Verification of Infectious Disease Molecular Assays: A Self-Study Module

Nucleic acid amplification tests are increasingly performed in clinical and public health laboratories in the investigation of infectious disease. They are also used extensively in the Laboratory Response Network to detect agents of bioterrorism. The 2003 revisions to the CLIA regulations included requirements for the establishment and verification of performance specifications for molecular assays. This intermediate-level program will provide the learner with information on infectious disease molecular assay verification procedures and processes. The program begins by listing and defining the CLIA requirements, and continues by providing guidance and suggestions on how to comply. The program describes how one laboratory team established the performance specifications for an in-house developed assay and verified the manufacturer’s performance specifications for an FDA-cleared assay. It concludes with suggestions on how to report results from in-house developed assays that use analyte specific reagents (ASRs). Exceptions to the CLIA requirements that may apply to public health laboratories during public health emergencies will be outlined. The program is delivered using a documentary style. Learners will hear from experts in the field of molecular diagnostics who will answer the difficult questions that many laboratory scientists have about verifying molecular assays. Learners may test their comprehension and competency by completing a post test.

“Malaria: An On-line Resource” from Royal Perth Hospital

An online resource for malaria, in English, French or Spanish, including information on diagnosis, prophylaxis, treatment, and history, as well as case presentations, and a self-test module, presented by the Royal Perth Hospital, in Western Australia.

Pictorial Keys to Arthropods, Reptiles, Birds, and Mammals of Public Health Significance

This material for identification of disease vectors is available online in PDF format from the CDC’s Environmental Health Services.

NAAT online learning modules: “Gaining Efficiencies in Laboratory Workflow” and “Managing Various Sample Types”

Two online learning modules are available: Module one is “Gaining Efficiencies in Laboratory Workflow.” This presentation focuses on the procedures involved with nucleic acid amplification testing (NAAT) in an infectious disease testing laboratory (microbiology). The goal of the presentation is to examine and review the procedures involved with producing a NAAT test, from sample collection through archiving patient results. Evaluating procedures beyond performing the assay can be beneficial in identifying new areas to improve laboratory performance and turnaround time. In particular, areas in which laboratory automation could be considered for improving laboratory workflow and efficiency are discussed.

Module two is “Managing Various Sample Types.” This educational module is the second in a series on clinical testing for CT and GC with NAATs. The goal of this second module is to review the different sample types that can be used with NAATs with a particular focus on the use of urine samples and novel sample types such as vaginal swabs and liquid PAP transport (LPT) samples. Understanding the importance of specimen quality and the differences in sample collection, transportation, handling and associated problems can be key to increasing laboratory efficiency and assuring the highest quality testing results.

Continuing education credits (CEUs) are available through the publisher.

Recognizing Waterborne Disease and the Health Effects of Water Pollution

This reference guide provides access to clinically relevant information and specialized educational resources for practicing physicians in several major areas of increasing importance and growing concern among those responsible for protecting public health and water safety, including basics of water safety and protection, evaluation and management of disease resulting from waterborne pathogens, evaluation and management of disease resulting from chemical contaminants, and evaluation and management of water-related disease in susceptible populations and risk communication. CME credit is available through the publisher beginning in August 2008.

A module on “Physician Preparedness for Acts of Water Terrorism” is also available.

STD Clinical Intensive Course online

Topics covered in this course include the clinical approach to STD patients, syphilis, gonococcal infections, chlamydial infections, human papillomavirus infections, herpes simplex virus infections, the syndromic approach to the management of STDs, and viral hepatitis. CME credits or Nursing contact hours (CEUs) are available from the publisher through April 2010.