Search Results

Alinity m EBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Epstein-Barr Virus (EBV) DNA in human EDTA plasma on the automated Alinity m System. Alinity m EBV is intended for use as an aid in the management of EBV in transplant patients undergoing monitoring of EBV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. The results from Alinity m EBV must be interpreted within the context of all relevant clinical and laboratory findings. Alinity m EBV is not cleared for use as a screening test for donors of blood products, or human cells, tissues, and cellular and tissue-based products (HCT/Ps) for EBV.

Alinity m EBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of EBV DNA in human plasma. The steps of the Alinity m EBV assay consist of sample preparation, real-time PCR assembly, amplification/detection, result calculation, and reporting. All stages of the Alinity m EBV procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m EBV assay in parallel with other Alinity m assays on the same instrument. Alinity m EBV requires three separate assay specific kits as follows: - . Alinity m EBV AMP Kit (List No. 09N43-095) consisting of multi-well amplification trays (AMP Trays) containing lyophilized, unit-dose PCR amplification/detection reagents and multi-well activation trays (ACT Trays) containing liquid, unit-dose activation reagents (MgCl2, TMAC, KCl, and ProClin). The intended storage condition for the Alinity m EBV AMP Kit is 2°C to 8°C. - Alinity m EBV CTRL Kit (List No. 09N43-085) consisting of a negative control, a low positive control, and a high positive control, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m EBV CTRL Kit is —15°C to —25°C. - . Alinity m EBV CAL Kit (List No. 09N43-075) consisting of two levels of calibrators (CAL A and CAL B), each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m EBV CAL Kit is -15°C to -25°C. EBV DNA from specimens is extracted automatically on-board in the Alinity m System using the Alinity m Sample Prep Kit 2, Alinity m Lysis Solution, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash and elution. The resulting purified nucleic acids are then combined with the liquid unit-dose Alinity m EBV activation reagent and lyophilized unit-dose Alinity m EBV amplification/detection reagents and transferred into a reaction vessel. Alinity m Vapor Barrier Solution is then added to the reaction vessel which is then transferred to an amplification/detection unit for PCR amplification and real-time fluorescence detection of EBV targets. An EBV calibration curve is required for the quantitation of EBV targets. Two levels of calibrators are processed through sample preparation and real-time PCR to generate the calibration curve. The concentration of EBV DNA in specimens and controls is then calculated from the stored calibration curve. Assay controls are tested at or above an established minimum frequency to help ensure that instrument and reagent performance remain satisfactory. During each control event, a negative control, a low-positive control, and a high-positive control are processed through sample preparation and real-time PCR procedures that are identical to those used for specimens. At the beginning of the Alinity m EBV sample preparation process, a lyophilized unit -dose of Internal Control on the AMP Tray is rehydrated by the Alinity m System and delivered into each sample preparation reaction. The Internal Control is then processed through the entire sample preparation and real-time PCR procedure along with the specimens, calibrators and controls to demonstrate proper sample processing and assay validity. The Alinity m EBV amplification and detection reagents include primers and probes that amplify and detect dual targets in the EBV genome. Amplification and detection of the two EBV targets ensures sensitive detection of the viral genome even at low levels. The Alinity m EBV assay also utilizes the following accessories: - . Alinity m EBV Application Specification File, List No. 09N43-05A - . Alinity m System and System Software, List No. 08N53-002 - . Alinity m Sample Prep Kit 2, List No. 09N12-001 - . Alinity m Specimen Dilution Kit I, List No. 09N50-001 - . Alinity m Tubes and Caps, List No. 09N49: - . Alinity m LRV Tube, List No. 09N49-001 - Alinity m Transport Tubes Pierceable Capped, List No. 09N49-010 ● - Alinity m Transport Tube, List No. 09N49-011 . - . Alinity m Pierceable Cap, List No. 09N49-012 - . Alinity m Aliquot Tube, List No. 09N49-013 - . Alinity m System Solutions, List No. 09N20: - . Alinity m Lysis Solution, List No. 09N20-001 - Alinity m Diluent Solution, List No. 09N20-003 . - . Alinity m Vapor Barrier Solution, List No. 09N20-004

The Alinity m STI Assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from Chlamydia trachomatis (CT), DNA from Neisseria gonorrhoeae (NG), ribosomal RNA from Trichomonas vaginalis (TV), and ribosomal RNA from Mycoplasma genitalium (MG), to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following specimens from symptomatic and asymptomatic individuals for the following analytes: CT: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, male urine, oropharyngeal swabs, and rectal swabs NG: vaginal swabs (clinician-collected and self-collected in a clinical setting). endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, male urine, oropharyngeal swabs, and rectal swabs TV: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, female urine, and male urine MG: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, and male urine A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher clinical sensitivity compared to endocervical swabs. If endocervical swab specimens test negative, testing with a vaginal swab may be indicated if M. genitalium infection is suspected.

The Alinity m STI Assay is a real time polymerase chain reaction (PCR) assay for the amplification and detection of Chlamydia trachomatis (CT) ribosomal RNA sequences, Neisseria gonorrhea (NG) genomic DNA sequences, Trichomonas vaginalis (TV) ribosomal RNA sequences, Mycoplasma genitalium (MG) ribosomal RNA sequences, and human genomic DNA sequences. The assay can be used with endocervical swab specimens, vaginal swab specimens, male and female urine specimens, gynecological specimens in ThinPrep® PreservCyt® Solution, oropharyngeal swab specimens, and rectal swab specimens. Endocervical swab, vaginal swab, oropharyngeal swab, rectal swab and urine specimens are collected with the Alinity m multi-Collect Specimen Collection Kit. PreservCyt Solution specimens are transferred to an Alinity m Transport Tube for processing on the Alinity m System. The steps of the Alinity m STI Assay consist of sample preparation, RT-PCR assembly, amplification/detection, and result calculation and reporting. All stages of the Alinity m STI Assay procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m STI Assay in parallel with other Alinity m assays on the same instrument. The Alinity m STI Assay requires two separate assay specific kits as follows: - . Alinity m STI AMP Kit, List No. 09N17-095 consisting of multi-well amplification plates containing lyophilized, unit-dose PCR amplification/detection reagents and multi-well activator plates containing liquid, unit-dose activation reagents (MgCl2, TMAC, and KCl). The intended storage condition for the Alinity m STI AMP Kit is 2℃ to 8℃. - . Alinity m STI CTRL Kit, List No. 09N17-085 consisting of negative controls and positive controls, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m STI Control Kit is -15°C to -25°C. Nucleic acids from specimens are extracted automatically on-board the Alinity m System using the Alinity m Sample Prep Kit 1, Alinity m Lysis Solution, Alinity m Ethanol Solution, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash and elution. The resulting purified nucleic acids are then combined with the liquid unit-dose activator reagent, lyophilized unit-dose Alinity m STI amplification reagents, and Alinity m Vapor Barrier Solution, and transferred by the instrument to an amplification/detection module for reverse transcription, PCR amplification, and real-time fluorescence detection. Assay controls are tested at or above an established minimum frequency of every 24 hours to help ensure that instrument and reagent performance remain satisfactory. During each control event, a negative control and a positive control are processed through sample preparation and RT-PCR procedures that are identical to those used for specimens. Assay controls are used to demonstrate proper sample processing and assay validity. The controls do not indicate if bacterial cells have been adequately lysed. The Alinity m STI amplification reagents include primers and a probe that amplify and detect the single copy human gene, ß-globin. Amplification and detection of the ß-globin gene demonstrates proper sample processing and adequate sample input. In addition, an exogenous internal control (containing an armored RNA sequence) is included in the lyophilized Alinity m STI amplification reagents to assess amplification efficiency and to confirm that no PCR inhibitors are present in the sample. The cellular control and internal control are both used to demonstrate assay validity. The Alinity m STI Assay also utilizes the following accessories: - . Alinity m STI Assay Application Specification File, List No. 09N17-03A - . Alinity m System and System Software, List No. 08N53-002 - Alinity m Sample Prep Kit 1, List No. 09N18-001 . - Alinity m multi-Collect Specimen Collection Kit, List No. 09N19-010 . - . Alinity m Tubes and Caps, List No. 09N49: - Alinity m Transport Tubes Pierceable Capped, List No. 09N49-010 . - . Alinity m Transport Tube, List No. 09N49-011 - Alinity m Pierceable Cap, List No. 09N49-012 . - Alinity m System Solutions, List No. 09N20: . - Alinity m Lysis Solution, List No. 09N20-001 . - Alinity m Ethanol Solution, List No. 09N20-002 . - Alinity m Diluent Solution, List No. 09N20-003 - Alinity m Vapor Barrier Solution, List No. 09N20-004 •

The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorthoeae. The assay may be used to test the following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected vaginal swab and patient-collected vaginal swab specimens; female and male urine specimens. The Abbott multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female swab and urine specimens for the detection of Chlamydia trachomatis and Neisseria gonorrheae per instructions provided. Refer to the specimen collection procedure in the package insert for specimen collection instructions for specific sample types. Self-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Abbott multi-Collect Specimen Collection Kit is not intended for home use.

The Abbott multi-Collect Specimen Collection Kit can be used to collect either a swab or a urine specimen. Each Abbott multi -Collect Specimen Collection Kit contains: - . One capped Transport Tube containing 1.2 mL Specimen Transport Buffer - . One Individually Packaged Sterile Specimen Collection Swab - . One disposable transfer pipette. The Specimen Transport Buffer is used to stabilize DNA until sample preparation. The individually packaged sterile Specimen Collection Swab is used for swab sample collection and placed directly into the Transport Tube. The transfer pipette is used to add approximately 3 mL of urine to the Transport Tube. The Abbott multi -Collect Specimen Collection Kit is for single use only. The Abbott multi-Collect Specimen Collection Kit Swab is approximately 14 cm in length with a polyester fiber tip. The swab shaft has a polystyrene solid core that is orange in color. The swab has a molded score completely around the shaft, between 7.86 cm and 7.89 cm from the swab tip, to provide a clean break-point. The polyesterfiber swab tip is approximately 1.3 cm in length and less than 3.28 mm in diameter.

The Vysis D7S486/CEP 7 FISH Probe Kit is a device intended for specimen characterization, and detects the LSI D7S486 probe target on chromosome 7q31 and the CEP 7 probe target on chromosome 7p11.1-q11.1 in bone marrow and peripheral blood specimens from patients with acute myeloid leukemia or myelodysplastic syndrome. The assay results are intended to be interpreted by a qualified pathologist or cytogeneticist. This device is not intended for high-risk uses such as selecting therapy, predicting therapeutic response or disease screening. The use of this device for diagnosis, prognosis, monitoring or risk assessment has not been established.

The Vysis D7S486/CEP 7 FISH Probe Kit is for specimen characterization and detects the LSI D7S486 (7q31) probe target on chromosome 7q31 and CEP 7 probe target chromosome 7p11.1-q11.1 in bone marrow and peripheral blood specimens. DNA Probe Description Vysis LSI D7S486 SpectrumOrange/ CEP 7 SpectrumGreen Probes: The SpectrumOrange labeled LSI D7S486 probe is approximately 308 kb in length (chr7:115983468-115675366; February 2009 Assembly UCSC Human Genome Browser). The SpectrumGreen labeled CEP 7 probe targets the D7Z1 alpha satellite sequence at the centromere of chromosome 7. The Vysis D7S486/CEP 7 FISH Probe Kit (List No. 04N78-020) consists of a mixture of two DNA FISH probes and four general reagents sufficient to process 20 assays. - . Vysis LSI D7S486 SpectrumOrange/ CEP 7 SpectrumGreen Probes - . Vysis LSI/WCP Hybridization Buffer - . DAPI II Counterstain - NP-40 . - . 20X SSC

The Vysis EGR1 FISH Probe Kit - SC detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. The Vysis EGR1 FISH Probe Kit -SC assay results characterize bone marrow specimens from patients with acute myeloid leukemia or myelodysplastic syndrome. The assay results are intended to be interpreted by a qualified pathologist or cytogeneticist. This device is not intended for high-risk uses such as selecting therapy, predicting therapeutic response or disease screening. The use of this product for diagnosis, monitoring or risk assessment has not been established.

The Vysis EGR1 FISH Probe Kit - Specimen Characterization uses fluorescence in situ hybridization (FISH) DNA probe technology to detect probe target LSI EGR1 (containing early growth response 1 gene; location chromosome 5g31). The LSI D5S23, D5S721 probe (location chromosome 5p15.2) serves as a control. The Vysis EGR1 FISH Probe Kit – SC (List No. 04N37-001) consists of the following components which are sufficient to process 20 assays: 1. Vysis LSI EGR1 SpectrumOrange/D5S23, D5S721 Spectrum Green Probes 2. Vysis LSI/WCP Hybridization Buffer 3. DAPI II Counterstain 4. NP-40 5. 20X SSC Salt Items 2 through 5 above are general purposes reagents. DNA Probes: Vysis LSI EGR1 SpectrumOrange/ D5S23, D5S721 SpectrumGreen. a. The SpectrumOrange-labeled LSI EGR1 probe, approximately 209 kb in length (chr5:137654208-137862738; February 2009 Assembly; UCSC Human Genome Browser) is located at 5g31 and contains the complete EGR1 gene. b. The SpectrumGreen-labeled LSI D5S23, D5S721 probe, approximately 561 kb in length (chr5:9397109-9958407; February 2009 Assembly; UCSC Human Genome Browser) is located at 5p15.2.

The Vysis EGR1 FISH Probe Kit is intended to detect deletion of the LSI EGR1 probe target on chromosome 5q in bone marrow specimens and to be used, in addition to cytogenetics, other biomarkers, morphology and other clinical information, at the time of acute myeloid leukemia (AML) diagnosis as an aid in determining prognosis. Deletion of chromosome 5q has been associated with an unfavorable prognosis in AML patients.

The Vysis EGR1 FISH Probe Kit uses fluorescence in situ hybridization (FISH) DNA probe technology to determine deletion status of the LSI EGR1 (containing early growth response 1 gene; location chromosome 5q31) probe target in AML specimens. The Vysis EGR1 FISH Probe Kit also contains the LSI D5S23, D5S721 probe (location chromosome 5p15.2) and serves as a control. The kit consists of one vial containing two DNA FISH probes and four general purpose reagents sufficient to process 20 specimens.

The Vysis CLL FISH Probe Kit is intended to detect deletion of the LS1 TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL). The assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group versus the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology, and other clinical information. The Vysis CLL FISH Probe Kit is not intended for use in selection of therapy or in monitoring of residual disease.

The Vysis CLL FISH Probe Kit uses fluorescence in situ hybridization (FISH) DNA probe technology to determine deletions of the locus-specific identifier (LSI) TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence. The Vysis CLL FISH Probe Kit (List No. 4N02-020) consists of two DNA FISH probe sets and three general purpose reagents sufficient to process 20 assays. - . LSI TP53 SpectrumOrange/ATM SpectrumGreen Probe - LSI D13S319 SpectrumOrange/13q34 SpectrumAqua/CEP 12 SpectrumGreen Probe . - DAPI II Counterstain . - NP-40 . - 20X SSC Salt .

The Abbott RealTime CT/NG (List No. 8L07-91) assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected vaginal swab and patient-collected vaginal swab specimens; female and male urine specimens.

Abbott RealTime CT/NG consists of two reagent kits: - · Abbott RealTime CT/NG Amplification Reagent Kit (List No. 8L07-91) - · Abbott RealTime CT/NG Control Kit (List No. 8L07-80) The Abbott RealTime CT/NG assay uses PCR technology with homogenous real-time fluorescence detection on the m2000 System. The Abbott m2000 System consists of the Abbott m2000sp and Abbott m2000rt instruments. The Abbott m2000 System integrates sample preparation with nucleic acid amplification and detection to generate assay results. The Abbott m2000sp is used for processing samples and the Abbott m2000rt is used for amplification and detection.

The Abbott m2000 system is intended for in vitro diagnostic use in performing FDA cleared and approved nucleic acid testing in clinical laboratories. It comprises the Abbott m2000sp and the Abbott m2000rt instruments. The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing. The Abbott m2000rt is an automated system for performing fluorescence-based PCR to provide quantitative and qualitative detection of nucleic acid sequences.

The Abbott m2000 System is an instrument platform that automates steps to perform nucleic acid amplification assays from sample processing through amplification, detection, and data reduction. The Abbott m2000 System comprises the m2000sp and m2000rt instruments, which are operated with separate System Control Center (SCC) workstations. Each instrument contains an independent software application; one for the m2000sp and a second for the m2000rt. The m2000sp instrument is a floor standing, automated sample preparation system. The three main components of the m2000sp are the: Instrument, Cabinet, System Control Center (SCC). The m2000rt instrument is a real-time PCR thermal cycler/reader instrument system. The two main components of the m2000rt are the: Instrument, System Control Center (SCC). The Abbott m2000 System software processes sample preparation and amplification/detection protocols based on pre-determined, assay-specific parameters that are contained in individual assay application specification files that are installed on the SCC. The Abbott m2000sp reads and processes bar coded primary sample tubes and processes up to 96 specimens, controls, and calibrators in batch mode. The m2000 System is capable of processing samples from various matrices, depending on the specific assay application, including plasma, serum, endocervical swabs, urethral swabs, vaginal swabs, and urine. At the completion of the automated sample preparation protocol, the operator seals and manually transfers the PCR plate to the Abbott m2000rt for nucleic acid detection. Bar code and m2000sp data is transferred to the m2000rt electronically.

The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected vaginal swab and male urethral swab specimens; patient-collected vaginal swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: male and female urine. The Abbott multi-Collect Specimen Collection Kit is intended for the collection and transportation of malc and female swab and urine specimens for the detection of Chlamydia trachomatis and Neisseria gonorrheae per instructions provided. Self-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Abbott multi-Collect Specimen Collection Kit is not intended for home use.

Abbott RealTime CT/NG consists of two reagent kits: - . Abbott RealTime CT/NG Amplification Reagent Kit (List No. 8L07-90) - Abbott RealTime CT/NG Control Kit (List No. 8L07-80) . The Abbott RealTime CT/NG assay uses PCR technology with homogenous real-time fluorescence detection on the m2000 System. The Abbott m2000 System consists of the Abbott m2000sp and Abbott m2000rt instruments. The Abbott m2000 System integrates sample preparation with nucleic acid amplification and detection to generate assay rcsults. The Abbott m2000sp is used for processing samples and the Abbott m2000rt is used for amplification and detection. The Abbott multi-Collect Specimen Collection Kit can be used to collect either a swab or a urine specimen. Each Abbott multi -Collect Specimen Collection Kit (List No. 9K12) contains: - One Transport Tube containing 1.2 mL Specimen Transport Buffer . - . One Individually Packaged Sterile Specimen Collection Swab (Part No. CD650) - . One disposable transfer pipette. The Specimen Transport Buffer consists of guanidine thiocyanate, a chaotropic salt, in Tris buffer and is used to stabilize DNA until sample preparation. The individually packaged sterile Specimen Collection Swab is used for swab sample collection and placed directly into the Transport Tube. The transfer pipette is used to add approximately 3 mL of urine to the Transport Tube. The Abbott multi -Collect Specimen Collection Kit is for single use only.