Lab Research Activities

Laboratory Developed Tests

These tests were developed using Analyte Specific Reagents for clinical purposes. As a regulated CLIA certified laboratory, we are qualified to perform high-complexity testing of this nature.

• Atypical Pneumonia Panel PCR
• Pan-Ehrlichia / Anaplasma phagocytophilum PCR
• Pneumocystis jirovecii PCR
• SARS CoV-2 PCR
• Chlamydia trachomatis/Neisseria gonorrhoeae PCR

Expertise and Support for Clinical Trials

In the last 25 years, the Infectious Diseases Laboratory has participated in over 10 major clinical studies in Louisville, Kentucky

2021 – 2022: EUROIMMUN® Powassan virus serological study
In 2021, the Infectious Diseases Laboratory was approached to participate in the performance evaluation of the Euroimmun® Powassan Virus ELISA lgG and lgM antibody test. The ID Laboratory was asked to save retrospective and prospective samples from the tick-borne diseases panel as part of the evaluation, and then to participate in a sub-study of seroprevalence for Powassan Virus in the Louisville Metropolitan area. The ID Laboratory screened 250 retrospective and 100 prospective samples for evidence of antibodies to Powassan virus.

2017: IMMUVIEW®
In 2017 the Infectious Disease Laboratory participated in a performance evaluation of the ImmuView® S. pneumoniae and L. pneumophila Urinary Antigen Test. The ID Laboratory was one of the sites chosen by SSI Diagnostica to obtain precision and accuracy data for premarket notification (510K) submission to the FDA for a combination urine antigen test. The ID Laboratory tested 500 samples (from the ID Biorepository) and 100 CSF samples sent by SSI Diagnostica. All results were maintained in an excel spreadsheet and worksheets, plus images of the test strips and instrument readouts were provided to SSI Diagnostica (Edelstein PH et al., 2020).

2010 – 2016: RETOS I & II
“Effectiveness of Empiric Antiviral Treatment for Hospitalized Community Acquired Pneumonia (CAP) During the Influenza Season (U18)”. A prospective, randomized, unblinded clinical study of hospitalized patients with acute LRTI (Lower Respiratory Tract Infection) including suspected CAP admitted in one of nine institutions in Louisville, KY (rapid empiric treatment with oseltamivir [RETOS]). The University of Louisville Infectious Diseases Laboratory tested batched specimens using molecular techniques for the diagnosis of respiratory pathogens, including viral, atypical, and bacterial.

2008 – 2012: Severe Influenza Pneumonia Surveillance (SIPS)
The SIPS (Severe Influenza Pneumonia Study) included 400 nasopharyngeal swabs tested for multiple viral and atypical pneumonia pathogens at the University of Louisville Infectious Disease Laboratory, including influenza A (H1 and H3 subtypes), influenza B, 2009 H1N1 influenza A, parainfluenza viruses 1, 2, and 3, respiratory syncytial viruses A and B, adenovirus, rhinovirus, and human metapneumovirus. The Luminex® xTAG respiratory viral panel multiplex polymerase chain reaction (PCR) assay was used for viral identification. The 2009 H1N1 influenza A virus was tested via a subsequent PCR if the Luminex® testing resulted in “untypable influenza A virus”.

2001 – 2004: Abbott
Abbott was testing the efficacy of ABT-773 (cethromycin). The Infectious Diseases Laboratory provided them 600 oropharyngeal and serum samples tested for the presence of M. pneumoniae and C. pneumoniae by PCR. In addition, serological studies were performed for Mycoplasma (EIA) and Chlamydia (IFA) on these patients.

2002: Aventis
A study in which serological studies and PCR assays for M. pneumoniae and C. pneumoniae were performed to assess efficacy of a new antibacterial for atypical pneumonia pathogens.

1996 – 2003: Bristol Myers Squibb
Two different studies were sponsored by Bristol Myers Squibb to gain information about the antibiotic gatafloxacin. The first study conducted from (1996-1997) within the United States, for which approximately 1000 specimens collected from patients with pneumonia were tested using the Infectious Diseases lab-developed test for atypical pneumonia, serology, urine antigen and culture for Mycoplasma pneumoniae. The second study conducted from (2001-2003) included three sites within the US and 3 sites outside the US, performing the sample set of assays on over 3000 respiratory specimens collected.

1996 – 1998: Parke-Davis
“Clinafloxacin vs Ceftriaxone in the Treatment of Hospitalized Patients with Community-Acquired Pneumonia”. In an open-label, phase 3, randomized, multicenter study, clinafloxacin (200 mg/d) was compared to ceftriaxone (2 g/d; with or without erythromycin) in 527 patients with acute community-acquired bacterial pneumonia (CAP). A battery of laboratory tests was performed which included PCR for Mycoplasma pneumoniae, Chlamydia pneumoniae, and Legionella pneumophila; urinary antigen for Legionella; culture and DFA for Legionella; culture for C. pneumoniae; and serological studies for M. pneumoniae, C. pneumoniae, and L. pneumophila.

Capacity to Generate and Disseminate Knowledge

Recent Publications

As part of a university dedicated to research the dissemination of knowledge from clinical trials improves patient care in our community and beyond.

February 2023
Performance of a SARS-CoV-2 RT-PCR Assay with Non-Traditional Specimen Types
Marimuthu, Subathra; Aliesky, Holly; Ness, Heather; Sheikh, Daniya; Rashmit, Sathya; Balcom, Dawn; and Wolf, Leslie A.

April 2021
Development of a real-time Reverse-Transcription PCR for SARS CoV-2 on the Luminex ARIES® Platform
Marimuthu, Subathra; Aliesky Holly; Connelly, Brigid; Malik, Danial Arsalan; and Wolf, Leslie A

December 2020
Development and Evaluation of a Fully Automated Molecular Assay Targeting the Mitochondrial Small Subunit rRNA Gene for the Detection of Pneumocystis jirovecii in Bronchoalveolar Lavage Fluid Specimens
Baoming Liu, Marissa Totten, Saman Nematollahi, Kausik Datta, Warda Memon, Subathra Marimuthu, Leslie A. Wolf, Karen C. Carroll, and Sean X. Zhang.

August 2020
Performance of the ImmuView and BinaxNOW assays for the detection of urine and cerebrospinal fluid Streptococcus pneumoniae and Legionella pneumophila serogroup 1 antigen in patients with Legionnaires’ disease or pneumococcal pneumonia and meningitis.
Edelstein PH, Jørgensen CS, Wolf LA.

May 2020
Detection of Ehrlichia spp. and Anaplasma phagocytophilum in whole blood specimens using a duplex real-time PCR assay on the ARIES instrument.
Wolf LA, Marimuthu S, Summersgill JT.

March 2019
Development of a Real-time PCR assay for Pneumocystis jirovecii on the Luminex ARIES® Platform
Marimuthu, Subathra; Ghosh, Kuldeep; and Wolf, Leslie A

April 2018
A Randomized Study Evaluating the Effectiveness of Oseltamivir Initiated at the Time of Hospital Admission in Adults Hospitalized with Influenza-Associated Lower Respiratory Tract Infections (RETOS).
Ramirez J, Peyrani P, Wiemken T, Chaves SS, Fry AM.

April 2018
Real-Time PCR Detection of Mycoplasma pneumoniae, Chlamydia pneumoniae and Legionella pneumophila in Respiratory Specimens Using the ARIES® System
Marimuthu, Subathra; Wolf, Leslie A.; and Summersgill, James T

October 2017
Preliminary Evaluation of a lytA PCR Assay for Detection of Streptococcus pneumoniae in Urine Specimens from Hospitalized Patients with Community-Acquired Pneumonia.
Marimuthu, Subathra; Summersgill, James T.; Ghosh, Kuldeep; and Wolf, Leslie A

December 2012
Incidence of respiratory viruses in patients with community-acquired pneumonia admitted to the intensive care unit: results from the Severe Influenza Pneumonia Surveillance (SIPS) project.
Wiemken T, Peyrani P, Bryant K, Kelley RR, Summersgill J, Arnold F, Carrico R, McKinney WP, Jonsson C, Carrico K, Ramirez J.

April 2003
Microbiological efficacy of ABT-773 (cethromycin) for the treatment of community-acquired pneumonia due to Chlamydia pneumoniae.
Hammerschlag MR, Reznik T, Roblin PM, Ramirez J, Summersgill J, Bukofzer S.

July 2002
Distribution of Legionella species and serogroups isolated by culture in patients with sporadic community-acquired legionellosis: an international collaborative survey.
Yu VL, Plouffe JF, Pastoris MC, Stout JE, Schousboe M, Widmer A, Summersgill J, File T, Heath CM, Paterson DL, Chereshsky A.

A Randomized, Double-Blind, Multi-Center, Comparative Study of Oral Gatifloxacin vs Trovafloxacin in the Treatment of Community-Acquired Pneumonia.uly
An Open-Label, Multicenter, Non-Comparative Phase II/III Study of Oral Gatifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia

Research Posters and Presentations

Each year the Infectious Diseases Laboratory presents at numerous conferences, workshops, meetings, and symposiums. In the past our team has presented at Research! Louisville and other local conferences.

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