The Effect of Simulated Field Storage Conditions on the Accuracy of Rapid User-Friendly Blood Pathogen Detection Kits

MILITARY MEDICINE, 177, 5:583, 2012 The Effect of Simulated Field Storage Conditions on the Accuracy of Rapid User-Friendly Blood Pathogen Detection Kits Diane R. Bienek, PhD; David G. Charlton, DDS ABSTRACT Being able to test for the presence of blood pathogens at forward locations could reduce morbidity and mortality in the field. Rapid, user-friendly blood typing kits for detecting Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), and Hepatitis B Virus (HBV) were evaluated to determine their accuracy after storage at various temperatures/humidities. Rates of positive tests of control groups, experimental groups, and industry standards were compared (Fisher’s exact c 2, p £ 0.05). Compared to the control group, 2 of 10 HIV detection devices were adversely affected by exposure to high temperature/high humidity or high temperature/low humidity. With one exception, none of the environmentally exposed HCV or HBV detection devices exhibited significant differences compared to those stored under control conditions. For HIV, HCV, and HBV devices, there were differences compared to the industry standard. Collectively, this evaluation of pathogen detection kits revealed that diagnostic performance varies among products and storage conditions, and that the tested products cannot be considered to be approved for use to screen blood, plasma, cell, or tissue donors. INTRODUCTION During military operations, hemorrhage is a leading cause of death in military trauma patients.1,2 For a successful outcome, hemorrhagic injuries must be treated in a timely fashion by properly trained health care workers who have adequate medical supplies. In some situations, injury may be so severe that blood replacement via transfusion is necessary. However, depending upon specific circumstances, at farforward locations no blood support may be available.3 Regardless of this limitation, emergency transfusions may be necessary. In such cases, warm fresh whole blood transfusion using “walking wounded” and/or in-facility staff personnel as donors is possible. In fact, recent conflicts have demonstrated the value of this technique.4–6 Combat hospitals in Iraq and Afghanistan have, by necessity, used fresh whole blood for transfusion, and one recent report documents the use of more than 6,000 units of warm fresh whole blood for the treatment of life-threatening traumatic injuries with hemorrhage.6 One of the risks associated with the use of fresh whole blood for transfusions is transmission of infectious agents.7 In general, the rates of transfusion-transmitted diseases such as Naval Medical Research Unit San Antonio/General Dynamics Information Technology, 3650 Chambers Pass, Building 3610, Fort Sam Houston, TX 78234-6315. The views expressed in this article are those of the authors and do not necessarily reflect the official policy or positions of the Department of the Navy, Department of Defense, or the U.S. Government. The use of commercially available products does not imply the endorsement of these products or preferences to other similar products on the market. The authors have no financial interest in either the products or the products’ manufacturers/distributors. No direct or indirect support was provided by any commercial interest. We are military service members or employees of the U.S. Government. This work was prepared as part of our official duties. Title 17 U.S.C. §105 provides that ‘Copyright protection under this title is not available for any work of the U.S. Government.’ Title 17 U.S.C. §101 defines a U.S. Government work as a work prepared by a military service member or employee of the U.S. Government as part of that person’s official duties. Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV) have decreased in recent years.8–10 More discriminating donation selection criteria, improved donor education, and increased sensitivity of testing techniques have contributed to this reduction.8,9,11,12 Despite this general downward trend, at least one study suggests that continued monitoring of the blood supply and research is warranted. In a study of 66 million blood donations during the period from 1999 to 2008, HCV prevalence among first-time donors decreased by 53%. However, HIV and HCV incidence among repeat donors increased in 2007 though 2008 compared to 2005 through 2006.13 Despite relatively low current rates, the seriousness of these diseases continues to motivate researchers to attempt to further reduce the risk. One of the critical steps in minimizing the rates of transfusiontransmitted infections is to ensure that donated blood is tested to ensure it is free of pathogens such as HBV, HCV, and HIV. Field friendly, point-of-care products for testing blood for the presence of such pathogenic organisms are commercially available, and at least one study indicates that they can be helpful in reducing the risk of HIV, HCV, and HBV.7 Since the U.S. military operates in a variety of environments, the medical supplies and devices it uses must be resistant to degradation from extreme temperature and humidity conditions. The Naval Medical Research Unit San Antonio (formerly the Naval Institute for Dental and Biomedical Research, Great Lakes, IL) has exposed medical and dental supplies and equipment to different environmental conditions for various time periods and then tested their performance.14–17 The tests indicated that environmental exposures had adverse effects on many of these products. Although previous testing has included field dental equipment and point-of-care blood typing kits, products for point-of-care blood pathogen detection have not been tested. It is important to test the temperature and humidity resistance of these products as they may eventually be used on the battlefield. MILITARY MEDICINE, Vol. 177, May 2012 583 Effect of Simulated Field Storage on User-Friendly Blood Pathogen Detection Kits The objective of this study was to determine the accuracy of point-of-care blood pathogen detection products after storage under temperature and humidity conditions simulating those commonly encountered in the field. MATERIALS AND METHODS Specimens Blood products were purchased from Golden West Biologicals (Temecula, CA) using a donor site that is a U.S. Food and Drug Administration (FDA)-inspected and American Association of Blood Banks-accredited facility. The only donor information that accompanied each sample was sample reactivity (HIV, HCV, or HBV), gender, ethnic group, age, and anticoagulant used for specimen collection. As such, the investigation was deemed to be Institutional Review Boardexempt. Samples were frozen, packed, and shipped to the authors for analyses. Upon receipt, the specimens were stored at –20 C until tested. After thawing, the samples were used within 14 days. HIV, HCV, and HBV status was determined using industrystandard procedures set forth by the FDA. These results served as the gold standard agai (...truncated)