Reagent on-board stability study on the new economic respons 910

® clinical analyser
H. Baethies, M. Kiefer, S. Dietel, A. Nadem, S. Caspari, R. Schenk, E. Metzmann, T. Hektor
DiaSys Diagnostic Systems GmbH, Alte Strasse 9, 65558 Holzheim, Germany, www.diasys-diagnostics.com
Introduction Results Creatinine Jaffé
sample near cut-off; no compensation
Materials & Methods
The DiaSys respons®910 system is a compact, economic, Table 1 summarizes the results of the on-board stability 1,80

1,70
On-board and calibration stability tests for 28 assays have
fully automated bench-top clinical chemistry analyser study under non-refrigerated conditions vs. refrigerated been carried out on two respons®910 systems in parallel.

creatinine [mg/dL]
1,60

1,50

designed for small to mid-size workloads. storage. Although the temperature range in the non-cooled 1,40
recovery
All reagents, calibrators and controls were commercial
reagent compartment was from 25°C to 30°C the notable available products of DiaSys Diagnostic Systems GmbH.
1,30

Key features are the simultaneous 12 wavelength detection

target
1,20 lower limit (-10%)

and the economic long-term on-board stabilities of reagents on-board stabilities for Creatinine Jaffé and Cholesterol 1,10

1,00
upper limit
(+10%)
recalibration Three different levels, one within normal range, one patholo-
on a non-refrigerated reagent rotor tray. reagent are shown in Figures 2 - 5. In particular the 0 5 10 15

on-board time [days]

20 25
gical sample and one near the upper linearity limit of the
Creatinine Jaffé reagent showed a 5-fold extended Figure 2: Creatinine sample near cut-off assay, were measured in each assay at least twice a week
on-board and nearly a doubled calibration stability over a total period of nine weeks. The sample at the upper li-
Creatinine Jaffé
compared to the Hitachi 911 refrigerated system. sample near upper linearity limit; no compensation nearity limit verifies the validity of the measuring range.
19,0

confidence respons ®910 Hitachi 911 18,0 Acceptance criterion was the recovery of each assigned

creatinine [mg/dL]
limits non-cooled reagent storage cooled reagent storage 17,0

16,0 target value within ±10% limits. For parameters where the
assay ± x% on-board calibration on-board calibration
Guidelines of the German Federal Medical Society [3], re-
15,0 recovery

AMY 10 4w 2w 4w 4w 14,0 target

quires deviations below ±10% limits, these criteria were

lower limit (-10%)
13,0
ALP 10 3w 7d 8d 8d 12,0
upper limit
(+10%)

ALT 10 4w 4w 4w 4w
recalibration

ALT + p5p 10
11,0
used for result assessment.
4w 4w 6d 6d 0 5 10 15 20 25

AST 10 6w 6w 4w 4w
on-board time [days]
In case the result missed the target criteria, the assay was
AST + p5p 10 10 d 10 d 6d 6d Figure 3: Creatinine sample near upper linearity limit re-calibrated. If the limit was failed again after re-calibration,
Ca P 6 10 d 10 d 8w 8w
CHOL 7 8w 4w 4w 4w Cholesterol the study for that dedicated clinical parameter was
sample within reference range
CK NAC 10 6w 3w 4w 4w 170
terminated.
CK-MB 10 4w 1w 6w 6w

cholesterol [mg/dL]
160

CREA (Jaffé) 10 3w 1w 4d 4d
Conclusion
150

CRP 10 4w 1w 4w 4w
140 recovery
DBIL 10 6w 3w 4w 4w
Figure 1: DiaSys respons®910 target
The in-use stability under non-refrigerated conditions was
FE 10 6w 1w 6w 6w 130 lower limit (-7%)

GGT 10 2w 1w 4w 4w 120
upper limit
(+7%) shown for a panel of representative clinical assays. All rea-
To demonstrate the long-term on-board stability a panel of
0 10 20 30 40 50 60
GLUC (HK) 10 6w 6w 4w 4w on-board time [days] gents on board of the system showed calibration and in-use
HbA1c 10 4w 10 d 8w 8w
28 clinical IVD reagents was evaluated. The panel included HCO3 10 3w 2w 3w 3w Figure 4: Cholesterol sample within reference range stabilities comparable to modern analysers with refrigerated
tests sensitive to environmental factors, like atmospheric HDL 10 4w 2w 4w 4w reagent compartments. It was demonstrated that the
Cholesterol
LDH 9 5w 4d 10 d 5d
oxygene, carbon-dioxide, temperature or evaporation. sample near upper linearity limit respons®910 is an economic, robust system, which meets
LDL 10 4w 10 d 4w 4w 790

LPS 10 6w 1w 6w 6w
765
the demands of a state-of-the-art clinical laboratory.

cholesterol [mg/dL]
The Creatinine Jaffé method is known to the laboratory
740
PO3 9 3w 1w 4w 4w 715

for short on-board stability. Cholesterol on the other hand TBIL 10 4W 3d 4w 4w 690
665 recovery
References
TP 6 10 d 7d 10 d 7d
is known to be a very stable reagent. Therefore these two TRIG 9 4w 7d 4w 2w
640
615
target
lower limit (-7%) [[1] La Penberthy. A Users Guide to Statistics in Clinical Chemistry. J Clin Biochem Revs
(1986);7:3947.
reagents were used as benchmark for the stability under
upper limit
UA (TOOS) 10 6w 3w 6w 6w 590 (+7%)

0 10 20 30 40 50 60 [2] CLSI. Evaluation of Stability of In Vitro Diagnostic Reagents; approved guideline.

UREA 10 4w 7d 6w 6w
non-cooled reagent storage conditions on the respons®910 on-board time [days] CLSI Document EP25-A. Wayne (PA): CLSI; 2009.
Table 1: Summary of the on-board stability study results. [3] „Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer
instrument. Legend: w = weeks; d = days Figure 5: Cholesterol sample near upper linearity limit Untersuchungen“. Deutsches Ärzteblatt (2008); Jg. 105:Heft 7.