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NEWS AT PRL

Additional Reticulocyte Parameter

Beginning March 3, 2008, Physicians Reference Laboratory will begin reporting an additional parameter with automated reticulocyte counts. The CHr (reticulocyte Hemoglobin Content) will now be included on all reticulocyte counts performed on the Siemens Advia 2120 hematology analyzer.

CHr has been found to be an early indicator of iron deficiency, particularly in dialysis patients.  CHr may also be a strong predictor of iron deficiency in pediatric populations. Because reticulocytes are the earliest erythrocytes released to the circulation blood, CHr provides and early measurement of iron deficiency when changes in the red blood cell parameters or other biochemical tests are not apparent. In addition, CHr is an early indicator of response to iron treatment.

“Reticulocyte hemoglobin content (CHr) is derived from the simultaneous measurement of volume and hemoglobin concentration of both mature red blood cells and reticulocytes. Laser-based technology utilized in the Siemens Advia 2120 allows the measurement of hemoglobin content of each cell.” (Siemens Diagnostics) The CHr is generated with each automated reticulocyte count performed on the Advia 2120

Adult reference range for CHr  28.9 – 35.4 pg.
 (Pediatric ranges have not been established by PRL.)

The new CPT Code for Reticulocyte is 85046  (Blood count; reticulocytes, automated, including reticulocyte hemoglobin content (CHr)

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Physicians Reference Laboratory Announces New Diagnostic for Women’s Health

OVERLAND PARK, Kan., Feb. 5 /PRNewswire/ -- Physicians Reference Laboratory ("PRL") announced today that it has developed the most comprehensive, commercially available HPV test to date.  Under the marketed name COMPLeTe Care HPV, the test allows for early detection and differentiation between all 15 high risk types of HPV which can lead to cervical cancer.
Worldwide, cervical cancer is the second most common form of female cancer with an incidence of over 500,000 new cases and 300,000 deaths each year. If detected early, cervical cancer precursors can be treated effectively. Research worldwide has shown that virtually all cervical cancer is caused by human papillomavirus (HPV). Women persistently infected with certain carcinogenic types are at increased risk of developing severe dysplasia which can lead to cervical cancer.
According to PRL CEO, Spencer Kerley, M.D., “Of the over 100 HPV types, 15 are considered as high-risk for development of cervical cancer.”  Under the direction of Pradip Manna, Ph.D., Director of Molecular Diagnostics, PRL developed a test capable of specifically detecting all genomic variants of each high-risk HPV type.  The specificity and accuracy of the test will help physicians better manage their patients’ risk of developing cervical cancer.

“Women of all ages will benefit from PRL’s COMPLeTe Care HPV.  In addition to early detection, type differentiation can lead to higher success rates for HPV vaccines”, said Dr. Kerley.

About Physicians Reference Laboratory
Physicians Reference Laboratory, LLC. is a privately owned, full-service diagnostic testing laboratory. For 30 years PRL has been renowned for incorporating new and innovative testing procedures and employing the most highly qualified professionals. By utilizing market leading technologies and providing expert service, PRL's focus is on efficiently delivering accurate diagnostic data to support the advancement of our customers' efforts, ultimately leading to the highest quality of patient care.

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Please visit PRL Central Laboratory Services at the following events in 2008

Event Date Location
6th Annual Partnering with Central Labs, ECG, and Imaging Labs Jan 23-25, 2008 Lake Buena Vista, FL
United States and Canadian Academy of Pathology Mar. 1-7, 2008 Denver, CO
American Society of Colonoscopy and Cervical Pathology Mar. 17-21, 2008 Disney World, Orlando, FL
17th Annual Partnerships with CRO's and Other Outsourcing Providers Apr 14-16, 2008 Las Vegas, NV
American College of Obstetricians and Gynecologists Annual Clinical Meeting May 3-7, 2008 New Orleans, LA
44th DIA Annual Meeting Jun 22-25, 2008 Boston, MA
2008 AAPS Annual Meeting and Exposition Nov 16-20, 2008 Atlanta, GA

 

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Test Update:  Percent Hemoglobin A1C in blood.

Effective date:  August 20, 2007 *

The method for determination of Hemoglobin A1C percent in use by Physicians
Reference Laboratory will change as of August 20, 2007.

 
Current Method: Bayer Advia 1650 Immunoturbidimetric
This method is sensitive to hemoglobin variants.

 
New Method: Biorad D-10 (HPLC). The D10 utilizes principle of ion-exchange high-performance liquid chromatography. Separation is optimized to minimize interferences from hemoglobin variants. This method is NGSP certified to correlate with guidelines as described in the DCCT.
 
Reference interval: 4.0 – 6.0 %. There is no change in reference interval at this

time. *
 
The following note will accompany patient values if HbS or HbC are determined:
 
"The sample appears to contain abnormal hemoglobin, possibly Hemoglobin-S" or
"The sample appears to contain abnormal hemoglobin, possibly Hemoglobin-C".

 
Sample Requirements: EDTA whole blood, minimum 2.0 mL

Separate EDTA tubes are required for Hemoglobin A1C and CBC testing.

Due to specimen handling requirements during performance of Hemoglobin A1C by the new Biorad D10 method, add-on testing for a CBC to samples previously tested for Hemoglobin A1C will not be permitted. *

For questions, please call Teresa Smith, MT, Chemistry Supervisor, or Dr. Cummings, Chief, Clinical Pathology, at PRL (913-338-4070).
 
Thank you.
 
Kenneth C. Cummings, MD
Chief, Clinical Pathology
Physicians Reference Laboratory

* changes

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Complete Care HPV Comprehensive Oncogenic Molecular Papillomavirus Laboratory Testing

PRL is pleased to announce COMPLeTe Care HPV*

June 14, 2007 - PRL is pleased to announce COMPLeTe Care HPV*, Comprehensive Oncogenic Molecular Papillomavirus Laboratory Testing, a new state-of-the-art molecular test for simultaneous detection and typing of all 15 high risk human papilloma viruses (HPV), effective from June 14, 2007.

Key Benefits of COMPLeTe Care HPV Test:

  • Simultaneous detection and typing of all 15 high risk HPV types
  • The type-specific results will provide more specific information when determining risk assessment
  • Carefully designed & continually updated test to assure detection of all known genomic variants of each high risk HPV type
  • Built in internal control for higher accuracy
  • Wide variety of clinical specimens (ThinPrep® Pap, cervical swabs, and tissues)
  • Highly sensitive and specific
  • Detection of other sexually transmitted infections from the same specimen
    (Herpes (HSV), Chlamydia, Gonorrhea)
  • Faster turnaround time, 1-3 days
Current Limitations of HPV Detection…
  • Limited specificity & sensitivity
  • No type-specific identification
  • No distinction between single vs. multiple high risk HPV infections
  • Frequent “indeterminate” or “equivocal” result
  • Detection of only 13 of the 15 high risk HPV types
  • No internal control
  • Cross reactivity with a number of non-specific HPV types as well as pBR322, a homologous bacterial plasmid sequences has been reported in human genital specimens
  • Time consuming
  • Processed specimen may not be used for the detection of other sexually transmitted pathogens, such as Herpes (HSV), Chlamydia, Gonorrhea

*patent pending

For additional information about this test, please do not hesitate to contact Dr. Manna or Dr. Kerley at 913-338-4070.

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PRL is now performing a new molecular test for Herpes Simplex Virus

April 9, 2007 - PRL is now performing a new molecular test for Herpes Simplex Virus (HSV RQ-PCR, #5855, CPT 87529), effective from April 9, 2007. With the implementation of this new technology and the advantages it offers, PRL will discontinue the viral culture methodology for Herpes as of August 1, 2007. We believe that you and your patients will be better served by ordering the HSV RQ-PCR than by ordering either a Herpes Culture or Herpes Antibody Panel.  If you have any questions or concerns after reviewing the information please don’t hesitate to call Dr. Pradip Manna at 913-338-4070.

Key Benefits of HSV RQ-PCR:

  • New Gold Standard
  • Test patients with signs of infection, irrespective of anatomic site
  • PCR is 2-14 times more sensitive than culture
  • Simultaneous detection and type-specific identification of HSV types 1 & 2
  • Built in internal control to determine specimen quality, nucleic acid extraction efficiency, and PCR reaction inhibition
  • Highly sensitive, specific, and wide range of detection
  • Virtually any clinical specimen type, genital swab, lesion, CSF, Pap, blood, tissue, amniotic fluid

  • Less stringent specimen collection, storage, and shipping conditions as molecular testing does not require live virus

  • Faster turnaround time, 1-3 days initially (within 24 hours, later on)
  • False-positive and-negatives are rare

Challenges of HSV Detection by Culture

  • Low sensitivity

  • False-negatives are common (up to 76%)
  • Requires special sampling and transportation to get live virus
  • Time consuming

Challenges of HSV Detection by Serology

  • Depending on antibody used, serology may provide very little clinical utility
  • Determines past exposure
  • Depending on immune status, seropositivity may not occur in rare cases
  • Recommended for testing patient without signs of infection e.g. lesion
    • assessing risk of a patient with a previous or a current partner with HSV
    • screening of pregnant woman to determine risk status
  • Caution: Absence of orofacial or genital lesions may not rule out the possibility of active HSV infection

If you have any questions relative to this change, please contact Dr. Pradip Manna (dr.manna@prlnet.com or 913-338-4070).

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