PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
Assays/Reagents
AEROSET
®
System Troubleshooting Guide
121
94816-107—November 2004
C-Reactive Protein
Before troubleshooting the CRP assay, ensure the assay
parameters were configured correctly. Do not install the CRP
assay using assay parameters on the Import Disk—Serum
Proteins Version 1.0.
Standard Material Recovery
Recovery accuracy results of the standard material are
summarized in the following table.
Assay
Standard
Material
N
Units
Expected
Value
Recovered
(Mean) Value
%Recovery
CRP
(LN 8G65)
CRM 470
4
IU/mL
203.72
213.14
104.62
4
IU/mL
105.73
115.62
109.35
4
IU/mL
50.93
52.47
103.02
4
IU/mL
26.43
27.19
102.87
Frequently Asked Questions (FAQ)
Question
Answer
The LOQ claim is 0.50 mg/dL in the CRP
package insert. The insert also states that a
study was performed on the AEROSET and
ARCHITECT
®
c
8000
®
Systems, which resulted
in an LOQ of 0.25 mg/dL. Where did the LOQ
claim of 0.50 mg/dL originate?
The LOQ study yielded representative data of
0.25 mg/dL (worst case result observed). The
claim of 0.50 mg/dL is the Product
Requirement, minimum acceptable
performance, which was determined before
performing the LOQ study.
Product claims are based on product
requirements which Abbott Laboratories
determines from literature, customer
feedback, and other sources of information.
Actual product performance “typical results”
may perform better than the claim.
In the package insert, why is there is a serum
reference range but not a plasma reference
range?
The reference range study was performed with
only serum specimens to confirm the
literature reference, which also used only
serum specimens.
A separate reference study with plasma
specimens was not performed.