Biorepository Research Activities

Laboratory Tests in Development

These tests are currently being developed for use in the ID Clinical Laboratory. Our team is continuously trying to expand the testing services we offer to meet client needs in our community.

• Streptococcus pneumoniae PCR Assay for various sample types
• Streptococcus pneumoniae Serotyping PCR Assay and Serology (Quellung reaction)

Expertise in Funded Research Projects

The ID Laboratory has collaborated closely with the Division of Infectious Diseases Research team and other groups to support large population-based, epidemiological, and clinical studies in Louisville, Kentucky, and Southern Indiana.

February 2023-May 2023: Prevalence of SARS-CoV-2 Colonization and Humoral Immunity
A collaborative effort between the University of Louisville Center for Predictive Medicine (CPM) and the Center for Excellence in Infectious Diseases (CERID) to launch a longitudinal cross-sectional prospective study to measure the prevalence of colonization by SARS-CoV-2 and other respiratory viruses using nasopharyngeal Polymerase Chain Reaction (PCR) among asymptomatic and symptomatic cases and to determine the seroprevalence of SARS-CoV-2 antibodies using assays and neutralizing titers among adults 18 years and older.
Past studies estimating the seroprevalence of SARS-CoV-2 antibodies are very inconsistent. Antibodies typically measured by research laboratories target the spike (S) protein, a segment of the spike protein called the receptor binding domain (RBD), and the nucleocapsid (N) protein. S or RBD antibodies may be present whether an individual was vaccinated or previously infected with SARS-CoV-2. N antibodies are characteristic of infection since COVID-19 vaccines induce immunity only to the S protein; the presence of N antibodies can therefore be used to distinguish infection-induced from vaccine-induced immunity.
Division of Infectious Diseases CERID team recruited, screened, enrolled the participants, and collected necessary samples. Nasopharyngeal swabs were collected at Visit 1, at Visit 2 (7 days +/- 3 days) after the initial visit, and at Visit 3 (14 days +/- 3 days) after the initial visit. The nasopharyngeal swab was tested on the VERIGENE® Respiratory Pathogen Flex Nucleic Acid panel and the Luminex ARIES® SARS-CoV-2 PCR test at the Infectious Diseases Clinical Laboratory and Biorepository. Samples for SARS-CoV-2 antibody determination and neutralizing titers were tested at the CPM.

January 2023-Present: A 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) Study
A phase 4 multicenter effectiveness study conducted at investigator hospital sites across the United States. This study is a post-approval evaluation of the effectiveness of a 20-valent pneumococcal conjugate (20vPnC) vaccine against vaccine-type (VT) radiologically confirmed community acquired pneumonia (RAD+CAP) in adults ≥ 65 years of age using a test negative design. The primary objective of the study is to determine vaccine effectiveness (VE) of 20vPnC against RAD+CAP caused by the 7 additional serotypes contained in 20vPnC beyond licensed 13-valent pneumococcal conjugate vaccine (13vPnC; serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F) plus 15C among adults ≥65 years of age. Unlike for pediatric 13vPnC use, where immunization coverage is high, adult 13vPnC coverage is consistently <80% among US adults aged ≥65 years. As such, this provides an opportunity for determining vaccine effectiveness while controlling for potentially confounding variables in the analysis.
The UofL Division of Infectious Diseases CERID team collected urine from study participants. The samples were processed, aliquoted, stored, and shipped to the study sponsor by the ID Biorepository. In addition, Streptococcus pneumoniae isolates were grown, stored, and shipped to Baylor College of Medicine for confirmation, serotype, or serogroup testing and antibiotic resistance. Aliquots and isolates were also stored on-site in the Infectious Diseases Biorepository.

2022-Present: Pfizer Meningococcal Carriage Study
A study designed to determine the baseline carriage rates in students upon arrival at the University of Louisville and to determine longitudinal carriage and transmission dynamics over the initial period of study. This will not only provide insight into carriage rates in a post-pandemic setting but will be the first study to longitudinally measure carriage in a US college population and determine transmission and acquisition events. Posterior oropharyngeal swabs will be collected and placed in a medium containing skim milk, tryptone, glucose, and glycerin (STGG) at days 0-1, day ~28, and day ~84, refrigerated, transported to the ID Biorepository, aliquoted, frozen, and then shipped to Pfizer’s central laboratory to be tested.

2022-Present: Janssen Johnson & Johnson RSV Vaccine Study
A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older. The ID Biorepository plays a key role in the study by receiving multiple sample types prior to administration of the vaccine and at various follow up visits for all participants. In addition, those sample types are also collected from participants who exhibit signs and symptoms of respiratory disease post vaccine. For signs and symptoms participants, a nasopharyngeal swab (NP) was tested by the Biorepository personnel for numerous respiratory targets using the Biofire Filmarray Respiratory Panel®. The panel results are forwarded to the study sponsor. All remaining NP samples, serum, whole blood in PAX gene tubes were aliquoted and stored. All stored samples were frozen and subsequently shipped to the J&J central laboratory. If sputum was received, the sample was aliquoted and sent to the central laboratory to be tested.

2021-December 2022: Janssen Johnson & Johnson Vaccine Study
A comprehensive study sponsored by Janssen Johnson & Johnson to evaluate an investigational vaccine (Ensemble COVID-19) for the prevention of COVID-19. The ID Biorepository received whole blood, serum, and mid-turbinate (mt) nasal samples. Mt-nasal samples were tested at the ID clinical laboratory and stored to send to Covance laboratory. Serum was aliquoted into tubes and whole blood in PAX gene tubes and saliva were stored. All the stored frozen tubes were shipped to Covance lab. Samples were collected during visit one and various follow up visits for all the participants.

2021-Present: COVID-19 Breath Analysis Study
An NIH-funded project between the University of Louisville Vaccine & International Travel Clinic, the Department of Chemical Engineering and the Department of Anesthesiology and Perioperative Medicine to develop a non-invasive handheld tool to detect COVID-19 (SARS CoV-2) in breath samples. The ID Clinical Laboratory participated by testing NP samples collected by the Travel Clinic for SARS CoV-2 by PCR. Breath samples were also collected into a bag or tool. The breath metabolite was transferred from the bag into either chip or cartridge. The metabolite was then eluted from the chip, cartridge, and tool by the ID Biorepository using an organic solvent then further analyzed at the UL Bioengineering Laboratory.

2020-Present: Post COVID-19 Research Clinic
A multi-disciplinary collaboration between the Louisville community and the Center of Excellence for Research in Infectious Diseases (CERID) at the University of Louisville Division of Infectious Diseases to study the long-term health consequences of COVID-19. Our principal investigator, Jiapeng Huang, MD, from the Department of Anesthesiology & Perioperative Medicine, received funding from Gilead Sciences to study cardiovascular and pulmonary long-term effects of COVID-19 using point-of-care ultrasound. The ID Biorepository received whole blood, plasma, serum, and urine samples to be processed and stored on-site. Some samples were shipped off-site to another laboratory for further studies.

2019-Present: Ex-vivo Lung Perfusion Study
A collaboration with the UofL Cardiovascular Institute (CII) to explore improved methods for studying diseased lungs, new treatments, and therapies for inflammatory lung disease. The Ex-vivo Lung Perfusion (EVLP) system is used not only for research to extend the viability of donated lungs, but explore new focus areas related to pneumonia, COPD, and cancer. A pig model of ventilator-associated pneumonia was developed by establishing an effective dose of an organism commonly associated with severe pneumonia. The ID Laboratory grew Staphylococcus aureus ATCC #12600 and prepared inoculums for the CII team. Baseline, Day 3, Day 6, Day 9, and Post EVLP BAL samples were submitted to the ID laboratory and analyzed for growth of S. aureus. Reports of growth were generated by the ID laboratory staff after each BAL submission.

2019-2020: The City of Louisville Diarrhea (CLOUD) Study
The City of Louisville Diarrhea (CLOUD) study was an active surveillance study sponsored by Pfizer to determine the burden of incidence of diarrhea infection attributed by Clostridioides difficile in a multi-hospital system. The ID Biorepository tested 1,408 stool samples for C. difficile by the Alere Techlab® Quikchek method. Positive samples were stored, and aliquots were shipped to a Pfizer laboratory in NY for further testing. A non-funded internal pilot study was also conducted using 30 samples at the ID Biorepository to determine the incidence of co-infection using the same C. difficile positive samples. Aliquots of positive stool samples are stored on-site.

2019-2020: Urinary Antigen Development (UAD) II and 2014-2016: Urinary Antigen Development (UAD) I
Urinary antigen development I (UAD I) and Urinary antigen development II (UAD II) studies were sponsored by Pfizer. Two studies were performed to determine the serotypes of Streptococcus pneumoniae in adults 18 years and older with radiographically confirmed acquired pneumonia. Urine samples were processed and aliquoted into tubes, stored, and shipped to Pfizer by the ID Biorepository. Streptococcus pneumoniae isolates were grown, stored, and shipped to Baylor College of Medicine and Ableilung me Mikrobiolgie, Streptokokken Nationales Referenzzentrum, Aachen, Germany for serogroup testing. Aliquots and isolates (UADII) were also stored on-site.

2014-2016: HAPPI
Population-based study to define the clinical and economic burden of Pneumococcal Pneumonia in Hospitalized Adult Patients in Jefferson County, Kentucky (HAPPI). Sponsored by Pfizer, urine samples were processed, aliquoted into tubes, stored, and shipped to Pfizer by the ID Biorepository.

Capacity to Generate and Disseminate Knowledge

Recent Publications

ID Biorepository prioritizes the dissemination of knowledge to improve patient outcomes and care within the community.

October 2023
Identification of a marker of infection in the breath using a porcine pneumonia model
Katsaros, Gianna; Ansley Smith, Susan; Shacklette, Sienna; Trivedi, Jaimin; Garr, Stephanie; Wolf Parrish, Leslie; Xie, Zhenzhen; Fu, Xiao-An; Powell, Karen Powell; Pantalos, George; and van Berkel, Victor

December 2020
Implementation of the University of Louisville COVID-19 Biorepository: Experiences from the Center of Excellence in Infectious Diseases (CERID)
Balcom, Dawn; Wolf, Leslie A; Marimuthu, Subathra; Johnson, William; Malik, Danial; Dhakal, Chet; Nathala, Pavani; Abbas, Mohammed; Hardeep Singh, Sahaj; Haddad, Basel; Elbeblawy, Rafik; Deepti, Fnu; Ali, Ahmed; Exposito Gonzalez, Evelyn; and Carrico, Ruth

October 2019
Association of Urine Levels of C-Reactive Protein with Clinical Outcomes in Patients with Pneumonia: A Pilot Study
Marimuthu Subathra, Salunkhe, Vidyulata; Furmanek, Stephen P; and Wolf, Leslie A.

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

Research Posters and Presentations

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