Laboratory
HIV-NAT laboratory
The HIV-NAT Research Laboratory’s mission is to provide high quality service to our patients in a timely manner to assure accurate data as well as preserve the integrity and safety of all participants involved in our studies, including collaborative sites. The laboratory functions as a central laboratory for multi-centre studies and a large number of national and international pharmaceutical clinical trials. Even though the laboratory has the appropriate number of staff, equipments, specimen repository facilities and infrastructure, yet we continue to strengthen the capacities of all aspects of the laboratory services. As HIV is ever evoling, thus we want to be able to keep up with it so we are constantly updating our services. This year we are significantly moving forward with the lab. We have accomplished much this year. Our staff have been working very hard to ensure this and continue to provide exceptional customer services to HIV-NAT and our colleagues.
This year, as part of the AIDS Clinical Trials Group (ACTG) network, the laboratory had to do additional validations, certifications and changes to be up to par with the standards set by the network. The LDMS system for all laboratory test results, specifically for the ACTG network, has been officially implemented. The HIV-NAT laboratory has already received its external quality audit from the College of American Pathologists (CAP) and renewed its accreditation on March (LAP Number:7197506, AU-ID: 1475967) with satisfactory performance upon inspection. The laboratory has met all standards required by CAP.
During the year 2015, the HIV-NAT Research Laboratory continues to provide laboratory services for HIV-NAT, Chula Clinical laboratory (Chula CRL) and SEARCH. Unlike last year, the number of studies has increased two-folds so we had to expand our capacity to be able to fulfil the needs of our customers. The laboratory now can perform several additional laboratory assays that were never available in the past such as measuring the amount of hormones in the blood.
Aside from offering more assays, our HIV-NAT Pharmacokinetics laboratory has started setting up services to measure other antiretroviral drugs. For example, we now can therapeutically measure the drug levels for Dolutegravir. The reason for this is because many of our studies have shown that Thais tend to have higher drug levels despite using the standard doses which were established in Caucasians. In addition, working with Government Pharmaceutical Organization (GPO) of Thailand, we assess the quality, efficacy, stability and safety of the newly developed generic Ritonavir (RTV) tablet (GPO-RTV) which is in a solid form that does not require refrigeration. RTV is commonly used in Thailand and refrigeration is not always possible for all of the patients. Therefore, GPO has decided to develop tablets that do not need refrigeration. HIV-NAT has always provided GPO with recommendations for developing new generic drugs that will help improve drug administration and adherence. Thus, we have to do many quality assessments for these generic products to ensure its quality, efficacy, stability and safety before providing it freely through the national program. We also provide dissolution data so that these generics can be used abroad as well. As part of a humanitarian, research organization, we want to be able to help other countries within the region to also have access to good, quality drugs at a more affordable price. Together, we can end AIDS within the region as per our country’s vision and aim.
In addition, we serve as the central specimen repository for several studies such as the Flu002/003, IRC 003/004, START, etc. The specimen storages are kept in -70 freezer and liquid nitrogen dewars. HIV-NAT laboratory has extensive experience in handling specimen for both short-term and long-term storages. For non-HIV studies, we have expanded our services to provide short-term storages for the specimens.
Furthermore, we also process, store and ship research specimens, including peripheral blood mononuclear cells (PBMCs), to other sites or international, central laboratories. The HIV-NAT Laboratory continues to perform satisfactory as per the IQA Cryopreservation PT Program for Peripheral Blood Mononuclear Cells (PBMC), organized by the Duke University, USA. We have renewed our certificates for Annual Specimen Testing Volume 2014/15; Hematology/Chemistry/Serology 143,111; Virology 9075; CD4/CD8 9624 ; and Specimen storage 31992. Aside from that, we continue to maintain our quality assurance performance internally as well. We routinely and regularly perform internal audit and proficiency testings. All findings were minor problems and the corrective/preventive actions have been implemented in a timely manner as appropriate. The root cause of the problems was investigated thoroughly and managed accordingly. Overall proficiency testings for 2015 were satisfactory. Even though all standards of quality for the lab are satisfactory, the HIV-NAT Research laboratory will continue to find ways to improve its quality and services to ascertain how best it can serve the organization, country and the region. Additional quality system such as the Six Sigma is being considered to be implemented in the near future.
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