A sample processing control spc and a probe check control pcc are also included in the cartridge utilized by the genexpert instrument. After a sample is loaded into a genexpert cartridge, the infinity 48 system does the rest sample in, answer out. The xpert xpress sarscov2 test includes reagents for the detection of rna from sarscov2 in nasopharyngeal, oropharyngeal, nasal, or midturbinate swab andor nasal washaspirate specimens. Xpert mrsasa blood culture xpert mrsasa blood culture assay. Contact cepheid customer service to order the assay specific cartridges. Because the cartridges are selfcontained, crosscontamination between specimens is minimized. Cepheid recognized as innovation leader sep 4, 2014. Copy and paste the link in windows explorer not internet explorer. Before mixing with cepheid sample reagent sr for decontamination, check that sample does not contain food particles. Infinity analyze user s manual microscope world the infinity software operates on 32 and 64bit platforms running windows 10 enterprise platform and standard, 8. Updated copies of the infinity analyze user s manual and the infinity capture user s manual are installed with the software.
For optimal user experience, please view this site in chrome, firefox, safari, or edge. The genexpert infinity systems are the latest advancement in molecular diagnostics total automation. Our largest genexpert system is configured with up to 80 modules meaning as many as 80 tests can operate independently at any given time with a capacity of about 2,000 tests per day. Put the dust cover when the system is not in use to limitate dust. Who prequalification of in vitro diagnostics public report. Some features of this site may not function properly.
Cepheid receives fda clearance and clia waiver for xpert. Cepheid and sherlock biosciences establish collaboration on. Cepheid genexpert dx systems and genexpert infinity systems nucleic acid purification system pcr thermocycler luminex 100200 or magpix instruments internal controls sample processing control spc and probe check control pcc integrated in assayinstrument system. In the genexpert operators manual, the user is instructed to contact cepheid technical support for information about calibration. For a full description of the systems, see the appropriate genexpert dx system operator manual or genexpert infinity system operator. With the capability of generating more than two thousand automated results per day, the genexpert infinity 80 is the most efficient, highest throughput molecular diagnostic system on the market delivered in the same footprint as our current.
Cepheid genexpert dx systems and genexpert infinity 48s and infinity 80 systems cepheid genexpert dx systems, genexpert infinity 48 system, and genexpert infinity 48s and infinity. The genexpert infinity systems enable a comprehensive menu of tests to be run on a single system, by a single operator, in a moderately complex, realtime environment. Genexpert dx system or genexpert infinity systems catalog number varies by configuration. The test is designed for use on any of cepheid s more than 25,000 genexpert systems placed worldwide, with results expected in as little as 35 minutes. Put instrument into manual mode and exit the xpertise software infinity 80 and 48s. Cepheid, the cepheid logo, genexpert and xpert are trademarks of cepheid. Calibration is performed by cepheid prior to installation. Genexpert infinity system brochure cepheid pdf catalogs. Even if cepheid cannot or does not repair or replace any defective instrument and pur. Jan 14, 2021 smaller genexpert systems are configured with 2 or 4 modules meaning up to four different tests can be run at one time.
C, june 2012 the end user license agreement is located at c. The epitome of platform consolidation, they enable a comprehensive menu of tests to be run on a single system, by a single operator, in a moderately complex, realtime environment. The genexpert cartridges are not supplied with the cepheid. We have 1 genexpert xpert mtb rif manual available for free pdf download.
Cepheid genexpert dx system operator manual walk the room. The test is being released as a european ce ivd mark product under the european directive on in vitro diagnostic medical devices. Page 11 iewing and rinting esults for detailed instructions on how to view and print the results, see the cepheid genexpert dx system operator manual or the genexpert infinity system operator manual, depending on the model that is being used. For detailed instructions, see the genexpert dx system operator manual. Xpert hiv1 viral load with genexpert dx, genexpert infinity 48, genexpert infinity 48s and genexpert infinity 80 1 manufactured by cepheid ab, ce marked regulatory version, was accepted for the who list of prequalified in vitro diagnostics and. Cepheid receives fda clearance for genexpert infinity80.
Xpert hcv viral load with genexpert dx, genexpert infinity 48s, and genexpert infinity 80 manufactured by cepheid ab, ce marked, was accepted for the who list of prequalified in vitro diagnostics and was listed on 04 april 2017. Cepheid is the exclusive owner of the cepheid genexpert dx system software program the software, related docu mentation and physical. Genexpert dx system or genexpert infinity systems catalog number. Viral transport media is available from several commercial vendors who may use the terminology vtm viral transport medium. Improving patient outcomes is the primary goal of any diagnostic system. Who emergency use assessment and listing for ebola virus ivds. Special 510k substantial equivalence determination decision. Cphd is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easytouse molecular systems and tests.
Jul 29, 2008 the newest addition to cepheid s genexpert family of molecular diagnostic testing systems delivers the worlds first and only fullyautomated random access system designed for management of the entire molecular testing workflow. With two sizes to choose from, cepheids unique cartridge technology, and exclusive load and go capability, the genexpert infinity provides maximum flexibility. Alternate transport media, not identified in the package inserts 3024421 xpert xpress sarscov2 flu rsv eua english package insert, 3025159 xpert xpress sarscov2 flu rsv ce ivd english package insert, should not be used with xpert xpress sarscov2flursv. Assay includes reagents for the detection of high risk hpv. Cepheid genexpert dx system operator manual worth avenue. If you need priority delivery on this item, please remove the item from the cart and call 8004724346 to speak with a sales representative who can assist in having this item expedited from the. Pqdx 025907000 xpert hiv1 qual assay with genexpert dx, genexpert infinity 48s, and genexpert infinity 80 infinity 80 manufactured by cepheid ab, ce marked regulatory version, was accepted for the who list of prequalified in vitro diagnostics and was listed on june 2016. The united states postal service biohazard detection system has run over ten million genexpert tests without a single false positive. Genexpert dx system or genexpert infinity systems varies by configuration genexpert instrument, computer with proprietary genexpert software version 4.
System operator manual or the genexpert infinity system operator manual. Feb 28, 2020 about cepheid based in sunnyvale, calif. All systems can be easily upgraded with additional modules. The genexpert diagnostic system is calibrated with fam, alexa fluor532, texas red, and alexa fluor647. A calibration check is recommended on the annual basis. Exit the xpress andor genexpert dx software infinity 48. Since 2006, cepheid has placed almost 7,100 genexpert and infinity systems in more than 120 countries globally, including more than 3,000 systems placed in the emerging markets in just the last three years. Genexpert systems the genexpert system is available in a one, two, four, 16, 48, or 80module configuration. The xpert hpv assay is designed for use with cervical specimens collected in preservcyt with either a. Genexpert dx system operator manual or the genexpert infinity system operator manual.
Instrument, cepheid will remove the instrument and return the purchase price for the defective instrument. But our genexpert family of systems have set a new standard in workflow flexibility, 247 testing accuracy, and user friendly design delivered in an astonishingly beautiful and compact package. Cepheid receives health canada license for sarscov2, flu a. It is imperative that all users read the genexpert operator. In addition, our cliawaived genexpert xpress is available for front line access and control, anywhere you need it. The xpert xpress sarscov2 test includes reagents for the detection of rna from sarscov2 in nasopharyngeal swab specimens. May 24, 2012 the genexpert infinity 80 has been initially cleared in conjunction with cepheid s xpert flu test. Sep 04, 2014 for example, our xpert mtbrif test is revolutionizing the management of tuberculosis worldwide. A 16site system can be configured with 4, 8, 12, or 16 modules. The genexpert system is available in a one, two, four, or 16module configuration. User manual genexpert xpert mtb rif user manual 25 pages semiquantitative nested realtime pcr invitro diagnostic test. For a full description of the system, see the genexpert dx system operator manual or the genexpert infinity system operator manual.
Jun 09, 2020 the xpert xpress sarscov2flursv fourinone test is expected to deliver qualitative detection of sarscov2, flu a, flu b and rsv from a single patient sample. By automating highly complex and timeconsuming manual procedures, the companys solutions deliver. Cepheid announces release of updated xpert bcrabl monitor. Cepheid genexpert user manual pdf how the test worksedit the xpert mtbrif detects dna sequences specific for mycobacterium tuberculosis and rifampicin resistance by polymerase chain reaction it is based on the cepheid genexpert system, a rapid, simpletouse nucleic acid amplification tests naat. Genexpert infinity genexpert xpress genexpert omni. Xpert hcv viral load, performed on genexpert instrument systems is designed for. The user does not calibrate or perform any serviceable functions on the instruments.
This warranty extends to purchaser only, and not to purchasers customers or other third parties, except as agreed to in writing by cepheid. Genexpert infinity 4824 molecular analyzer ea 1250573 cepheid gx inf 4824 please note this item may ship standard ground delivery service. For optimal user experience, please view this site in chrome. May 02, 2016 iv genexpert dx system operator manual 3010045 rev. By automating highly complex and timeconsuming manual procedures, the companys solutions deliver a better way for. Cphd today announced the release of an updated xpert bcrabl monitor test, now reporting results to the international scale. Cepheid technical support team may ask you to perform specific. Jul 25, 2012 about cepheid based in sunnyvale, calif.
Genexpert xpert mtb rif user manual pdf download manualslib. Cepheids genexpert infinity systems enable a comprehensive menu of tests to be run on a single system, by a single operator, in a moderately complex. Cepheid announces development of fourinone combination test. For more information on maintenance of genexpert genexpert user manual. Our genexpert family of systems have set a new standard in workflow flexibility, 247 testing accuracy, and user friendly design delivered in an astonishingly beautiful and compact package. The epitome of platform consolidation, they enable a comprehensive menu of tests to be run on a single system, by a single operator, in a moderately complex. Xpert check is performed every year to certify that the system remains within specification. For the highest throughput applications, a genexpert infinity system can scale to 80 modules. Xpert carbar rx only us ivd english package insert 3012438.
1225 1429 527 314 100 639 1372 1322 417 1091 967 1424 119 399 69 1368 989 1483 1586 594 862 544 1415 125 792 648 1532 549 1121 141 664 185 809 881