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NBSB Pandemic Influenza Working Group Detailed Report Influenza Diagnostics: Algorithm & Identification Capabilities within DoD—COL Dan Harms, Center for Clinical Laboratory Medicine COL Harms noted that the military health system has the same goals for surveillance and diagnostic testing as CDC does for the general public: detect introduction of a novel influenza into the United States or overseas DoD locations and monitor changes in the pandemic virus, including development of antiviral resistance. Laboratory planning should take into account that influenza, other than H1 and H3 subtypes, have the potential to become pandemic and that shortages of supplies and staff may occur. COL Harms noted that supply shortages did occur with the initial outbreak. The military health system is following current CDC guidance for case definitions and testing guidance. As demonstrated at the initial outbreak, testing everyone can overwhelm State public health labs and DoD labs. COL Harms stated it would be beneficial if the CDC recommendations, on who to test once the presence of novel influenza virus infections in a geographic region, were firmly established and more consistently followed/implemented (would tend to alleviate laboratory overload caused by a desire to test/diagnose every case). The military system emphasizes the use of rapid diagnostic tests. The tests should be capable of differentiating type A and B, and should support the local command’s pandemic influenza response plan. Hospitals must amend or establish Clinical Laboratory Improvement Program (CLIP) laboratory certificates as required (CLIP is DoD’s CLIA-equivalent program). Medical staff should be aware of the test’s sensitivity, specificity, PPV, and NPV. COL Harms explained the flow of testing for suspected cases of H1N1. Generally, for a positive rapid test result—or a negative test result in a high-risk person for whom there is a high index of clinical suspicion that a H1N1 infection is present—a PCR test is performed. Alternatively, within the Army’s Medical Command, a specimen from a patient with a negative rapid test result for whom there is a high index of clinical suspicion that a H1N1 infection is present is first referred for viral culture. Specimens from Flu A positive cultures are subsequently referred for a PCR test. Positive PCR results trigger consultation with the CDC. The military health system was more prepared to diagnose H5N1 (due to DoD laboratory participation in the CDC’s Laboratory Response Network), not H1N1, and only had two sites capable of performing the CDC five-target influenza assay when the H1N1 outbreak occurred (i.e., the U.S. Air Force School of Aerospace Medicine (USAFSAM) in San Antonio, TX, and the Naval Health Research Center (NHRC) in San Diego, CA). Army medical centers, in general, had no influenza subtyping diagnostics at the time of the H1N1 outbreak. Specimens for H1N1 RT-PCR testing are currently sent to the nearest reference laboratory, which may be either a State public health lab or a DoD lab, and specimen referral follows the reference lab’s guidance. DoD has routine influenza surveillance capability through USAFSAM and NHRC; the Air Force Surgeon General oversees DoD’s formal influenza surveillance program. 60
NBSB Pandemic Influenza Working Group Detailed Report USAFSAM collects specimens from sentinel sites at 43 military installations and 9 allied countries. Specimens from each site are analyzed and subtyped weekly, and some are sent to CDC for further analysis. NHRC conducts population-based febrile respiratory illness surveillance at eight training sites and 20 shipboard sites and along the Mexican border. USAFSAM and NHRC were instrumental in identifying the first U.S. cases of H1N1. USAFSAM was able to purchase additional PCR platforms quickly in early May, which doubled its testing capacity. The Army Medical Command (MEDCOM) had a stockpile of rapid antigen test kits that were stored at three sites that were distributed in response to the H1N1 outbreak. MEDCOM also had previously sent centrally procured nucleic acid extraction kits and PCR enzymes directly to medical center labs. DoD is now seeking to replenish its rapid antigen test diagnostics resources and is looking at whether to address shortages with viral transport media and viral culture cells. By the end of June, the Army’s Medical Command is expected to award a contract to increase PCR diagnostics instruments. A PCR instrument was also moved to the Walter Reed Army Institute of Research’s CLIP-registered lab. The Navy also bought more PCR diagnostics instruments, which will be located in deployable units. COL Harms said that, ideally, public health and DoD medical center laboratories would have high throughput PCR testing capability for typing/subtyping influenza viruses, and all DoD hospitals have a pandemic-influenza-specific POC rapid antigen test that is sufficiently sensitive. Once the presence of novel influenza virus infections within a population/community is firmly established, testing emphasis should shift to detection of novel influenza virus infections in new communities/geographic locations. Discussion 2 Dr. Pavia: It sounds like DoD tripled its throughput capacity. The strategy seems to be limited, though, so are you going to revise your strategy with the higher capacity? What would you do with increased capacity? COL Harms: We see that State public health labs will be clogged with requests. Having our own system protects us. But how DoD can assist State public health labs is currently under discussion. Many DoD labs are members of the CDC’s Laboratory Response Network, and that includes assisting other member laboratories during a surge. The H5 assay went out under the Laboratory Response Network (LRN), so all those labs had the H5 capability. The CDC five-target assay posed a problem: Texas asked for assistance from USAFSAM, but it was not an LRN assay, so that impeded providing the requested assistance. When DoD labs applied for admission to the LRN, whether we could provide assistance without a Stafford Act declaration of emergency or Economy Act request was evidently not addressed. We’re looking at the rules and what we can do, particularly whether there are workarounds to provide surge testing assistance to civilian/non-DoD laboratories without reimbursement. 2 This and subsequent discussions paraphrase the questions and comments of the participants. This document does not represent a verbatim transcript. 61
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