Point-of-care testing for the

analysis
of lipid panels:
primary care diagnostic technology update
IMPORTANCE
-Cardiovascular disease (CVD) is the main
cause of death in the UK, accounting for
over 180 000 deaths in 00!" 1 in # of all
deaths ($$$%heartstats%org)%
&'ipid lo$ering
therapy (usually a statin) is used in all
patients $ith a history of cardiovascular
disease and lipid tests are monitored
annually%
&(ssessment of CVD ris) for
primary prevention is recommended *y the
National Institute for ealth and Clinical
E!cellence for all patients over the age of
+0 years and includes lipidmeasurement%
"ETAI#$ O% TECNO#O&'
&,$o point&of&care Cholesterol -eference
.ethod 'a*oratory /et$or) certi0ed
devices are availa*le in the UK to measure
total and high density lipoprotein (1D')
cholesterol"
1( Cholestech #")* $yste+ ((lere, UK)%
2everal test cassettes are availa*le that
perform one or more of" total cholesterol
(%341%!mmol5l), 1D' (0%+4%3 mmol5l),
triglycerides (0%647%#mmol5l), total
cholesterol51D' ratio, estimate of lo$
density lipoprotein ('D'), and very lo$
density lipoprotein (V'D'), as $ell as
glucose%
% Professional CardioChe, PA -8olymer
,echnology 2ystems, 9nc%, 9ndiana, U2:
;1- 8harmaceuticals 'td%, /uneaton,
UK)% 1andheld device that performs a
range of tests depending on the test strip
selected" lipid panel and single testing for
glucose, )etone, total cholesterol
(%3410%#mmol5l),1D'cholesterol (0%34%
mmol5l), triglycerides (1%#41%8mmol5l),
and calculated 'D' cholesterol%
&.easurements are ta)en from a
.ngerstic, /lood sa+ple applied to a
cassette or strip, that is inserted into a
reader, and results are availa*le in
46minutes%
PATIENT &RO0P AN" 0$E
< 8atients re=uiring primary prevention of
cardiovascular disease%
< .anagement of patients$ith pre&e>isting
cardiovascular disease%
< /12 1ealth Chec) for adults aged
+047+ years%
< 8atients $ith a history of familial
hypercholesterolae+ia(
A"1ANTA&E$ O1ER E)I$TIN&
TECNO#O&'
&-e=uiring less than 2 +inutes to perfor+,
cholesterol and triglycerides tests can *e
carried out during the consultation for the
screening and diagnosis of
hypercholesterolaemia, as $ell as CVD ris)
assessment, and the long&term monitoring
of patients already on treatment% 8atients
could *e given their results immediately,
providing more accurate categorisation in
the ?-92K@ ($$$%=ris)%org) or Aramingham
($$$%framinghamheartstudy%org) ris)
scores and allo$ appropriate management
decisions%
PRE1IO0$ RE$EARC
(ccuracy compared to e>isting technology
,he CardioChe) and Cholestech 'DB
devices $ere evaluated *y the UK /12
8urchasing and 2upply (gency in 006%1 Aor
CardioChe), comparing 103 patientsC
samples $ith la*oratory results gave
correlation coeDcients of 3(45 for total
cholesterol -coe6cient of variation 7C18 T
9:;<= 3(>? for "# cholesterol -C1 T ::;<=
and 3(@4 for triglycerides -C1 T 9?;<( %or
Cholestech= co+paring 99@ patientsA
sa+ples Bith la/oratory analysis= the
correlation coe6cients Bere 3(@> for total
cholesterol -C1 T 2;<= and 3(@2 for "# (CV
E 6410F)%
,he accuracy of Cholestech 'DB
measurements of total cholesterol (,C),
calculated lo$&density lipoprotein
cholesterol ('D'&C), high&density
lipoprotein cholesterol (1D'&C), and
triglycerides $as compared to la*oratory analyses, giving correlations of 0%!1, 0%88,
0%77, and 0%!#, respectively (all 8G0%01)% (
study of point&of&care testing (8HC,) in
9reland using Cholestech 'DB validated the
use of this device%# 1o$ever, one study of
the accuracy of Cholestech in
hyperlipidemic individuals over the age of 70
sho$ed that the porta*le measurements
systematically overestimated triglycerides
(0%# g5': 8G0%001) and 1D'&C (0%016 g5': 8
E 0%0#), $hile 'D'&C concentrations $ere
underestimated (0%0+# g5': 8 E 0%0+3)%+
( study comparing CardioChe) 8( and
Cholestech 'DB $ith a standard venous
*lood sample tested in a la*oratory, sho$ed
that the Cholestech 'DB analyser
demonstrated slightly *etter reproduci*ility
than the CardioChe) 8( analyser $hen
compared $ith la*oratory gold standard
analysis: ho$ever, the study $as limited *y
the small sample siIe (n E #+) $ith no
)no$n ris) factors,6 and did not prove
superior accuracy of either device% 9n a
comparative study of 100 samples,
correlation coeDcients *et$een the 8HC,
and la*oratory methods $ere J0%! for
Cholestech and J0%8+ CardioChe)%3 ,his
translates into machines that are fairly
accurate% 1o$ever, at levels near decision
thresholds of diagnosis and treatment, the
machines may overestimate triglycerides
and 1D', and underestimate 'D'%
9mpact compared to e>isting technology
( recent (ustralian multicentre cluster
randomised controlled trial of 8HC, in K8
practices involving patients $ith esta*lished
hyperlipidae+ia= esta/lished type 9 or type :
dia/etes= or ta,ing anticoagulant therapy=
sho$ed that for all tests e>cept 9/-
(international normalised ratio) and 1D'
cholesterol, the 8HC, had the same clinical
eLectiveness as pathology la*oratory
testing%7 ,he same study also sho$ed that
access to 8HC, $as associated $ith the
same or *etter medication adherence%8 (
survey of K8s and patients sho$ed that
cholesterol 8HC, $as strongly supported,
citing factors such as convenience and
eDciency%! ( randomised trial of pharmacy*ased
cholesterol ris) management
involving 6+ community pharmacies and
376 patients at high ris) for cardiovascular
events sho$ed that in 67F of intervention
patients versus #1F in usual care,10 the
primary endpoint of a complete fasting
cholesterol panel *y the K8, or prescription
of ne$ cholesterol&lo$ering medication or
an increase in dosage $as reached%
Cost&eLectiveness and economic impact
A rando+ised controlled trial Bith ?@54
patients in 2C general practices across
Australia=99 found a non&signi0cant increase
in per&patient direct costs for the 8HC,
group, although there $ere also cost
savings in terms of patient and familyincurred
costs (travel and time see)ing
health care)% ,he main cost contri*utors
$ere due to increased pharmaceutical
costs and hospitalisations (not statistically
signi0cant) in the 8HC, group% ,he study is
limited *y reporting its measure of
eLectiveness in terms of Mproportion of
patients $ithin the therapeutic rangeC,
rather than life&years or ?('Ns% 8HC, is
more eLective than standard la*oratory
testing *ut also more costly: the
incremental cost&eLectiveness ratio (in
terms of incremental cost per patient
maintained $ithin the therapeutic range) is
reported to *e O(U2 10 08 (P+637),
re=uiring a decision as to $hether this cost
is Qusti0ed in terms of the value placed on
the measure of eLectiveness used in this
analysis%
(U2 revie$of8HC, cholesterolmonitors
descri*ed their possi*le role in
pharmacies1 and suggests that they oLer
several potential advantages including ease
of use, porta*ility, increased patient access,
lo$ cost, fe$er physician or la*oratory
visits, and instant results%
Aurther research is re=uired to determine
$hether it provides a cost&eLective
alternative to standard la*oratory practice
in the UK%