Abbott AEROSET - Linearity Verifiers (80-5953-00, 2 X 3 Ml)

PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution Assays/Reagents
AEROSET
®
System Troubleshooting Guide 129
94816-107—November 2004
Linearity Verifiers (80-5953-00, 2 x 3 mL)
The Linearity Verifiers are Genzyme products and should be
ordered from Genzyme. Verifiers are stable for 7 days when
stored at 2 to 8°C.
Perform the following steps to confirm linearity of the assay.
1. Reconstitute with 3 mL of DI water, swirl, and let stand for
30 to 60 minutes at room temperature. Invert gently and
let stand for an additional 15 minutes.
2. Make admixtures* from the high and low level verifiers,
and run in quadruplicate.
* Admixtures are additional levels created by diluting the
high and low level verifiers. Refer to the following table.
3. Graph the admixtures using 40% as the theoretical value.
The 40% dilution is considered truth to calculate the
remaining admixture’s theoretical values.
a. Calculate the mean value of the replicates for each
dilution.
b. Calculate the theoretical value of each sample using
the value determined for the 40% sample.
c. Plot the results: theoretical (x axis), mean values of
the samples (y axis).
d. Inspect the plot for linearity and make a visual
determination as to the acceptable reportable range.
e. Calculate the %recovery for each sample:
%recovery = (mean result/theoretical result) × 100.
f. Each sample value should be within ± 10% of the
theoretical value. If not, evaluate the clinical
significance.
% Sample
Volume High
Verifier (µL)
Volume Low
Verifier (µL)
00500
20 100 400
40 200 300
60 300 200
80 400 100
100 500 0