CLN Article

The Sample

A Call for Universal HCV Screening

Based on their findings among nearly 5,000 patients seen at the Johns Hopkins Hospital emergency department (ED), researchers are recommending universal hepatitis C virus (HCV) screening for all adults ages 18 and older (Clin Infect Dis 2016;62:1059–65). If implemented, this recommendation would capture up to 25% of individuals with undiagnosed HCV infection who would not be identified by current screening guidelines, according to the investigators.

The Centers for Disease Control and Prevention (CDC) since 2012 has recommended one-time testing for all individuals born between 1945 and 1965, in addition to the agency’s long-standing risk-based recommendation, targeting individuals with HIV; individuals with a history of injection drug use, hemodialysis, transfusion, or transplants; children born to HCV-infected women; and individuals with persistently abnormal alanine aminotransferase levels. Prior studies have reported high prevalence of HCV antibody positivity—from 13% to about 18%—in urban ED populations. The Johns Hopkins researchers wanted to determine the overall burden of HCV infection and evaluate the sensitivity of CDC recommendations in their urban ED.

The 8-week study involved HCV testing among all ED patients who were at least 18 years old and had excess blood specimens. The samples were de-identified, but clinical and demographic data and HCV lab test results were linked for study analysis. The researchers conducted HCV testing with the Genedia HCV enzyme immunoassay.

Of 4,713 unique patients with excess blood specimens taken as part of routine care, 13.8% were HCV antibody-positive. Nearly one-third of these individuals had undocumented HCV infection. Of those with undocumented HCV infection, nearly half would have been diagnosed based on birth cohort testing, while 26.5% would have been identified based on risk-based testing, including injection drug use and HIV infection. However, just testing in accordance with CDC guidelines would have missed 25% of cases.

Among those who would have been missed by current screening recommendations, the researchers found increased HCV seroprevalence in nonblack men and women born between 1979 and 1995, 7.6% and 5.7%, respectively. This relatively high seroprevalence was not such a surprise in light of a recent community outbreak of HIV and HCV in Indiana linked to injection drug use, according to the researchers.

The 13.8% overall seroprevalence would equate over the course of a year at Hopkins to about 8,000 unique HCV antibody-positive patients and 6,700 with chronic HCV infection.

The researchers acknowledged that their proposal to broadly expand HCV testing would demand significant resources, but emphasized the importance of identifying patients early in the course of HCV infection. “This is an infection that can now be cured if detected early, rendering people noninfectious and thereby preventing the dire consequences that are associated with the virus,” said senior author Thomas Quinn, MD, a professor of medicine at Johns Hopkins.

Analysis Details Costs of Genetic Sequencing

A micro-costing analysis conducted by a working group of the Association for Molecular Pathology found that across five representative laboratories, it cost $577 to $908 to perform targeted genomic sequence analysis of DNA from a solid tumor that fulfilled the criteria for current procedural technology (CPT) code 81445 (J Mol Diagn 2016;18:319–28). Data from two laboratories demonstrated that it cost $1,048 and $1,949 to perform hearing loss genomic sequencing analysis that fulfilled the criteria for CPT code 81430, while data from three laboratories showed exome sequencing analysis costs ranged from $1,499.32 to $3,388.18.

The increasing use of genetic sequencing in clinical practice makes it important for patients, providers, and payers to understand its value, according to the authors. “Genomic sequencing procedures are changing the way clinicians are diagnosing and managing hereditary diseases and the delivery of oncology care,” said lead author Linda Sabatini, PhD, HCLD, director of molecular diagnostics at NorthShore University HealthSystem in Evanston, Illinois. “We hope that laboratories will use these tools to assess their individual costs, to consider the value structure in their own patient populations, and to contribute their data to the ongoing dialogue regarding the impact of [genomic sequencing procedures] on improving patient care.”

The working group selected five CPT codes—81430, 81470, 81445, 81455, and 81415—as representative applications of genomic sequencing procedures across the spectrum of technology and data analysis. The researchers contacted 65 laboratories, of which nine participated, providing 13 unique testing protocols. All the laboratories indicated they had been performing genomic sequencing and clinical interpretation and reporting for at least 6 months and running at least one batch of five or more samples per week.

The authors sought to capture the individual steps involved in genomic sequencing, from DNA extraction to library preparation, sequencing, quality control, and data analysis. They considered reagent, equipment, and staffing costs for the procedures.