The lack of readily available, patient-derived materials for molecular genetic testing of many heterozygous or rare disorders creates a major impediment for laboratory proficiency and quality control procedures.
The method of viral load quantification used in the study has been certified by the Virology Quality Assurance at Rush University, Chicago, IL, as a part of the laboratory proficiency testing.
Once the laboratory achieved pre-determined minimum standard efficiency levels based on WHO/IUATLD Supranational Reference Laboratory proficiency testing criteria for performance [29] of 80% (E and S), 89% (Inh), and 95% (Rif) in performing MGIT DST, MGIT and LJ culture and FLD DST were performed in parallel and all results were made available to clinicians.
Similar associations of CV and laboratory proficiency have been noted during the uterotrophic validation (Kanno et al. 2001, 2003).
The dynamic range and reliability of measurements on microarray assays can be further compromised by suboptimal laboratory proficiency with this technology.
Before study implementation, we tested 50 MTB isolates of known resistance patterns from WHO's External Quality Assurance program to evaluate laboratory proficiency in using this assay.
In addition, comparability of laboratory methods used in EPIC and EFCOVAL laboratories was further substantiated by evaluating standard reference materials and quality control procedures (e.g., inter-laboratory proficiency tests) of each laboratory measurement.
In a follow-up study, laboratory proficiency was assessed by distribution of unknown specimens for blinded testing to a subset of 29 facilities in Idaho and Utah (K.B. Stevenson et al., unpub. data).
The present study was undertaken with two aims in mind: first to evaluate a possible substitution of VACV with MVA and second to investigate the robustness of the test in evaluating the laboratory proficiency in a multi-center study.
Liquid culture systems can play a valuable role in TB case detection in laboratories in high burden settings, but laboratory workers, policy makers and clinicians should be aware of the increased risks, independent of laboratory proficiency, of cross-contamination events in high burden settings.
