Immunodiagnostic Laboratories (IDL), located in San Leandro, California, was founded in 1982, and rapidly established itself as a leader in innovative immunologic testing services.
Our commitment to excellence is reflected in our high level of technical proficiency and client-focused service. IDL also takes pride in its commitment to research and development of new technologies designed to complement currently available services.
IDL offers a broad range of specialty immunologic tests, including immunodeficiency, autoimmunity, neoplastic and infectious diseases. Expert consultation is available from our staff to aid in test selection and interpretation. At IDL, our goal is to provide our clients with timely, accurate, and dependable results. We look forward to working with you and welcome any comments and suggestions you may have regarding our services.
IDL provides comprehensive laboratory support for clinical trials. Sponsors may select from a wide variety of specialty or general laboratory tests or may work closely with the staff customizing new assays to fit their specific needs.
Our new Ultra-sensitive HIV-1 RNA/PCR test provides a marked improvement over currently available methodologies. With a dynamic range extending from a threshold of less than twenty copies of RNA/ml to greater than a million, the entire clinically important range is available to the clinician with every study. Assays do not have to be repeated with different tests during the course of therapy.
IDL is now performing a new test for Plasma RNA Detection. To find out more about this innovative testing, and to order a test kit, please click here.
Please click on one of the subjects below for more information about IDL and our services.
HIV-1 Plasma RNA Quantitation by
Polymerase Chain Reaction (PCR)
INDICATIONS
For the quantitative determination of HIV-1 RNA in human plasma as an aid in the prognosis of HIV disease and in assessing the efficacy of anti-retroviral therapy and vaccines.
DESCRIPTION
The human immunodeficiency virus (HIV) is recognized as the etiologic agent of acquired immune deficiency syndrome (AIDS). Until recently, monitoring of disease progression and assessment of clinical response to therapy have relied on a number of immunologic and virologic surrogate markers. Such markers have included CD4 lymphocyte cell count, serum HIV-1 p24 antigen (with and without immune complex dissociation), beta-2 microglobulin, neopterin, and quantitative microculture of peripheral blood mononuclear cells (PBMCs) and plasma. However, experience has shown limitations to the clinical application of these markers and has emphasized the need for more direct quantitation of viral load.
Recent studies have shown that viral RNA in plasma of HIV-1 infected individuals can be accurately and reproducibly quantitated by polymerase chain reaction (PCR) assay. Current methods are of sufficient sensitivity with the ability to detect as few or fewer than 20 RNA copies/ml thus enhancing the ability to more sensitively assess clinical samples.
Quantitative determination of plasma HIV-1 RNA levels are reported to be a more significant predictor of disease stage and clinical progression than other virologic surrogate markers, including CD4+ lymphocyte cell count, p24 antigen or neopterin, which reflect distal, later occurring consequences of HIV infection. Patients with higher levels of plasma HIV-1 RNA progress more rapidly to AIDS defining illnesses than patients with lower levels.
Plasma HIV-1 RNA levels decrease rapidly in patients beginning anti-retroviral therapies and rise again when therapy is discontinued or drug resistance develops; thus signaling disease progression even in some patients whose CD4 cell counts remain unchanged.
Quantitation of HIV-1 plasma RNA should be considered in the prognostic evaluation and serial monitoring of viral load in assessment of anti-retroviral drug therapy. This may be particularly significant in view of recent reports that rapid turnover of virus results in increasing viral diversity over time. This suggests that plasma viral monitoring be early and frequent if clinical impact is to be more significant.
TEST CODE/TEST NAME
2407 HIV-1 Plasma RNA Quantitation by Polymerase Chain Reaction (PCR)
METHOD
Polymerase Chain Reaction (PCR)
Clinical Trials
OVERVIEW OF SERVICES
Immunodiagnostic Laboratories (IDL) offers a comprehensive package of central laboratory services to support sponsors and clinical investigators conducting pharmaceutical clinical trials. Some of the services offered include:
Central laboratory supplies necessary for specimen collection, preparation and transport. Supplies are provided in visit-specific kits or in bulk.
Customized test profiles and test requisition forms
Customized reporting including panic values, abnormal flags, cumulative summaries, toxicity tables and trend analysis
Telephone alerts & delta flagging to highlight clinically significant abnormalities or pre-defined changes in lab parameters
Report delivery to sponsor and/or investigational site(s). Optional report formats including automated facsimile transmission or on-site reporting.
Complete instructions for investigational sites regarding specimen collection, preparation, and transport. Written instructions include a written Investigator Manual with summary charts of visit-specific laboratory specimen requirements.
Representation at investigators meeting for training of site personnel in specimen collection, preparation and shipping requirements
Electronic database construction, maintenance and transfer. Electronic database transfer options include tape, diskette and direct download.
Toll-free ongoing investigator support
Frozen specimen storage for study duration or pharmacokinetic studies
