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Chemistry and Immunochemistry Instrumentation/New Reference Ranges

July 2007

Beginning September 11, 2007 the Clinical Laboratories of John Muir Health will complete the conversion of all of its chemistry and immunochemistry assays (> 70 tests) to a single new platform. This change to Beckman Coulter instrumentation is made because of the end of the expected life (5+ years) of our current excellent analyzers from Dade Behring and Diagnostic Products Corp (DPC), and represents one more step of our transition to total laboratory automation and a new state-of-the-art core laboratory. The Core Lab is currently under construction and is slated for completion and occupancy in the first quarter of 2008.

With the new instrumentation comes different reagent and detection systems, thus the need to reevaluate reference ranges for each of the assays. While the majority of tests show no significant difference, the enzymes and certain colorimetric tests do differ. Listed below are the results of extensive correlation and reference range studies of the new vs. old platforms for those assays that change significantly.

New = Slope x Old + Intercept

Analyte Slope Intercept Adult
Old Ref Range
Adult
New Ref Range
Alk phos. 0.8 +4.4 50-136 35-115
ALT 0.9 -14.5 30-65 M: 10-63
F: 10-54
Amylase 1.3 +9.5 25-115 30-140
Creatine Kinase 1.1 +2.5 M: 35-232
F: 21-215
M: 49-397
F: 38-234
CK-MB 1.0 +1.5 0-5 0-6.3
CK-MB %Relative Index 0-4.0 0-3.0
GGTP 0.7 +4.9 M: 15-85
F: 5-55
M: 5-65
F: 5-55
LDH     100-190 100-210
Lipase 0.2 -11.5 114-286 15-51
Iron     35-150 M: 45-182
F: 28-170
TIBC     M: 260-400
F: 260-445
250-450
Uric Acid     M: 3.5-7.2
F: 2.6-6.0
M: 4.8-8.7
F: 2.6-8.0

For each analyte, sex-specific reference ranges have been validated for adults. Considerable collaboration with Children's Hospital Oakland and UC Davis Medical Center, supplemented with literature reviews, has led to assigning age-specific reference range values for pediatrics and adolescents as well. Thus for each assay, lab reports will display the appropriate age and sex-specific reference range for each patient.

As always, if there any questions or concerns, please do not hesitate to contact Barry Latner, M.D. (925) 692-5405, or Connie Houser or Pat Sinz in the Clinical Laboratory at MuirLab (925) 692-5631. Thank you.

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Change is Certain

Barry P. Latner, M.D.
Medical Director

In anticipation of opening a new state-of-the-art Core Lab, the process of updating instrumentation is underway. Last month ushered in the beginning of an approximately six-month endeavor to replace our workhorse chemistry and immunoassay instruments. At MuirLab on the Walnut Creek campus, 23 immunoassays went live. These included tests of thyroid function (e.g. 3rd generation TSH and Free T4), several therapeutic drugs, and several tumor markers. By early summer, all of the remaining 100 or so chemistry tests will be brought up on our new platform at MuirLab. Concurrently, all chemistry and immunochemistry testing on the Concord campus will make a change to the new instrumentation as well. By choosing a single manufacturer for all of these assays throughout the John Muir Health System, we are aiming for reproducible and reliable results with the same reference ranges no matter where the specimen is run. We are striving to make this transition as seamless as possible.

While the majority of the new assays will give nearly identical results as they do now because they are more standardized (e.g. electrolytes, proteins, therapeutic drugs, and lipids), there are several others that will show significant changes. This latter group includes such tests as tumor markers and enzymes. Because variations in assay format (i.e. reagents, antibodies, detection systems, etc.) are responsible for differences observed in the concentration of the tumor markers and enzymes when measured by different instruments, their values cannot be used interchangeably. As more of these tests get closer to being implemented, communiqués outlining their performance will be forthcoming.

As always, should there be any questions or concerns, please do not hesitate to call. Thank you.

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Hematology Analyzer Beckman Coulter LH 750

The John Muir Medical Center, Walnut Creek Campus Laboratory is pleased to announce our upgrade to Beckman Coulter's latest, state-of-the-art Hematology Analyzer, the LH 750.

This instrument provides several advantages over its predecessor, the GenS. The new instrument gives the Clinical Laboratory Scientists a streamlined procedure which includes: no daily maintenance, no sample pre-sorting, reduced set-up time, optimized throughput, and less reagent wastage.

The system also provides an expanded clinical range, significant reduction in flagging, improved abnormality sensitivity and specificity. This means that far fewer smear reviews will need to be performed improving turn-around-times. The new technology increases linearity of WBCs to 400,000/mm3 and platelets to 3,000,000/ mm3. The instrument provides enumerated nucleated red blood cells. White blood cell counts are automatically corrected for interfering substances such as nucleated red blood cells, giant platelets, and unlysed red cells.

With this advance in technology there should be a reduced need to order a CBC with Manual Differential. The advanced flagging will ensure that an order for a CBC with Automated Differential will reflex to a manual differential when one is indicated.

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The Immunology Department at John Muir Walnut Creek Announces the ADVIA Centaur System

The Immunology Department at John Muir Walnut Creek has acquired new instrumentation that will provide enhanced service for infectious disease, autoimmune, and oncology testing.

The ADVIA Centaur System is designed to handle increasing testing volumes while decreasing time and labor. Throughput is up to 240 tests per hour with on-board dilution, repeat and reflex testing features. The precision of direct chemiluminescence technology and the flexibility of a fully automated random access testing system combine to deliver high-quality results quickly and efficiently. No-pause loading of reagents and consumables allows true STAT testing capability. Superior sensitivity and specificity is now available for infectious disease testing, including viral hepatitis and congenital assays. Smart algorithm software allows automatic repeats and confirmatory testing for reactive samples.

Test Code Assay Specimen Performed Reported
10272 Anti-HBs serum - SST Daily Same Day
10262 HBsAg serum - SST Daily Same Day
10282 HBc Total serum - SST Daily Same Day
10292 HBc IgM serum - SST Daily Same Day
10302 HAV serum - SST Daily Same Day
10312 HAV IgM serum - SST Daily Same Day
10322 HCV serum - SST Daily Same Day
13281 Rubella IgG serum - SST Daily Same Day
13181 Toxoplasma IgG serum - SST Daily Same Day
13182 Toxoplasma IgM serum - SST Daily Same Day
13026 Anti-TPO serum - SST Daily Same Day
13027 Anti-Thyroglobulin serum - SST Daily Same Day
13330 Homocysteine EDTA plasma* Daily Same Day
10636 Intact PTH EDTA plasma* Daily Same Day
12307 CA 19.9 serum - SST Daily Same Day
11385 CA 27.29 serum - SST Daily Same Day

*Homocysteine and Intact PTH specimens must be transported refrigerated and centrifuged as soon as possible after collection for separation from the cells to insure optimal stability.

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Microbiology

Microbiology has upgraded the Microscan Walkaway instruments (which perform sensitivity testing) with the LabPro operating system. The new software streamlines workflow, and provides enhanced manipulation of data and epidemiology statistics.

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