Arkray ADAMS A1c User Manual

6.3 Performance Characteristics
HA-8190V 6-15
4) Interference
5) Investigation of Variant Hb
Variant mode
None of the samples containing HbS or HbC that were measured affected the HbA1c measurement result.
All samples containing HbE or HbD that were measured were detected correctly as samples that include
HbE or HbD.
6) Method comparison
Variant mode
Fast mode
*ADAMS A1c HA-HA-8182 measurement
7) Matrix comparison
All available anticoagulants had no effect on the measurements.
6.3.2 Clinical Performance
Variant mode
Fast mode
Substance Test concentration with
no significant interference
Carbamylated Hb (Sodium Cyanate)
Aldehyde Hb (Acetaldehyde)
Labile A1c (Glucose)
Bilirubin, conjugated
Bilirubin, unconjugated
Ascorbic Acid
7 mg/dL
10 mg/dL
500 mg/dL
100 mg/dL
100 mg/dL
200 mg/dL
Correlation coefficient
with reference method
*
0.999
Correlation coefficient
with reference method
*
1.000
Positive percent agreement Negative percent agreement Overall percent agreement
100% 97% 99%
vs. ADAMS A1c HA-8180V measurement
Positive percent agreement Negative percent agreement Overall percent agreement
100% 100% 100%
vs. ADAMS A1c HA-8180V measurement
REFERENCE:
The clinical cutoff point for diagnosis of diabetes, 6.5% was used for the determination of Positive/Negative.
New WHO criteria on use of Glycated Haemoglobin (HbA1c) in the Diagnosis of Diabetes Mellitus (2011)

Arkray ADAMS A1c Specifications

General

Brand	Arkray
Model	ADAMS A1c
Category	Measuring Instruments
Language	English