Abbott i-STAT 1 System Manual page 530

Method Comparison: i-STAT vs Abbott Architect
i-STAT (Whole Blood) vs
Architect (Fresh Plasma)
n
Slope
Intercept
Sy.x
Syy
Sxx
r
Xmin
Xmax
Analytical Specificity
The β-hCG method is specific for the beta subunit (free and intact) of human chorionic gonadotropin. The
following were tested and found to have an insignificant effect on the measured β-hCG.
Crossreactant
LH
FSH
TSH
Limit of Quantitation, Limit of Detection, Limit of Blank
The Limit of Quantitation (LOQ), Limit of Detection (LOD), and Limit of Blank (LOB) were all estimated (as
per CLSI guideline EP17-A
Recovery
The dilution linearity of the i-STAT β-hCG test was investigated using heparinized whole blood and
plasma samples derived from three separate donors. For each donor, the original β-hCG negative
sample and a β-hCG spiked sample were prepared. This process yielded three β-hCG positive whole
blood samples that were then assayed in 10 cartridges for each of the three separate i-STAT β-hCG
cartridge lots. These whole blood samples were then diluted using an equal volume of the original
unspiked whole blood and assayed in 10 cartridges from each of three separate i-STAT β-hCG cartridge
lots. From this whole blood data, the β-hCG recovery was calculated.
The plasma derived from these three donors was combined in equal volumes and all pairwise
combinations. These combinations were then assayed on 10 cartridges for each of three separate i-STAT
β-hCG cartridges. The β-hCG recovery was calculated using the average of the 30 results. The %
recoveries are listed in the tables below.
β-hCG
- 4
288
1.01
2.40
0.0084
5.7%
N/A
0.990
8.8
2024.8
Concentration
450 IU/L
300 IU/L
100 mIU/L
) to be below the lower end of the reportable range, 5 IU/L.
14
Art: 730474-01D
(IU/L)
i-STAT (Fresh Plasma) vs
Architect (Fresh Plasma)
287
1.00
-3.21
0.0044
4.0%
2.4%
0.997
7.9
1983.6
Crossreactivity (%)
<10%
<10%
<10%
Rev. Date: 24-Jan-17