# Enhancing the Capacity and Capability of Human Food and Environmental Testing Laboratory at the Texas Department of State Health Services: Microbiology Capability/Capacity Development

> **NIH FDA U19** · TEXAS STATE DEPT OF HEALTH SERVICES · 2020 · $121,305

## Abstract

Project Summary 
Discipline A Microbiology, Track 5- Cyclospora Capability/Capacity Development 
The Texas Department of State Health Services (DSHS) Laboratory Services Section (LSS) 
works in conjunction with the Food and Drug Administration (FDA), the Centers for Disease 
Control and Prevention (CDC), and the state regulatory body, DSHS Consumer Protection 
Division (CPD), to ensure food and food products in Texas are safe. Cyclosporiasis, an 
intestinal illness caused by Cyclospora cayetanensis has increasingly been the source of 
outbreaks and significant sporadic illness in Texas. For this reason, DSHS LSS and CPD are 
interested in testing human food products for the presence of Cyclospora cayetanensis using 
real-time PCR for rapid and sensitive detection. The long-term goal is for this process to be a 
part of a routine surveillance test on food and environmental samples. 
 An implementation plan has been developed to purchase equipment, train staff, modify 
the laboratory information management system, evaluate and validate testing methodology, and 
demonstrate competency through proficiency testing. DSHS LSS will then work with CPD to add 
Cyclospora cayetanensis to the Sample Collection and Analysis Project of the Microbiology 
Human Food Testing Track. LSS will also work with the DSHS Infectious Disease and Control 
Unit and the DSHS Texas Rapid Response Team during outbreak investigations of Cyclospora 
cayetanensis in human food. 
 The LSS Consumer Microbiology Team (CMT) and Molecular Biology Team (MBT) will 
be performing procedures in methods following the FDA Bacteriological Analytical Manual 19b: 
Molecular Detection of Cyclospora cayetanensis in Fresh Produce Using Real-Time PCR. LSS 
will continue to follow FDA guidance for proper sampling and laboratory data documentation 
and participate in annual proficiency tests (PT) for work performed under this project. LSS will 
stay committed to its 20.88 agreement with the FDA and will attend the annual LFFM Face-to- 
Face meeting to ensure continued collaboration between LSS and FDA. 
 This project will strengthen and improve the collaboration of surveillance testing activities 
already established between the FDA and our state and local partners improving the ability of 
DSHS to respond to a large-scale threat to the nation's food supply.

## Key facts

- **NIH application ID:** 10174176
- **Project number:** 1U19FD007080-01
- **Recipient organization:** TEXAS STATE DEPT OF HEALTH SERVICES
- **Principal Investigator:** Rachel C. Lee
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $121,305
- **Award type:** 1
- **Project period:** 2020-09-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10174176

## Citation

> US National Institutes of Health, RePORTER application 10174176, Enhancing the Capacity and Capability of Human Food and Environmental Testing Laboratory at the Texas Department of State Health Services: Microbiology Capability/Capacity Development (1U19FD007080-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10174176. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*