2004 SERIES ARTICLES

Total Laboratory Automation: Taking It from Dream to Reality
By David J. Morris, MA, DPhil, and Steven Smeal, MS, MT (ASCP)
December 2004

Total laboratory automation utilizing up-to-date technology offers the promise of increased lab accuracy and a long-term savings in cost. Planning and implementing such a complex system, however, is complicated and requires a huge amount of planning. Knowing what pitfalls to avoid will aid in the transition should you decide to make total automation a reality.

Human Immunodeficiency Virus: Antiretroviral Resistance Testing
By Christina Trevino, CLS, and Bruce K. Patterson, MD
November 2004

Due to HIV’s ability to mutate and become resistant to antiretroviral drugs, the need to perform genotype and phenotype analysis has become increasingly important as the HIV pandemic continues to grow. Several types of genotyping assays exist that can detect mutations in the HIV genome, and laboratorians will have to become familiar with this technology as it becomes more important in the treatment of HIV.

C-Reactive Protein: Progress Toward Standardizing Measurement for Cardiovascular Disease Risk
By Gary L. Myers, PhD, and Mary M. Kimberly, PhD
October 2004

C-reactive protein, well known to be an sensitive marker for chronic inflammation in atherosclerosis, has also been shown to be elevated in persons with cardiovascular disease, and could be a strong indicator of coronary events. Although this is promising news, the medical community and government agencies need to reach a consensus on how to best use this marker in clinical practice.

Her2/neu Testing: Current Issues and Future Directions in Breast Cancer Diagnosis
By George M. Kunz, Jr., MD, and Lori J. Sokoll, PhD
September 2004

Amplification of neu gene has been known to result in the overexpression of the Her2 protein, which is found more often in high grade breast cancers. Patients who test positive face an overall decreased likelihood of survival. Patients who test positive for Her2/neu overexpression tend to respond poorly to hormonal therapies, so it is vital to detect the presence of Her2/neu in order to tailor more effective breast cancer therapies.

Prenatal Screening for Down Syndrome: Current Testing and Future Choices
By Jacob A. Canick, PhD
August 2004

Early screening for Down syndrome currently involves the measurement of several biomarkers from a maternal serum sample which are then used, along with the mother’s age, to calculate the risk of an affected pregnancy using a statistical algorithm. Screening methods that can be performed later in the pregnancy are more accurate but carry a risk of miscarriage, although there are potential tests available that could provide a safe and affordable method to accurately screen early for Down syndrome.

Hereditary Colorectal Cancer: Diagnostic Strategies for the Clinical Laboratory
By Linnea M. Baudhuin, PhD, and Stephen N. Thibodeau, PhD
July 2004

The link between colorectal cancer and heredity has been known for well over a hundred years, but not until recently have the genes involved been identified. Genetic testing is now available to identify potential carriers for three of the most common hereditary forms of colorectal cancer: hereditary non-polyposis cancer, familial adenomatous polyposis, and MYH-associated polyposis.

Lab Estimation of GFR: Creatinine Clearance, Creatinine, or Cystatin C?
By Timothy S. Larson, MD
June 2004

Glomerular filtration rate (GFR) is one of the most important factors when assessing the health of the kidneys, used both to diagnose and monitor the progress of a disease. Several different substances can be used to calculate the GFR, but clinicians need to be aware of the limitations of each marker in order to best assess the patient’s health.

Diagnostic Allergy Testing: Some New Answers to Old Questions
By Henry Homburger, MD
May 2004

Assays used to diagnose allergic reactions have been around since the late 1960s, but since that time clinical developments in the understanding and treatment of allergic diseases have increased the lab’s role in how these diseases are evaluated and managed.

Six Sigma: Its Role in the Clinical Laboratory
By Carl Garber, PhD, FACB
April 2004

Six Sigma is a quality metric that combines strategies in decision-making, process improvement, and problem resolution. By implementing the principals of Six Sigma into their lab processes, clinicians will be able to achieve a high degree of reliability and quality while reducing waste and errors.

Imprecision and Physiological Variation: Impact on Uncertainty of Clinical Laboratory Results
By David G. Grenache, PhD
March 2004

Analytical variation occurs in every measurement process, and this must be taken into account when interpreting any result or finding coming out of the lab. Laboratorians must be aware of the possible sources of physiological variation, as well as a test’s limitations and imprecisions, in order to get the most dependable results possible.

Instrument Validation: The Road to Success
By James H. Nichols, PhD, DABCC, FACB
February 2004

Replacing analyzers is a necessary part of any laboratory, and even though developments in technology results in better and more efficient diagnostics, installing and validating new instruments can be challenging for any lab. Proper planning can ensure the likelihood of a smooth transition.

Evaluation of Linearity: Using the Newly Approved NCCLS EP6-A Protocol
By Daniel W. Tholen, MS
January 2004

The linearity of a quantitative measurement is a basic principal of chemistry, and is vital to determining if a calibration is correct. Although there are many different procedures for assessing linearity, not until recently has there been an agreed guideline for labs to follow.