OPTIMedical OPTI CCA-TS, Operator'S Manual, Page: 229 / 271

Operator’s Manual – OPTI CCA-TS Lac-3
ANALYTES
LACTATE
Chemical Test level
Concentration
d max Lactate Level
mM
Interference
Intralipid 1% 0.2mM
2 NO
5 NO
Methylene Blue 0.125 mM 0.2mM
2 0.6 mM
5 1.1 mM
Sodium Chloride 20 mM 0.2mM
2 NO
5 NO
Additional interferences were found with the use of Sodium Fluoride (NaF) collection tubes.
Heparin salts are the only recommended anti-coagulants acceptable for use on the B-Lac cassette.
Reproducibility
Controls
Within-Run (Swr) and Total (ST) Precision were determined from 2 runs per day with 2 replicates per run
over a period of 20 days following the CLSI guideline EP5-A2. Typical results for three different lots of
B-Lac cassettes are shown below. (Lactate values in mmol/L).
Material mean Lot 1 Lot 2 Lot 3
OPTI CHECK
(aqueous control solution)
Swr ST Swr ST Swr ST
Level 1 0.89 0.12 0.14 0.09 0.1 0.06 0.09
Level 2 2.39 0.17 0.19 0.16 0.18 0.09 0.13
Level 3 4.20 0.28 0.31 0.17 0.22 0.22 0.26
Whole Blood
Within-Run precision in whole blood samples was evaluated at three different lactate concentrations using
multiple instruments and multiple cassette lots.
Lactate in Whole Blood
Level 1 Level 2 Level 3
Average 2.81 4.03 5.44
St. Dev 0.16 0.18 0.32
%CV 5.6% 4.6% 5.9%
n 12 12 12