Abstract
Background: A new automated immunoassay low-mid volume (≤ 250 immunoassays/day) chemiluminescent analyzer, Abbott Architect i1000 SR, was evaluated by seven laboratories around the world (4 in Europe, one each in Canada, Japan, and the U.S.A.) to demonstrate equivalent performance for key operating characteristics (e.g., precision, turn around time, limit of detection, functional sensitivity, and linearity). Methods: The laboratories followed standard protocols to assess precision, limit of detection (LoD), functional sensitivity, assay linearity, method comparison, and sample carryover. Turn around time for three stat assays (B-hCG, BNP, and CK-MB) and the time required to complete workloads of 50 and 100 tests with a mixture of 75% routine tests and 25% stat tests was also evaluated. Results: Total precision was typically <5% CV for nine immunoassays. Analytical performance met design goals and demonstrated equivalency to package insert data for assays on market and in use for an existing high volume immunoassay system. Stat turn around times were consistent with the fixed analytical time of 15.6 minutes and met the expectations of the laboratories. Measured test throughput ranged from 47 - 54 tests per hour and demonstrated that the analyzer was fit for the intended purpose of supporting a laboratory that performs ≤ 250 immunoassays per day. Conclusions: A multisite, international analyzer familiarization study is a practical means of confirming that a new instrument meets both a manufacturer's design specifications and users' real world expectations and provides a pragmatic test for the system. The experience of investigators at seven sites around the world indicates that a new fully automated chemiluminescent system is suitable for use.
| Original language | English |
|---|---|
| Pages (from-to) | 363-370 |
| Number of pages | 8 |
| Journal | Clinical Laboratory |
| Volume | 55 |
| Issue number | 9-10 |
| Publication status | Published - 2009 |
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Keywords
- Chemiluminescent immunoassay
- Immunoassay
- Immunoassay analyzer
- Instrument evaluation
ASJC Scopus subject areas
- Biochemistry, Genetics and Molecular Biology(all)
Cite this
Multi-site, multi-country evaluation of analytical and operational performance of a low-mid volume chemiluminescent immunoassay analyzer. / De Keijzer, M. H.; Perkins, S.; Motta, V.; Morelli, D.; Cristol, J. P.; Dupuy, A. M.; Hong, Y.; Watanabe, S.; Waerdt, C.; Grunewald, R. W.
In: Clinical Laboratory, Vol. 55, No. 9-10, 2009, p. 363-370.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Multi-site, multi-country evaluation of analytical and operational performance of a low-mid volume chemiluminescent immunoassay analyzer
AU - De Keijzer, M. H.
AU - Perkins, S.
AU - Motta, V.
AU - Morelli, D.
AU - Cristol, J. P.
AU - Dupuy, A. M.
AU - Hong, Y.
AU - Watanabe, S.
AU - Waerdt, C.
AU - Grunewald, R. W.
PY - 2009
Y1 - 2009
N2 - Background: A new automated immunoassay low-mid volume (≤ 250 immunoassays/day) chemiluminescent analyzer, Abbott Architect i1000 SR, was evaluated by seven laboratories around the world (4 in Europe, one each in Canada, Japan, and the U.S.A.) to demonstrate equivalent performance for key operating characteristics (e.g., precision, turn around time, limit of detection, functional sensitivity, and linearity). Methods: The laboratories followed standard protocols to assess precision, limit of detection (LoD), functional sensitivity, assay linearity, method comparison, and sample carryover. Turn around time for three stat assays (B-hCG, BNP, and CK-MB) and the time required to complete workloads of 50 and 100 tests with a mixture of 75% routine tests and 25% stat tests was also evaluated. Results: Total precision was typically <5% CV for nine immunoassays. Analytical performance met design goals and demonstrated equivalency to package insert data for assays on market and in use for an existing high volume immunoassay system. Stat turn around times were consistent with the fixed analytical time of 15.6 minutes and met the expectations of the laboratories. Measured test throughput ranged from 47 - 54 tests per hour and demonstrated that the analyzer was fit for the intended purpose of supporting a laboratory that performs ≤ 250 immunoassays per day. Conclusions: A multisite, international analyzer familiarization study is a practical means of confirming that a new instrument meets both a manufacturer's design specifications and users' real world expectations and provides a pragmatic test for the system. The experience of investigators at seven sites around the world indicates that a new fully automated chemiluminescent system is suitable for use.
AB - Background: A new automated immunoassay low-mid volume (≤ 250 immunoassays/day) chemiluminescent analyzer, Abbott Architect i1000 SR, was evaluated by seven laboratories around the world (4 in Europe, one each in Canada, Japan, and the U.S.A.) to demonstrate equivalent performance for key operating characteristics (e.g., precision, turn around time, limit of detection, functional sensitivity, and linearity). Methods: The laboratories followed standard protocols to assess precision, limit of detection (LoD), functional sensitivity, assay linearity, method comparison, and sample carryover. Turn around time for three stat assays (B-hCG, BNP, and CK-MB) and the time required to complete workloads of 50 and 100 tests with a mixture of 75% routine tests and 25% stat tests was also evaluated. Results: Total precision was typically <5% CV for nine immunoassays. Analytical performance met design goals and demonstrated equivalency to package insert data for assays on market and in use for an existing high volume immunoassay system. Stat turn around times were consistent with the fixed analytical time of 15.6 minutes and met the expectations of the laboratories. Measured test throughput ranged from 47 - 54 tests per hour and demonstrated that the analyzer was fit for the intended purpose of supporting a laboratory that performs ≤ 250 immunoassays per day. Conclusions: A multisite, international analyzer familiarization study is a practical means of confirming that a new instrument meets both a manufacturer's design specifications and users' real world expectations and provides a pragmatic test for the system. The experience of investigators at seven sites around the world indicates that a new fully automated chemiluminescent system is suitable for use.
KW - Chemiluminescent immunoassay
KW - Immunoassay
KW - Immunoassay analyzer
KW - Instrument evaluation
UR - http://www.scopus.com/inward/record.url?scp=75749132812&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=75749132812&partnerID=8YFLogxK
M3 - Article
C2 - 20099573
AN - SCOPUS:75749132812
VL - 55
SP - 363
EP - 370
JO - Clinical Laboratory
JF - Clinical Laboratory
SN - 1433-6510
IS - 9-10
ER -