] + 1.645(SD [blank]).
LoQ: “the lowest amount of a measurand in a material that can
be quantitatively determined with stated accuracy, under stated
experimental conditions” [10]. A range of Hb dilutions, around the
LoQ provided by the manufacturer (Table 1), was created for each
FIT system by using samples naturally positive and negative for f-
Hb. The samples were 2–5 days old and collected from participants
in a multi-sampling study (in which each participant was sent four
different collection devices; samples were returned by post and
refrigerated as they arrived). The contents of the appropriate de-
vices, ranging from three to seven samples per system, were pooled
together, and the concentration of the pool determined by exami-
nation on the relevant analyser, within five days of the samples
being collected. This was used to create a concentration gradient
from 0 to 20 µg Hb/g faeces for each FIT system; each sample was
measured 10 times. The SD and CV were determined for each con-
centration. The LoQ was taken to be the concentration at which the
measured CV was below 10%.
LoD: “the lowest concentration of measurand which can
consistently be detected” [10] was determined using a sample from a
participant in the multi-sampling study, just below the LoQ concen-
tration; this sample was analysed 20 times and the following calcu-
lation was used to determine the value: LoD=LoB + 1.645(SD [low
concentration sample]).
 Piggott et al.: Evaluation of four FIT 3

Table : Limit of blank (LoB, n=), limit of detection (LoD, n=) and limit of quantitation (LoQ, n= each concentration) of all four faecal
immunochemical test (FIT) systems. NA: Not available. LoQ range of concentrations tested: HM-JACKarc – µg/g, NS-Prime – µg/g,
OC-Sensor PLEDIA – µg/g, SENTiFIT  – µg/g.

FIT system LoB (μg Hb/g faeces) LoD (μg Hb/g faeces) LoQ (μg Hb/g faeces)

Manufacturer quoted Study results Manufacturer quoted Study results Manufacturer quoted Study results

HM-JACKarc NA  NA   
NS-PRIME NA     
OC-Sensor PLEDIA NA  NA   
SENTiFIT       

Imprecision Hook/prozone

Between-run imprecision was assessed by measuring three replicates
of each concentration of Hb lysate diluted in manufacturers’ buffer,
measured on five consecutive days, using separate aliquots stored at
4–8 °C for each day. The number of concentrations was determined by
each manufacturer, where they had carried out a similar study, and we
aimed to replicate their concentrations (see Table 2 for concentra-
tions). The F-test was used to determine if the SD of each set of results
was significantly different to the manufacturer’s SD.
Within-run imprecision was assessed by measuring control so-
lutions provided by the manufacturers 10 times each in one run; the
mean, SD and CV were calculated.
The analytical reaction was tested for the presence of the hook/pro-
zone effect, where immunoassays may give erroneously low values for
samples of extremely high concentrations of analyte. Eight samples
for each system were prepared using Hb lysate solution diluted in
manufacturer-specific collection device diluent to give concentrations
above the upper limit of measurement range of the method (HM-
JACKarc: 6,200–100,000 µg Hb/g, NS Prime: 600–78,000 µg Hb/g OC
SENSOR: 1,000–137,000 µg Hb/g, FOB Gold: 664–85,000 µg Hb/g)
These samples were measured in duplicate to check whether erro-
neous results were blocked and reported with a clear error message.

Linearity
The measurement range of the assay was assessed using between 14
and 16 dilutions of the Hb lysate in manufacturer-specific collection
device diluent. The concentrations studied covered the analytical
range of each system (measurement ranges: HM-JACKarc 7–400 µg
Hb/g faeces, NS-Prime 10–240 µg Hb/g faeces, OC-Sensor PLEDIA 10–
200 µg Hb/g faeces, SENTiFIT 270 3–170 µg Hb/g faeces). Each sample
was analysed in duplicate, and the R2 value calculated.
Carryover
Sample carryover was assessed using the protocol described by
Broughton et al. [11]. A Hb lysate solution of high Hb concentration
and a solution of low Hb concentration (b) were prepared in manu-
facturer specific collection device diluent in sample cups
(HM-JACKarc: 210 and 30 µg Hb/g, NS Prime: 236 and 10 µg Hb/g, OC
SENSOR: 96 and 15 µg Hb/g, FOB Gold: 53 and 12 µg Hb/g). Three
aliquots of each solution were measured, one set following the other.
This process was repeated 10 times. The carryover factor (k) was

Table : Between-run imprecision of haemoglobin (Hb) measured with four faecal immunochemical test (FIT) systems (n= for each
material); p-value calculated using F test.

FIT system Manufacturers’ results Study between-run imprecision p-value

Mean Hb (µg/g) SD Hb (µg/g) CV (%) Mean Hb (µg/g) SD Hb (µg/g) CV (%)

HMJACK-arc  . .  . . .

 . .  . .
 . .  . .
NS-Prime  . .  . . .
 . .  . .
 . .  . .
 . .  . .
OC-Sensor PLEDIA  . .  . . .
 . .  . .
SENTiFIT   . .  . . .
 . .  . .
 . .  . .
4 Piggott et al.: Evaluation of four FIT

calculated from the equation: k=(b1 − b3)/(a3 − b3), where ‘a’ and ‘b’
are the high and low concentration solutions respectively, and ‘1’ and
‘3’ are the results for the first and third sample respectively.
Recovery
The Hb lysate solution diluted in manufacturer-specific collection device
diluent was prepared at a low but reliably measurable concentration for
each FIT system. Two sets of eight samples were prepared: in one set
small volumes were replaced with high concentration solution (the
relevant FIT system calibrator), and in the other set, identical volumes
were replaced with diluent; no volume replacement exceeded 10% of the
final volume. The samples were measured in duplicate and the recovery
calculated by comparing the expected concentration of Hb in each
sample with the measured concentration of Hb; recovery (%) = (mean of
measured values)/(expected concentration) × 100.
External quality assessment
2 μg Hb/g faeces; the LoDs were equal to or less than 3 μg Hb/
g faeces and the LoQs were 3 μg Hb/g faeces on the NS-Prime
and SENTiFIT 270, 4 μg Hb/g faeces on the HM-JACKarc and
6 μg Hb/g faeces on the OC-Sensor PLEDIA. All results met,
or were lower than the manufacturers’ claims.
Imprecision
The between-run imprecision SDs (Table 2) using diluted
Hb lysate for all concentrations on all FIT systems were not
significantly different (p>0.05) than the manufacturers’
claims.
Control materials were used to assess the within-run
imprecision (Table 3); all FIT systems had CVs within the
manufacturers’ claims and were less than 3%.

The UK National External Quality Assessment Services (UK NEQAS, Linearity

Birmingham, England) provided six EQA samples (faecal-like matrix,
0–120 µg Hb/g faeces) which on receipt were loaded into the relevant All FIT systems showed good linearity (R2 between 0.97 and
sample collection devices before analysis. The amount of loaded
0.99) throughout the ranges tested.
sample covered the grooves or dimples of the sampling devices, with a
slight excess. A slight excess of sample has been shown not to
significantly affect the f-Hb using these same FIT systems [12], as it is Prozone
removed by the internal collar.

All FIT systems detected the prozone appropriately and

Results
Throughout this paper all results are presented as μg Hb/g
faeces in accordance with the WEO FITTER protocol. This
enables direct comparison of the results across the
different FIT systems [8].
Detectability characteristics
The LoB, LoD and LoQ for the four FIT systems using patient
samples from a multi-sampling study are shown in Table 1.
The LoBs for the four FIT systems were equal to or less than
gave adequate error warnings. These either alerted the user
to the need for dilution, or that the sample was too
concentrated for an accurate result to be determined (giv-
ing ‘prozone warnings’). Of the four manufacturers, only
Sentinel include any information on the potential of a
prozone effect, which they state will not occur below
4,845 µg Hb/g faeces.
Carryover
Carryover determined by the Broughton method [11], was
insignificant (k<0.05) on all four FIT systems.

Table : Within-run imprecision of haemoglobin (Hb) measured with four faecal immunochemical test (FIT) systems.

FIT system Manufacturers’ claim for within-run Study within-run imprecision

imprecision
n Mean Hb SD CV Consistent with
(µg Hb/g faeces) (µg Hb/g faeces) (%) claim

HM-JACKarc CV≤% (n=)   . . Yes

  . .
NS-PRIME CV≤% (n unknown)   . . Yes
  . .
OC-Sensor PLEDIA CV % (n=)   . . Yes
  . .
  . .
SENTiFIT  ≤ µg/g CV≤% or SD≤; > µg/g   . . Yes
CV≤% (n=)   . .

Recovery
The HM-JACKarc recovery was 94–100%, the NS-Prime
97–114%, OC-Sensor PLEDIA 93–109%, and SENTiFIT 270
87–99%.
EQA sample comparison
Figure 1 shows the results from the UK NEQAS material.
The HM-JACKarc showed positive bias from the target
values; the OC-Sensor PLEDIA, NS-Prime and the SENTiFIT
270 showed negative bias from the target values.
Discussion
All four methods demonstrated good analytical perfor-
mance, with detectability characteristics (LoB, LoD, LoQ)
meeting or better than the manufacturers' claims, within-
run and between-run imprecision meeting or not signifi-
cantly different than manufacturers' claims, and linearity
R2 values between 0.97 and 0.99. All the systems detected
prozone samples correctly, carryover was insignificant,
and recovery was 87–114%.
Each manufacturer provided details of their own
assessment of their FIT systems and this evaluation was
compared with these claims, all data were in agreement.
The results of the EQA examination (faecal-like matrix
spiked with Hb and loaded into FIT sample collection de-
vices) show that the systems all give different Hb concen-
trations which varied from the expected values (Figure 1,
median values: HM-JACKarc 45%, OC-Sensor PLEDIA –
29%, NS-Prime –30%, SENTiFIT 270 –52%); this is to be
expected because the methods are traceable to different
reference materials.
There have been three previous published studies that
included aspects of the analytical performance included in
this study, although some of these have included the same
Piggott et al.: Evaluation of four FIT 5
reagent method and a different measurement system to this
study.
Within-run and between-run imprecision was studied by
Ahn et al. [13] (OC-Sensor PLEDIA and NS-Prime), Kusaka
et al. [14] (OC-Sensor PLEDIA), Lee et al. [15] (OC-Sensor
Micro and FOB Gold) using QC material or spiked faecal
samples. For within-run imprecision the results all met the
manufacturers’ claims. For between-run imprecision the re-
sults for Ahn et al. [13] and Kusaka et al. [14] met the man-
ufacturers’ claims. The results for Lee et al. [15] showed the
CV%s to be higher than the manufacturer’s claim although it
is unclear if a single sample was stored at 4 °C and remeas-
ured over 17 days, and both methods (OC-Sensor Micro and
FOB Gold) showed a slight but gradual decline in f-Hb over
the same time. The same three studies also included carry-
over, which was found to be insignificant for OC-Sensor
PLEDIA and Micro, and the NS-Prime; for FOB-Gold signifi-
cant carryover was found by Lee et al. [15], although they did
not state which analyser was used in the evaluation. Line-
arity was studied by Ahn et al. [13] and Kusaka et al. [14] and
they both state that linearity was acceptable. LOD, LOQ and
prozone were included by Kusaka et al. [14] and all met the
manufacturer’s claims.
This evaluation does have limitations, most notably to
assess the systems analytically without matrix effect bias;
we used whole blood lysate diluted in manufacturer spe-
cific buffer for some parts of the evaluation. Ideally real
samples would be used and analysed across the four sys-
tems, but there was a limited supply of these and we could
not use them for all parts of the evaluation. Additionally we
have no way of accurately determining the actual original
concentration of Hb within those samples and cannot
determine any bias present [16]. All faecal samples are
unique in composition and have varying degradation rates,
different effects are seen with different samples making
them unsuitable to assess the analytical performance of
systems designed to detect human haemoglobin. The use
of lysate as a surrogate eliminates these effects and allows
Figure 1: Box and whisker plot showing the
bias (%) of UK National External Quality
Assessment Services (UK NEQAS) samples
(faecal-like matrix loaded into sample
collection devices) measured on four faecal
immunochemical test (FIT) systems, against
the EQA scheme target value.
6 Piggott et al.: Evaluation of four FIT
an analytical assessment and comparison of the four FIT
systems. The target concentrations for the imprecision
assessment were chosen to match those quoted by the
manufacturers, although ideally we should have also
included concentrations above and below the commonly
used cut-offs, a negative concentration and the same
samples analysed across all four systems.
Additionally the evaluations for each system were
performed at different times and there were slight differ-
ences in the protocols, particularly for the range of con-
centrations assessed.
Currently, and for future assessments, a reference
standard for faecal Hb is being investigated by the Inter-
national Federation of Clinical Chemistry and Laboratory
Medicine which potentially will increase the accuracy of
such assessments [17].
Conclusions
This evaluation assessed four laboratory FIT systems that
are used for faecal Hb examination in screening and
symptomatic populations. The results confirm that all four
FIT systems perform acceptably when compared with
manufacturers data, and from an analytical perspective, all
are suitable for use.
Acknowledgments: We thank FIT system suppliers
(HM-JACKarc: Alpha Laboratories, Eastleigh, UK;
NS-Prime: originally supplied by Alere Ltd., Chester, UK,
with continuing support from Abbott, Maidenhead, UK,
and Alfresa Pharma, Osaka, Japan; OC-Sensor PLEDIA:
Mast Diagnostics Division, Bootle, UK; SENTiFIT 270:
Sysmex UK Ltd., Milton Keynes, UK) for supplying the
analysers and consumables. We also thank Berkshire and
Surrey Pathology Services (Royal Surrey Foundation Trust,
Guildford, UK) for supplying samples used in the assess-
ment and the United Kingdom National External Quality
Assessment Services (UK NEQAS, Birmingham, UK) for the
external quality assessment (EQA) samples they provided.
Research funding: None declared.
Author contributions: All the authors have accepted
responsibility for the entire content of this submitted
manuscript and approved submission.
Competing interests: None.
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