2007
DOI: 10.1373/clinchem.2007.085472
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Development of an Integrated Assay for Detection of BCR-ABL RNA

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Cited by 49 publications
(37 citation statements)
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“…14 The GeneXpert system showed high sensitivity (91.2%) and specificity (95%) as compared with the clinical ASR reference method, based on the simplified result reporting (positive, negative, or invalid) of the system software. The few false-negative samples either yielded no BCR-ABL signal (BCR-ABL Ct ϭ 0) or were interpreted as negative by the software due to the preset threshold (BCR-ABL Ct must be less than or equal to 32 14 ). Further studies may be needed to fine tune criteria for reporting results as negative.…”
Section: Discussionmentioning
confidence: 94%
“…14 The GeneXpert system showed high sensitivity (91.2%) and specificity (95%) as compared with the clinical ASR reference method, based on the simplified result reporting (positive, negative, or invalid) of the system software. The few false-negative samples either yielded no BCR-ABL signal (BCR-ABL Ct ϭ 0) or were interpreted as negative by the software due to the preset threshold (BCR-ABL Ct must be less than or equal to 32 14 ). Further studies may be needed to fine tune criteria for reporting results as negative.…”
Section: Discussionmentioning
confidence: 94%
“…It therefore preserves the stability and homogeneity of the calibrators, 2 important characteristics for an analytical reference material. In our study, the direct heat-lysis protocol was compatible with multiplex and singleplex methods, 1-and 2-step protocols, various real-time PCR instruments from multiple manufacturers, manual and automated setups, and commercial and laboratorydeveloped reagents (2, 22, 26 -29 ), but it could not be evaluated with integrated closed assay systems such as the GenXpert instrument (31 ).…”
Section: Synthetic Bcr-abl1 Calibrator Panels For Is Standardizationmentioning
confidence: 95%
“…185 It is likely that some of the intrinsic difficulties related to the complex time consuming methodology which requires specialized skills and knowledge may be overcome by the new automated BCR-ABL1 assay that is contained within a single-use microfluidic cartridge, using a specialized instrument, such as the Cepheid GeneXpert. 186 It is of interest that this specialized equipment was initially developed for bioterrorism assays following the anthrax attacks in the USA soon after the September 11 attacks in 2001. In this system, RNA extraction and real-time PCR is prepared.…”
Section: -177mentioning
confidence: 99%