Immunology Virology Quality Assessment Laboratory

The DHVI-IVQA Center Core Laboratory offers College of America Pathologist-(CAP) and Clinical Laboratory Improvement Amendments-(CLIA) accredited immunologic and viral load assay platforms including flow cytometry acquisition time, CD4/CD8 Immunophenotyping, HIV-1 RNA Viral load, HIV-1 2+ O EIA, HIV p24 (non-ICD) and Western Blot determinations.

IVQAC Core Laboratory procedures and assays are performed under Good Lab Practices (GLP). These activities include non-human primate SIV viral load, PBMC processing from Leukopaks, Sterility testing for bacteria/fungi, Mycoplasma and/or Endotoxin testing, and Elutriation processing for cell separation.

Download IVQAC informational poster

Facility Leadership

  • Director, Tom Denny
  • Manager, Ambrosia Garcia

SARS-CoV2 ELISA Antibody Assay
The enzyme immunoassay (ELISA) provides semiquantitative in vitro determination of human antibodies of the immunoglobulin class IgG against SARS-CoV-2 in serum, EDTA, heparin or citrate plasma to support the diagnosis of SARS-CoV-2 infection and constitutes a supplement to the direct pathogen detection.

SARS-CoV2 Abbott PCR
The Abbott RealTime SARS-C0V-2 assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acids from the SARS-CoV-2 in nasopharyngeal (NP) and oropharyngeal (OP) swabs from patients who are suspected of COVID-19 by their healthcare provider.

Clinical Flow Cytometry Acquisition
Time slots are offered on either Becton Dickinson FACSCalibur or FACSCanto multicolor flow cytometers for acquisition and analysis of research and clinical samples. Both instruments are kept and maintained according to CAP and GLP guidelines for 1 to 4 color Immunophenotyping

SIV Viral Load
Non-human Primate, SIV viral load testing is performed under GLP, utilizing an automated Qiagen System/Pathogen Midi Kit (96) and ABI’s StepOne Plus Quantitative Real-Time PCR platform with primers and probes that target the GAG region of the SIV, SHIV and SMM variants with intact GAG sequences detected. This assay has been validated for EDTA rhesus plasma and requires 600 µL of sample. The lower limit of detection for this SIV assay is 250 copies/mL. For sensitivity needs below that, our ultrasensitive SIV VL assay has a lower limit of detection of 50 copies/mL from a 2mL sample size.

HIV-1, 2+O EIA Ab 
HIV1, 2 + O serology testing is determined qualitatively using the Bio-Rad HIV-1, 2 + O EIA platform.

HIV-1 Western Blot (WB)
WB confirmatory assay is performed using a Bio-Rad Clinical Diagnostics kit. HIV acute disease staging (Fiebig staging) is also offered based on the results from both HIV-1 Ab and WB.

HIV-1 RNA Viral Load
HIV-1 RNA viral load is quantified using the Roche COBAS AmpliPrep /COBAS Taqman 48 system. It is a real-time PCR assay with a quantifiable range of 20 - 10,000,000 RNA copies/mL (HIV).

Sterility Testing for Bacteria/Fungi
This qualitative test involves direct inoculation of the test sample into two different types of media: Tryptic Soy Broth (TSB), also commonly referred to as Soybean-Casein digest, and Fluid Thioglycollate Media (FTM). Inoculated media is monitored for microorganism growth.

Sterility Testing for Mycoplasma
This qualitative test utilizes the MycoAlert® test kit to detect the presence of Mycoplasma.

Sterility Testing for Endotoxin
Testing is done using the Limulus Ameobocyte Lysate (LAL) Pyrogent® Plus Single Test Vial Gel Clot Assay. This qualitative assay has a sensitivity of 0.125EU/mL

Leukopak Processing
PBMCs are obtained, under GLP, through density gradient centrifugation and are assessed for viability and cell number, aliquoted, cryopreserved, and stored in vapor phase LN2 freezers. 

Elutriation Processing
Elutriation utilizes a counter flow centrifugation procedure for separation of cell populations on a large scale.  Separation is based on cell size, shape, and density to serve the analysis needs of researchers.

DHVI-IVQA Data Management Plan

Current approved base rates are listed in CoreResearch@Duke (Core D-0049)

All requests must be submitted through CoreResearch@Duke (Core D-0049)

Submitting a Grant or Contract Proposal?

DHVI Shared Resource Facilities offer a wide-range of state-of-the-art Biocontainment facilities, instrumentation and services to support research initiatives in the areas of Vaccine Immunology, Immune Reconstitution, Host Pathogen Interaction, and Emerging Infectious Disease and Biodefense. 

Our facility directors and financial management team can assist you in preparing grant/contract proposals by providing letters of support, fee structures, project quotations, and descriptions of available technology and resources. Please contact the specific facility Director or Manager, or send an inquiry to the DHVI Shared Resources Scientific Director.