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Lab Reference Values

Beginning June 25 all Norton hospitals and Kosair Children’s Medical Center  – Brownsboro laboratories will be converting to Vitros analyzers from Ortho Clinical Diagnostics (OCD).  The new instruments offer several menu enhancements, improved turnaround times and  significant cost savings.

The new instrumentation will result in changes to the methodologies used to perform some tests, which will change some analytes’ reference ranges. The new reference ranges will be reported with each test result when the instruments are put in service.  

Although most of the reference value changes are minor, a few are significant and are listed below.

Analyte

Units

Current Reference Range

New Reference Range

ALT

U/L

7-52 U/L

13-69

Ferritin

ng/dl

15-200  Male
12-150  Female

18-464 Male
6-264 Female

LDH

U/L

140-271

313-618

Lipase

U/L

11-82

23-300

Protein, CSF

mg/dl

15-45

12-60

Troponin

ng/dl

0.00-0.06 Negative
0.07-0.63 Indeterminate
> 0.64  Suggests evidence of Myocardial Damage

0.00-0.034  Negative
0.035-0.119 Indeterminate
>= 0.120 Suggests evidence of Myocardial Damage

Other important changes with the new equipment include:

  • The new troponin methodology is a high sensitivity assay that will be able to detect much more subtle changes in troponin levels at lower ranges.  Consequently, the lower limit of normal has decreased to 0.034 ng/ml.  Anything above this level is considered abnormal, and anything above 0.120 indicates a high probability of myocardial infarction in patients with symptoms of ischemia.  For more information about the use of high sensitivity troponins, refer to: http://www.clinchem.org/content/55/5/930.full.pdf+html
  • The new analyzers also have the advantage of performing a direct measurement of both conjugated and unconjugated bilirubin.  The previous instruments used an older, less accurate methodology.  
  • The new system offers a neonatal bilirubin which should be ordered on neonates 14 days old and younger.  If a neonate needs bilirubin monitoring after 14 days of age, the pediatrician should continue ordering neonatal bilirubin for consistency until the infant no longer needs to be followed.  For specimens from older pediatric patients or adults, physicians should continue to order a “fractionated bilirubin.”  “Fractionated bilirubin” should not be ordered on neonatal samples since biases up to +/- 10 percent have been reported on these samples. 
  • Cancer marker testing will also change on the new analyzers.  Results correlate well with the current methodologies so serial testing should be unaffected.  However, significant changes in any given patient’s marker level should be correlated with clinical findings.  The CA 15-5 assay will be offered for the same MUC1 gene-derived glycoprotein previously tested by the CA 27.29 assay.  Results should be interchangeable.  However, establishing a new baseline measurement with CA 15-3 is suggested.

Remember, all printed and electronic reports will contain the reference ranges specific for the methodology used to generate the test results. 

If you have questions about the new assays or reference ranges please contact your respective hospital’s laboratory medical director.

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