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Friday, June 23, 2017
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CLS SUPPORT FUNCTIONS

Clinical laboratory activities performed by CLS include:

  • • Laboratory support for Clinical Trials (Phase I-III: including Grant Funded Projects and Pharmaceutical Trials)
  • • Training and Capacity Building in Clinical Laboratories in Africa
  • • Accreditation and audit support for laboratories
  • • Clinical Research (Non-Trial Academic)
  • • Infectious Disease Prevalence Testing
  • • Specialist Diagnostic and Monitoring Testing for Patients
  • • The CLS group has more than 10 years experience in laboratory based infectious disease diagnostics and research, laboratory support services, GCLP training and implementation
  • • We offer a full profile of clinical pathology assays and other specialized tests
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    Additional expertise includes TB diagnostics, biomaterials storage, PBMC processing, logistics, sample management, quality assurance and training.

     

  • • CLS has excellent management and quality assurance plans.
  • • The group is familiar with and utilizes a variety of International external quality assessment schemes.
  • • CLS has provided laboratory support for over 900 clinical trials of varying size.
  • • CLS understands the needs of clinical investigators as well as the laboratory contribution required to support good clinical practice.
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    THE REPOSITORY

    Capacity

  • • CLS has bio-repository capacity in Johannesburg, Cape Town and Durban. Processing and storage facilities are available for conditions ranging from ambient, refrigerated (2-8°C), frozen (-80°C) and Liquid Nitrogen (-196°C).
  • • The CLS repositories currently have a sample storage capacity of over 1 million specimens at -20°C to -196°C and 100 000 samples at vapor phase Liquid Nitrogen (LN2).
  • • The organization has experience to store in storing a variety of specimens that include: Whole Blood, Serum, Plasma, Cells, Body Fluids, Live cultures, Dried Blood Spots, Slides, Cytology and Histology specimens.
  • • CLS has had vast experience in the shipment of large number.
  • • All storage samples are tracked using an electronic bar-code tracking system, LDMS,LIMS and Dicitrix LIMS.
  • • Management reports are available upon request in an electronic format and can be exported to LDMS, LIMS and third party databases.
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    Security

  • • The repository has 24 hour maintenance cover and on site security.
  • • Biometrics -figure print access control to repository.
  • • All freezers are linked to an SMS alarm system for quick response time to any temperature fluctuation.
  • • Back-up liquid nitrogen and CO2 tanks.
  • • On site back-up generator.
  • • Oxygen Monitors.
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    Shipping

  • • Expertise with the Application of Import/Export permits.
  • • All staff are IATA trained and certified.
  • • Ambient, refrigerated, Dry ice and liquid nitrogen (Dry Shipper) shipment capabilities.
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    TB Laboratory

  • • CLS has a Biosafety level III TB laboratory.
  • • The BSLIII facility is fully equipped with state of the art equipment to perform the assays mentioned and also has access to our LDMS repository. The current scope of testing includes: ZN and Auramine smear, MGIT culture and susceptibility testing, LJ culture, Molecular assays for Mycobacteria detection and drug susceptibility testing using GenProbe PCR, HAIN PCR testing and GeneXpert MTB real-time PCR and Roche Light Cycler.
  • • We also offer is the TB Quantiferon testing (Cellestis QuantiFERON TB Gold).
  • • CLS is also involved in a range of TB studies with the ACTG, TB Alliance, OTSUKA, various Pharmaceutical companies and conducts basic investigator driven research studies.
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