The Observatory

May 24, 2016

Infectious Diseases

Hepatitis C kills more Americans than any other infectious disease. Deaths associated with hepatitis C reached an all-time high of 19,659 in 2014, according to new surveillance data released by the Centers for Disease Control and Prevention (CDC). A second CDC study, published online in Clinical Infectious Diseases, shows that annual hepatitis C-related mortality in 2013 surpassed the total combined number of deaths from 60 other infectious diseases reported to CDC, including HIV, pneumococcal disease, and tuberculosis. Further, both studies use data from death certificates, which often underreport hepatitis C, so there likely were even more hepatitis C-related deaths than these numbers suggest.

The greatest hepatitis C burden falls on Baby Boomers—individuals born from 1945 to 1965—many of whom have unknowingly been living with the infection for many years. According to a study published in The Lancet Infectious Diseases earlier this year, many Boomers were infected during medical procedures in the years after World War II, when injection and blood transfusion technologies were not as safe as they are today. Without diagnosis and treatment, they increasingly develop liver cancer and other life-threatening hepatitis C-related diseases, and they may unknowingly transmit the disease to others.

The surveillance data also point to a new wave of hepatitis C infections among people who inject drugs. Acute cases of hepatitis C infection have more than doubled since 2010, increasing to 2,194 reported cases in 2014. The new cases were predominantly among young, white individuals with a history of injection drug use, living in rural and suburban areas of the Midwest and Eastern United States.

Drugs of Abuse

Researchers identify rise in healthcare costs associated with opioid abuse. Infection is a serious complication of intravenous drug abuse and a major cause of illness and death among intravenous drug users. As the national problem of opioid abuse continues to grow, new research offers new insights into the significant impact of opioid-related hospitalizations, infectious complications, and healthcare costs.

Using discharge data from a nationally representative sample of U.S. inpatient hospitalizations, researchers from Beth Israel Deaconess Medical Center and the VA Boston Healthcare System found that hospitalizations related to opioid abuse/dependence increased significantly between 2002 and 2012. While the total number of hospitalizations nationwide remained largely consistent over that period, opioid-related hospitalizations rose 72 percent to 520,275, and opioid-related hospitalizations with serious infection rose 91 percent to 6,535.

The authors’ findings are consistent with previous research that has evaluated the incidence of emergency department visits for nonmedical use of opioids and the rise in accidental deaths as a result of opioid overdose. The costs associated with the rising number of opioid-related hospitalizations have had a significant impact on the U.S. healthcare system. In 2012, the estimated total charge per hospitalization related to opioid abuse/dependence was more than $28,000 and more than $107,000 for hospitalizations due to opioid abuse/dependence with associated infection.

Zika Virus

CDC issues interim guidance for Zika virus testing of urine in the U.S. On the basis of the newly available data, the Centers for Disease Control and Prevention (CDC) recommends that Zika virus rRT-PCR be performed on urine collected <14 days after onset of symptoms in patients with suspected Zika virus disease. Zika virus rRT-PCR testing of urine should be performed in conjunction with serum testing if using specimens collected <7 days after symptom onset.

A positive result in either specimen type provides evidence of Zika virus infection. Procedures for the collection and submission of body fluids, including urine specimens, have been described previously. CDC recommendations for Zika virus testing of serum and other clinical specimens remain unchanged at this time. CDC will continue to review and update guidance for Zika virus testing as new data become available.

Diagnostic testing for Zika virus infection can be accomplished using molecular and serologic methods. Real-time reverse transcription–polymerase chain reaction (rRT-PCR) is the preferred test for Zika virus infection because it can be performed rapidly and is highly specific.

However, in most patients, Zika virus RNA is unlikely to be detected in serum after the first week of illness. Recent reports using adaptations of previously published methods suggest that Zika virus RNA can be detected in urine for at least two weeks after onset of symptoms.

Currently, the CDC Trioplex rRT-PCR assay is the only diagnostic tool authorized by the Food and Drug Administration for Zika virus testing of urine. Other laboratory-developed tests will need in-house validations to adequately characterize the performance of the assay and meet Clinical Laboratory Improvement Amendments requirements. Further investigation is needed to determine the sensitivity and utility of Zika virus rRT-PCR on urine specimens collected ≥14 days after onset of symptoms.

Quest Diagnostics receives FDA EUA for ZIKV test. Quest Diagnostics has received a U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test). The test was developed by the reference laboratory business of Quest’s Focus Diagnostics, Inc., subsidiary. The proprietary molecular test is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from certain individuals.

The test is the first from a commercial laboratory provider to be granted an EUA for testing patients for Zika virus RNA. Until now, the only Zika tests authorized by the FDA under EUA were available from the CDC and were only used in qualified laboratories designated by the CDC. Quest Diagnostics plans to make the new test broadly available to physicians for patient testing.

The EUA authorizes qualified laboratories designated by Focus Diagnostics, Inc., and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests, to perform the Zika RT-PCR test. This test can potentially be performed at any CLIA high-complexity laboratory in the Quest Diagnostics network, which includes several dozen CLIA high-complexity labs in the U.S., including in Toa Baja, Puerto Rico.

For now, only the company’s Focus Diagnostics reference laboratory in San Juan Capistrano, CA, which developed and validated the new test, performs this test.


WHO calls for global action to halt diabetes. The number of people living with diabetes has almost quadrupled since 1980 to 422 million adults, with most living in developing countries. Factors driving this dramatic rise include overweight and obesity. The World Health Organization (WHO) has renewed its call for action against diabetes worldwide. It has identified measures needed, including expanding health-promoting environments to reduce diabetes risk factors like physical inactivity and unhealthy diets, and strengthening national capacities to help people with diabetes receive treatment and care.

Tactics include meeting the organization’s goal to reduce premature death from noncommunicable diseases, including diabetes, by 30 percent by 2030. Governments of member nations have also committed to achieving four time-bound national commitments set out in the 2014 UN General Assembly “Outcome Document on Noncommunicable Diseases,” and attaining the nine global targets laid out in the WHO “Global Action Plan for the Prevention and Control of NCDs”, which include halting the rise in diabetes and obesity. Global efforts are also underway to make medicines more available and affordable.