GeneXpert GXMTB RIF-10 User Manual Download | Manualshive

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GXMTB/RIF-10

GXMTB/RIF-10

301-0191 Rev. C, May 2012

In Vitro

Diagnostic Medical Device

Xpert MTB/RIF

R

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Summary of Contents for GXMTB RIF-10

Page 1: ...BCR ABL say GXMTB RIF 10 GXMTB RIF 10 301 0191 Rev C May 2012 In Vitro Diagnostic Medical Device Xpert MTB RIF R...

Page 2: ...ims of any non US counterpart s thereof This product is sold under license from the Public Health Research Institute and may be used under PHRI patent rights only for human in vitro diagnostics NO OTH...

Page 3: ...lion people are infected with MTB 1 Every year almost 9 million people develop active disease and 2 million people die of the illness Active MTB which is predominantly pulmonary in nature is a highly...

Page 4: ...ontamination between samples is eliminated For a full description of the system see the GeneXpert Dx System Operator Manual or GeneXpert Infinity System Operator Manual Xpert MTB RIF includes reagents...

Page 5: ...beads within this product was produced exclusively from bovine plasma sourced in the United States The manufacturing of the BSA is also performed in the United States No ruminant protein or other anim...

Page 6: ...the detection of MTB complex has not been demonstrated from non respiratory specimens such as blood CSF stool or urine The performance of the Xpert MTB RIF Assay has not been evaluated with specimens...

Page 7: ...MENTS PROCEDURE Note Reject specimens with obvious food particles or other solid particulates Volume Requirements Sputum sediments prepared according to the method of Kent and Kubica8 and re suspended...

Page 8: ...Xpert MTB RIF cartridge with the sample ID Note Write on the sides of the cartridge or affix an ID label Do not put the label on the lid of the cartridge or cover the existing 2D barcode on the cartri...

Page 9: ...idge 1 Open the cartridge lid and then open the sample container 2 Using the provided transfer pipette aspirate the liquefied sample to the line on the pipette Do not process the sample further if the...

Page 10: ...k the Software shortcut icon 2 Log on to the GeneXpert Dx System software using your user name and password 3 In the GeneXpert Dx System window click Create Test The Scan Sample ID dialog box appears...

Page 11: ...institution s standard practices 2 Do not burn used cartridges 3 Do not discard used cartridges in a landfill or dump H 6 VIEWING AND PRINTING RESULTS For detailed instructions on how to view and prin...

Page 12: ...tive or positive in a positive sample The SPC passes if it meets the validated acceptance criteria The test result will be Invalid if the SPC is not detected in a negative test PCC Before the start of...

Page 13: ...J Interpretation of Results 301 0191 Rev C May 2012 11 Figure 7 MTB DETECTED LOW Rif Resistance NOT DETECTED Privileged User View Figure 8 MTB NOT DETECTED Privileged User View...

Page 14: ...pass MTB DETECTED Rif Resistance INDETERMINATE The MTB target is present within the sample RIF resistance could not be determined due to insufficient signal detection SPC NA not applicable An SPC sig...

Page 15: ...in this insert is necessary to avoid erroneous results A positive test result does not necessarily indicate the presence of viable organisms It is however presumptive for the presence of MTB and RIF...

Page 16: ...t but were not tested by smear microscopy or culture these patients are not included in the data analyses presented in the tables L 3 MTB DETECTION RESULTS Overall when considering a composite of the...

Page 17: ...le the Xpert MTB RIF Assay sensitivity for RIF resistance detection was 97 2 141 145 in RIF resistant patients The specificity in RIF sensitive cases was 98 3 412 419 See Table 5 Table 4 Xpert MTB RIF...

Page 18: ...ert 3 100 76 76 95 2 100 99 0 95 96 94 3 99 8 98 8 160 162 95 6 99 7 99 1 331 334 97 4 99 8 Xpert 1 97 3 73 75 90 8 99 3 96 8 92 95 91 1 98 9 98 8 159 161 95 6 99 7 97 9 324 331 95 7 99 2 NAAT 100 76...

Page 19: ...lls spiked into negative clinical sputum samples Under the conditions of the study results indicate that the LoD point estimate for M tuberculosis is 131 CFU mL with a 95 confidence interval ranging f...

Page 20: ...emophilus influenzae Salmonella typhi Acinetobacter calcoaceticus Haemophilus parahemolyticus Serratia marcescens Actinomyces meyeri Haemophilus parainfluenzae Shigella boydii Bacillus cereus Klebsiel...

Page 21: ...MTB RIF correctly detected all MTB strains and correctly identified the RIF resistant isolates L 10 ANALYTICAL INACTIVATION OF MYCOBACTERIA IN SPUTUM SAMPLES The disinfection capability of the Xpert...

Page 22: ...gical and biomedical laboratories Richmond JY and McKinney RW eds 1993 HHS Publication number CDC 93 8395 7 Clinical and Laboratory Standards Institute formerly National Committee for Clinical Laborat...

Page 23: ...urope for assistance Cepheid Europe Vira Solelh 81470 Maurens Scopont France Telephone 33 563 82 53 00 Fax 33 563 82 53 01 www cepheidinternational com Region Telephone Email North America 1 888 838 3...

Page 24: ...OF SYMBOLS CEPHEID AB R ntgenv gen 5 SE 171 54 Solna Sweden Symbol Meaning European conformity Catalog number In vitro diagnostic medical device Batch code Do not reuse Caution consult accompanying do...

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