PMID- 20937190
OWN - NLM
STAT- MEDLINE
DCOM- 20110127
LR  - 20211020
IS  - 1815-7920 (Electronic)
IS  - 1027-3719 (Print)
IS  - 1027-3719 (Linking)
VI  - 14
IP  - 11
DP  - 2010 Nov
TI  - MODS accreditation process for regional reference laboratories in Peru: 
      validation by GenoType(R) MTBDRplus.
PG  - 1475-80
AB  - SETTING: Although considerable effort has been put into the development and 
      evaluation of new diagnostics for tuberculosis (TB) and multidrug-resistant TB 
      (MDR-TB), little attention has thus far been paid to the technical aspects of 
      initiating quality-assured routine service use. For implementation of the 
      microscopic-observation drug susceptibility (MODS) methodology in the Peruvian 
      reference laboratory network, a laboratory accreditation process was devised; 
      MODS results from an expert reference laboratory (Universidad Peruana Cayetano 
      Heredia [UPCH]) were used as the standard against which implementing laboratory 
      MODS results were judged to ensure that, prior to use for patient care, 
      implementing laboratories achieved the same high performance with MODS as 
      previously demonstrated in the research laboratory. OBJECTIVE: To evaluate the 
      validity of MODS-based accreditation and the concordance of MODS drug 
      susceptibility testing (DST) with molecular testing. DESIGN: Head-to-head 
      comparison of MODS DST results from implementing Peruvian regional reference 
      laboratories and the accrediting expert MODS laboratory (UPCH) with GenoType(R) 
      MTBDRplus DST. RESULTS: The concordance of phenotypic MODS rifampicin (RMP) DST 
      with GenoType MTBDRplus was respectively 97.4%, 97.9% and 97.1% for the two 
      implementing regional laboratories and UPCH, and respectively 94.7%, 95.7% and 
      94.6% for isoniazid (INH) DST. CONCLUSION: High and consistent levels of 
      MODS/MTBDRplus concordance for INH and RMP DST confirm the validity of the use of 
      rapid methods as reference standards for accreditation.
FAU - Coronel, J
AU  - Coronel J
AD  - Laboratorio de Investigacion de Enfermedades Infecciosas, Universidad Peruana 
      Cayetano Heredia, Lima, Peru.
FAU - Roper, M
AU  - Roper M
FAU - Mitchell, S
AU  - Mitchell S
FAU - Castillo, E
AU  - Castillo E
FAU - Gamarra, N
AU  - Gamarra N
FAU - Drobniewski, F
AU  - Drobniewski F
FAU - Luna, G
AU  - Luna G
FAU - Mendoza, A
AU  - Mendoza A
FAU - Moore, D A J
AU  - Moore DA
LA  - eng
GR  - Wellcome Trust/United Kingdom
GR  - 078067/Wellcome Trust/United Kingdom
GR  - 078067/Z/05/Z/WT_/Wellcome Trust/United Kingdom
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Validation Study
PL  - France
TA  - Int J Tuberc Lung Dis
JT  - The international journal of tuberculosis and lung disease : the official journal 
      of the International Union against Tuberculosis and Lung Disease
JID - 9706389
RN  - 0 (Antitubercular Agents)
RN  - V83O1VOZ8L (Isoniazid)
RN  - VJT6J7R4TR (Rifampin)
SB  - IM
MH  - Accreditation/*organization & administration
MH  - Antitubercular Agents/pharmacology
MH  - Bacteriological Techniques/methods/standards
MH  - Humans
MH  - Isoniazid/pharmacology
MH  - Laboratories/*standards
MH  - Microbial Sensitivity Tests/methods/standards
MH  - Mycobacterium/drug effects/isolation & purification
MH  - Peru
MH  - *Quality Assurance, Health Care
MH  - Reference Standards
MH  - Rifampin/pharmacology
MH  - Tuberculosis/diagnosis/drug therapy/microbiology
MH  - Tuberculosis, Multidrug-Resistant/diagnosis/drug therapy/microbiology
PMC - PMC3103710
MID - UKMS35481
OID - NLM: UKMS35481
EDAT- 2010/10/13 06:00
MHDA- 2011/01/29 06:00
PMCR- 2011/05/28
CRDT- 2010/10/13 06:00
PHST- 2010/10/13 06:00 [entrez]
PHST- 2010/10/13 06:00 [pubmed]
PHST- 2011/01/29 06:00 [medline]
PHST- 2011/05/28 00:00 [pmc-release]
PST - ppublish
SO  - Int J Tuberc Lung Dis. 2010 Nov;14(11):1475-80.