SOFT/TIAFT 98 - Abuscreen OnLine Immunoassay for the Detection of Drugs of Abuse on the ...

SOFT - TIAFT 1998

Poster Session 2

Wednesday October 7, 1998

ABUSCREEN ONLINE^® IMMUNOASSAY FOR THE DETECTION OF DRUGS OF ABUSE ON THE INTEGRATED HITACHI 917 ANALYZER

Kenneth V. Savoca, Jodi Blake-Courtney, Jane S. Fields, Sharmila Honasoge, Zhuyin Li, Sergiusz Polakowski, Haiying Wang, Alan J. McNally, and Salvatore J. Salamone

Roche Diagnostics Systems, Inc., 1080 US Highway 202, Somerville, NJ 08876, USA

Applications for the Abuscreen OnLine DAT tests were developed on a new integrated Hitachi 917 analyzer. These assays include Amphetamines 1000 cutoff, Barbiturates 200 cutoff, Benzodiaze-pines 100 cutoff, Benzodiazepines 200 cutoff, Benzodiazepines 300 cutoff, Cocaine 300 cutoff, Methadone 300 cutoff, Opiates 300 cutoff, Opiates 2000 cutoff, PCP 25 cutoff, Propoxyphene 300 cutoff, THC 20 cutoff, THC 50 cutoff, and THC 100 cutoff. This random access analyzer has the capacity to consolidate the testing of clinical chemistry, therapeutic drugs, drugs of abuse, specific proteins, thyroids, and electrolytes on one system. The throughput of the instrument is 800 tests per hour and the maximum throughput is 1200 tests per hour with ISE.

The OnLine DAT assay format, based on the KIMS technology, has been successfully applied to the 917 in either a dedicated DAT analyzer format or in an integrated format. A calibration curve for each assay was obtained using a Logit Log 4 parameter or a Logit Log 5 parameter with either four or five calibrators. The precision at 0.75x, 1.0x, and 1.25x the cutoff was measured. The average intra-assay CV was 1.7% and the average inter-assay CV was 2.8% at these concentrations for all assays.

Intraassay Precision Interassay Precision

Assay Cutoff 0.75X X 1.25X 0.75X X 1.25X

Amphetamines 1000 2.0 1.4 1.5 2.0 1.4 1.5

Barbiturates 200 3.0 2.8 1.5 3.3 2.8 2.6

Benzodiazepines 100 1.9 1.0 1.3 2.1 1.7 1.6

Benzidiazepines 200 2.7 1.9 1.5 3.3 2.1 2.2

Benzodiazepines 300 1.2 1.4 1.1 1.8 2.0 1.7

Cocaine 300 1.1 0.9 0.6 1.4 1.0 0.7

Methadone 300 3.2 1.5 1.0 3.7 2.2 2.0

Opiates 300 1.2 1.0 0.8 1.6 1.2 1.9

PCP 25 4.3 2.0 2.1 6.6 5.0 4.0

Propoxyphene 300 1.3 1.6 1.0 3.1 2.4 2.4

THC 20 3.2 2.9 1.5 8.5 4.6 3.3

THC 50 1.1 1.5 2.2 4.0 3.3 5.8

THC 100 1.7 2.0 1.9 2.6 3.8 3.2

In a clinical correlation study, OnLine results were in 100% agreement with 50 GC-MS confirmed clinical positive samples per assay. The cross-reactivities for all the assays were similar to those reported for OnLine applications on other analyzers. These reagents will be offered in prepacked 20 mL or 70 mL Hitachi reagent pies, ready for use on the 917 analyzer.

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