Program Schedule

Evaluation of Diatherix Laboratories TEM-PCR: a novel multiplex diagnostic panel for detection of bacterial and viral respiratory pathogens

Session: Poster Abstract Session: Diagnostic Microbiology: Bacterial Infections
Saturday, October 11, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Background: A broad array of pathogens causes influenza-like illness (ILI). Knowing etiology aids treatment and prevention. Novel multiplex diagnostic panels have been developed. Evaluating their performance on clinical isolates is warranted.

Methods: An observational study of febrile ILI among otherwise healthy subjects (0-65y, majority outpatient) is ongoing at five US military hospitals. Nasopharyngeal specimens are tested by single reaction PCR for influenza, human rhinovirus (HRV), and adenovirus. A  subset of 403 specimens (78 influenza PCR-positive, 54 HRV PCR-positive, 10 adenovirus PCR-positive, 263 influenza- , HRV- and adenovirus PCR-negative) was tested by a target‐enriched multiplex PCR (TEM-PCR) panel for 13 bacterial and 10 viral respiratory pathogens (Diatherix Laboratories, Inc.; Huntsville, AL). 

Results: Of 403 specimens, 387 were evaluated by TEM-PCR with 259 (67%) positive for at least one virus. Compared to single reaction PCR, the sensitivity/specificity of TEM-PCR was as follows: influenza A (94%, 99%); influenza B (65%, 99%); HRV (68%, 90%); adenovirus (40%, 100%). Viral detection rates were: HRV, n=61 (16%); Influenza A, n=51 (13%); Coxsackie/Echovirus, n=45 (12%); Coronavirus, n=42 (11%); RSV, n=40 (10%); Parainfluenza, n=32 (8%); Human Metapneumovirus, n=18 (5%); Influenza B, n=17 (4%); Adenovirus, n=4 (1%); Bocavirus, n=1 (0.3%). Decreased TEM-PCR panel sensitivity can be explained by suboptimal sample volume used for nucleic acid extraction.

A total of 304 (75.4%) specimens were positive for at least one bacterium. Bacterial detection rates were: pneumococcus (37.4%); Staphylococcus aureus (28.7%); Haemophilus influenzae (26.4%); Moraxella catarrhalis (23.2%). Influenza A detection was not associated with detection of pneumococcus, S. aureus, or H. influenzae. Influenza B detection was associated with detection of H. influenzae, while specimens positive for RSV were also positive for pneumococcus. 

Conclusion: The sensitivity and specificity of the Diatherix panel for detecting Influenza A, the most clinically relevant of the viral pathogens, was high. It is unknown whether bacterial co-detection represents colonization or co-infection. Multiplex panels improve diagnostic yield for ILI.

John Arnold, MD1, Wei-Ju Chen, PhD2, Mary Fairchok, MD3, Christina Schofield, MD FACP4, Tahaniyat Lalani, MBBS, MHS5, Patrick Danaher, MD6, Michael Rajnik, MD7, Erin Mcdonough, BS8, Deepika Mor, MS9, Michelande Ridore, BA10, Timothy Burgess, MD, MPH7, Leslie Malone, MS, MB(ASCP)11, Elena Grigorenko, PhD11 and Eugene Millar, PhD9, (1)Department of Pediatrics, Naval Medical Center San Diego, San Diego, CA, (2)Infectious Disease Clinical Research Program, Uniformed Services University, Rockville, MD, (3)Infectious Disease Clinical Research Program, Tacoma, WA, (4)Madigan Army Medical Center, Tacoma, WA, (5)Naval Medical Center Portsmouth, Portsmouth, VA, (6)San Antonio Military Health System, Fort Sam Houston, TX, (7)Walter Reed National Military Medical Center, Bethesda, MD, (8)Naval Health Research Center, San Diego, CA, (9)Infectious Disease Clinical Research Program, Rockville, MD, (10)Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Rockville, MD, (11)R&D, Diatherix Laboratories, Inc., Huntsville, AL


J. Arnold, None

W. J. Chen, None

M. Fairchok, None

C. Schofield, None

T. Lalani, None

P. Danaher, None

M. Rajnik, None

E. Mcdonough, None

D. Mor, None

M. Ridore, None

T. Burgess, None

L. Malone, Diatherix Laboratories, Inc.: Employee, Salary

E. Grigorenko, Diatherix Laboratories, Inc: Employee, Salary

E. Millar, None

Findings in the abstracts are embargoed until 12:01 a.m. EDT, Oct. 8th with the exception of research findings presented at the IDWeek press conferences.

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