Clinical Laboratory Core

 

Our Mission:

The Clinical Laboratory Cores (CLC) will coordinate access to world-class laboratory expertise, testing, training, specimen repositories and Good Clinical Laboratory Practices (GCLP) to HIV researchers where specialized laboratory services are essential to measuring study outcomes

Services:

  • To coordinate, promote, and facilitate faculty access to established and emerging laboratory methods essential for studying HIV pathogenesis, treatment, and prevention.
  • To provide consultative support for effective incorporation of laboratory methods into diverse research programs with a focus on junior and new-to-HIV faculty investigators
  • biomarker specimen repository for the storage, cataloguing and testing of biological specimens, including access to the clinical data associated with those specimens
  • Making services of laboratories available from other CFARs. Information about the laboratory services offered by each of the CFAR’s can be accessed by clicking “Lab services from other CFARs”  link menu page on left
  • Provide access to current and past research information. The core maintains a Data and Sample Set Database that can be accessed under “resources” “HIV related data and sample sets”

Training and Quality:

  • Provide training, mentoring, and courses for domestic and international investigators and students on state-of-the-art laboratory assays related to HIV so they can become proficient in performing relevant laboratory assays for the successful conduct of their research
    • In collaboration with the JHU-ICTR Drug Discovery and Development Core, sponsors a yearly symposium that highlights successful clinical-laboratory collaborations resulting from use of CFAR and ICTR Core services.
    • In collaboration with the JHU-ICTR Drug Discovery and Development Core, conducted a course on Laboratory Methods for Translational Scientists. The purpose of the course is to provide basic knowledge about commonly used laboratory methods applied in support of clinical investigation. This course is offered annually.
    • Provide one-on-one laboratory training in core labs
  • Train investigators in laboratory Quality Control/Quality Assurance (QC/QA), Good Clinical Laboratory Practices (GCLP) and Clinical Laboratory Improvement Amendments (CLIA) requirements to assist them in setting up an assay for clinical testing.

Our Core Laboratories *:

*Pharmacology Laboratory Program (CPAL)

  • Specializes in the development, validation and implementation of bioanalytical tools to assess drug pharmacokinetics (PK) and pharmacodynamics (PD).
  • Analytical platforms available in the CPAL include, but are not restricted to, liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analysis, high performance liquid chromatographic-fluorescence detection approaches, radioisotopic detection/gamma counting, enzyme-linked immunosorbent assays (ELISAs), cell counting and enzyme assays.
  • Expertise in the development and validation of LC-MS/MS assays for anti-infective quantification in a variety of biological matrices
  • Can assist in the development and analysis of data to assess the pharmacokinetic parameters of drug distribution and clearance, as well as assist in adherence assessment based on previously documented studies regarding threshold ARV concentrations. 

*Repository Laboratory Program

  • Repository needs assessment consultation
  • Specimen collection (phlebotomy)
  • Specimen processing including plasma/serum separation, aliquotting, freezing
  • Cryopreservation
  • Biorepository & sample storage
  • Inventory management

*Immunology Laboratory Program

  • Immunology needs assessment  & study design consultation
  • CD4/CD8 counts (among other specific flow cytometric assays)
  • Cell Sorting
  • Cytokine analysis (MSD platform)
  • Intracellular RNA, protein staining
  • CLIA-certified & College of American Pathologists certified

*Virology Laboratory Program

“Infectious Disease Laboratory”

  • Viral Diagnostic Testing
  • Quantitative viral outgrowth assay
  • Quantitative cell-associated HIV-1 DNA & mRNA (ddPCR)
  • Standard HIV-1 genotyping
  • Measurment of soluble markers of inflammation and immune activation
  • CLIA-certified

“Viral Diagnostic Laboratory”

  • Phlebotomy
  • Blood processing
  • HIV serological testing
  • HIV RNA quantification
  • DNA extraction
  • CLIA certified

*Drug Development

  • Antiretroviral Drug Concentration
  • ARV Imaging
  • Collaboration with JHU-ICTR Drug Discovery and Development Core

Attention: 

​The CFAR Laboratory Core now has in its Virology Lab the availability to HIV researchers the use of Quanterix Simoa Equipment that can detect extremely low-levels of established disease biomarkers, capturing concentrations down to the femtogram/mL level, and as a result monitor small changes in protein concentrations to accurately measure biomarkers associated with disease progression. In addition, small sample volume requirements allow you to conserve valuable samples.  Those wishing to use this equipment are asked to provide their own consumables and have a certain understanding using this type of equipment.  For more information, please contact Dr. Deborah Persaud at dpers@jhmi.edu. Those wishing to use the equipment are asked to make a formal request through the CFAR web page by clicking the “Request CFAR Services” button.

Other services of interest to the HIV investigator:

The Johns Hopkins NIMH Center: comprises an interdisciplinary research team who has pooled their talents to study the nature of HIV-associated neurocognitive disorders (HAND). Their aim is to translate discoveries of the pathophysiological mechanisms into novel therapeutics for HAND.

https://www.hopkinsmedicine.org/neurology_neurosurgery/research/labs/jhu_nimh/center_cores/

NIMH Center Biomarker Core: 1) Assist in the development and monitoring of surrogate markers for HIV-associated neurocognitive disorders (HAND) 2) To provide mentorship and consultation for Neuro-AIDS researchers in the development of clinically useful surrogate markers for HAND and to validate these as predictive and associative markers for cognitive impairment and as surrogate markers for therapeutic effectiveness 3) Assist in the development of small molecule therapeutics by providing consultation on pharamcokinetic/pharmacodynamic considerations for drug development, and conducting pharmacokinetic and analysis of potential drugs and drug metabolites.

https://www.hopkinsmedicine.org/neurology_neurosurgery/research/labs/jhu_nimh/center_cores/surrogate_markers_core.html

For a lab service request or consultation:

Click on “Request CFAR Service” button on left

Please help us:

Remember to acknowledge the CFAR in your publications, abstracts, grant proposals, and presentations.
Continued funding from NIH for the JHU CFAR depends on evidence that we are providing added value to HIV research being done at Johns Hopkins.

If you receive any kind of support from the CFAR, please include an acknowledgement in your publications, presentations, etc. by using the citation examples available here.

If any of the support was for Laboratory specific topics and you have published, presented or submitted a proposal, please send a link to Curt Reynolds (cjreyn@jhmi.edu) so that we can track and publicize HIV research at JHU.