Bayer HealthCare Rapidlab 800 Blood Glucose Meter User Manual


 
Performance Characteristics EĆ9
Reference Methods
The following reference methods were used for the 800 systems.
Analyte Reference Method
pH IFCC reference method,
*
also referenced by NCCLS document C–27A.
1
pCO
2
and
pO
2
Tonometered whole blood as described in NCCLS document C21–A.
[
Gases used are traceable to NIST Certified Reference Material SRM
series 1701.
Na
+
and
K
+
Method described in NCCLS document C29
12
, which serves as the basis
for the NIST Certified Reference Material SRM 956 using flame
photometry.
Cl
Coulometric reference method. This method, which is embodied in the
Bayer Diagnostics 925, is also used to assign values to NIST Certified
Reference Material SRM 956.
Ca
++
Internal method used.
Glucose The hexokinase/glucose-6-phosphate dehydrogenase method described
in NCCLS document RS1–A.
]
Lactate LD Manual Assay
tHb Cyanmethemoglobin Reference Method per National Committee for
Clinical Laboratory Standards (NCCLS), approved reference procedure
k
using Cary 4 Spectrophotometer.
FO
2
Hb Tonometry, where whole blood samples are tonometered with
95% O
2
, 5% CO
2
.
FHHb Tonometry, where whole blood samples are tonometered with
95% N
2
, and 5% CO
2
.
FCOHb Gas Chromatography
w
for COHb 15% and Ishizawa
#
method using a
Cary 4 Spectrophotometer for COHb 15%
FMetHb
Modified Evelyn–Malloy
37
method utilizing a Cary 4 Spectrophotometer.
* International Federation of Clinical Chemistry. Reference method (1986) for pH measurement in blood.
IFCC 1987/3.
[
National Committee for Clinical Laboratory Standards. Performance characteristics for devices measuring
PO
2
and PCO
2
in blood samples; Approved Standard; NCCLS Document C21–A; (Vol 12, No. 3);
March 1992.
]
National Committee for Clinical Laboratory Standards. Glucose; Approved Summary of Methods and
Materials; NRSCL Document RS1–A; 1998.
w
Vreman, H.J., Kwong, L.K., and Stevenson, D.K., Carbon Monoxide in Blood: an Improved Microliter
Blood-Sample Collection System, with Rapid Analysis by Gas Chromatography, Clin. Chem.30, (1382 -
1386) 1984.
k
National Committee for Clinical Laboratory Standards. Reference and Selected Procedures for the
Quantitative Determination of Hemoglobin in Blood – Second Edition; Approved Standard;
NCCLS Document H15–A; (Vol 14, No. 6); May 1994.
# Ishizawa F. A Study on the Spectrophotometric Determination of Carboxyhemoglobin in Blood —
Isobestic Point Method. Jpn J Legal Med 1981, 35(3), 191–200.