Appendix - Roche
Sep 14, 2020 · Source: Roche/Genentech; Zelboraf in collaboration with Plexxikon, a member of Daiichi Sankyo Group ~2 3k (thousands) 7 8 5 1 1 2 10 3 2 4 1 1 0 2 4 6 8 10 12 14 16 18 20 Stages IIc and III (resectable+unresectable) Drug-treated early stage melanoma IIc-III (resectable) BRAF mutation positive, drug-treated stages IIc and III (resectable) 2020
User Guide Publication Version 9 - Roche Diagnostics USA
the theory of liability, even if roche or any of its affiliates had been advised of the possibility of such damages roche’s total liability for all damages arising out of or relating to the use of the software by customer shall be limited, at roche’s option, to replacement of the software or a refund by roche of any license fees received from
Together against COVID-19 - rochecanadacom
Roche developed the CovidOptions ca page to make it easier to understand antibody testing June Roche contributes to Medtech Canada’s COVID-19 Action Hub on the impact of medical technology on the pandemic Some stories involving Roche are presented there: • The value of NAVIFY Tumor Board, a clinical assessment software to support
LightCycler® 480 Instrument Operators Manual
Roche Applied Science Customer Support Nonnenwald 2 82372 Penzberg, Germany Every effort has been made to ensure that all the information contained in the LightCycler® 480 Instrument Operator’s Manual is correct at the time of printing However, Roche Diagnostics GmbH reserves the right to make any changes necessary
CoaguChek® Patient Services Enrollment Guide
to Roche Health Solutions Inc that are not covered by Medicare, Medicaid or other insurance, including applicable co-payments and deductibles for which I am responsible I understand that if Roche Health Solutions Inc is out of network with my insurance, I have the option to get my care at either an in-network or an out of network provider
Test Name: SARS -CoV 2 Antibodies
Performance data supplied by Roche in the package insert for sensitivity and specificity: • Sensitivity 100 in patients >=14 days post-PCR confirmation • Specificity 99 8 including no cross-reactivity in patient cohorts tested against other seasonal coronaviruses confirmed via PCR
FastStart Universal SYBR Green Master (Rox)
4 lifescience roche com 1 General Information y Version: 06 FastStart Universal SYBR Green Master (Rox) 1 4 Application The FastStart Universal SYBR Green Master (ROX) is a ready-to-use, 2x concentrated master mix that contains all the reagents (except primers and template) needed for running real-time DNA detection assays, including qPCR and
Roche Applied Science Technical Note
Roche Applied Science Technical Note No LC 19/2004 Basic Information about Color Compensation 2 Generating Color Compensation 4-6 Color Compensation for Dual Color Applications that Use LightCycler Red 640 and LightCycler Red 705 Creating Color Compensation Files with SW 3 5 Creating Color Compensation Objects with SW 4 0
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May 11, 2020
New Test Announcement
Sunrise Medical Laboratories is offering a new antibody serology for SARS-CoV-2, the causative agent of COVID-19. The Roche Elecsys Anti-SARS-CoV-2 assay uses a recombinant protein representing the nucleocapsid (N) antigen for the determination of antibodies against SARS-CoV-2, including IgG. The assay method is Electrochemiluminescence Immunoassay (ECLIA), whereby coated microparticles are magnetically captured onto the surface of an electrode. Results are determined by comparing the electrochemiluminescence signal from the sample with the signal of the cutoff calibration. Performance data supplied by Roche in the package insert for sensitivity and specificity: Sensitivity 100% in patients >=14 days post-PCR confirmation. Specificity 99.8% including no cross-reactivity in patient cohorts tested against other seasonal coronaviruses confirmed via PCR. The Elecsys Anti-SARS-CoV-2 assay is only for use under the Food and Drug Authorization (EUA) under Section 564(d)(1) of the Act,21 U.S.C section 360bb-3(b)(1) unless authorization or terminated or revoked sooner.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate and high complexity tests.Test Information:
Test Code: 26506
Test Name: SARS-CoV-2 Antibodies
Ordering Recommendations:
Intended for the qualitative detection of antibodies to SARS-CoV-2 in human serum. The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Elecsys Anti-SARS-CoV-2 assay should not be used to diagnose acute SARS-CoV-2 infection. The individual immune response following SARS-CoV-2 infection varies considerably and may give different results with assays from different manufacturers. Fact sheet for Healthcare Providers: https://www.fda.gov/media/137603/download Fact sheet for Patients: https://www.fda.gov/media/137604/downloadSpecimen Requirements:
Sample Type:
1.0 ML Serum
Container Type: *Prefer dedicated collection deviceSerum Separator tube (SST®) preferred
Handling Instructions:
from cells ASAP or within 2 hours of collection.Transport: Refrigerated
Unsuitable Specimens: Heat-inactivated specimens. Specimens grossly hemolyzed. Specimens with obvious microbial contamination. Specimens with fungal growth.Testing Details:
Schedule: Sunday to Saturday
TAT: 48 hours
Stability: 3 days room temperature, 7 days refrigerated, 28 days frozenCPT Code: 86769
LOINC Codes: 94762-2
250 Miller Place Hicksville, NY 11801 1-800-782-0282 www.SUNRISELAB.com
Sunrise Medical Laboratories
Notification Date: 05/08/2020
New Test Offering Effective Date: 05/11/2020SARS-CoV-2 Antibodies
Order Code: 26506
Summary of changes: NEW test offering.
Specimen Requirements: 1.0 ML Serum collected from Serum Separator tube (SST®) (Min:0.5 ML minimum does not allow for repeat testing).Prefer dedicated collection device.
Transport Temperature: Refrigerated
Result Fields: LOINC
26562: SARS-CoV-2 Abs Interp.
26563: SARS-CoV-2 Abs Index 94762-2
Methodology: Electrochemiluminescence Immunoassay (ECLIA)Reference Range:
SARS-CoV-2 Abs Interp. Negative
SARS-CoV-2 Abs Index: <1.0
CPT: 86769
Additional Notes: Collection Instructions:
Centrifuge sample and separate from cells ASAP or within 2 hours of collection. Rejection Criteria: Heat-inactivated specimens. Specimens grossly hemolyzed. Specimens with obvious microbial contamination. Specimens with fungal growth. Stability: 3 days room temperature; 7 days refrigerated; 28 days frozenFrequency/Turn Around Sunday Saturday/ 48 hours
TimeTesting Location: Sunrise Medical Laboratories
250 Miller Pl., Hicksville, NY 11801
Test NameIn RangeOut RangeReference RangeTest NameIn RangeOut RangeReference RangeSpecimen Information
Specimen:B2305817
E Order:
Collected:05/07/2020 12:00
Received:05/07/2020 15:16
Reported:05/07/2020 15:27
Printed:05/07/2020 15:29
Patient Information
BE, BEE
DOB:03/23/1973
Age:47
Gender:F
Fasting:No
ID:Phone:
Ordering Physician
.TEST, DOCTORClient Information
JOHN DOE,MD9687
123 MAIN ST
ANYWHERE,
(631) 435-1515 Specimen InformationSpecimen:B2305817
E Order:
Collected:05/07/2020 12:00
Received:05/07/2020 15:16
Reported:05/07/2020 15:27
Printed:05/07/2020 15:29
Patient Information
BE, BEE
DOB:03/23/1973
Age:47
Gender:F
Fasting:No
ID:Phone:Ordering Physician
.TEST, DOCTORClient Information
JOHN DOE,MD9687
123 MAIN ST
ANYWHERE,
(631) 435-1515Sunrise Medical Laboratories
250 Miller Place - Hicksville, NY 11801
Client Service 800-782-0282
Report Status: Final
SARS-CoV-2 ANTIBODIES
SARS-CoV-2 Abs Interp.NegativeNegative
SARS-CoV-2 Abs Index0.4<1.0 COI
INTERPRETATIVE INFORMATION
Index (COI) Value Interpretation
< 1.0 Negative for anti-SARS-CoV-2 antibodies > or = 1.0 Positive for anti-SARS-CoV-2 antibodies This test is intended for the qualitative detection of antibodies to SARS-CoV-2 in human serum and as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and to what degree the presence of antibodies confers protective immunity. The Roche Elecsys Anti-SARS-CoV-2 assay should not be used to diagnose acute SARS-CoV-2 infection. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct PCR testing is recommended. False positive results may occur due to cross reactivity from pre-existing antibodies or other possible causes. This assay has overall sensitivity of 100% and specificity of 99.8% in patients >=14 days post-PCR confirmation. The Elecsys Anti-SARS-CoV-2 assay is only for use under the Food andDrug Administration's Emergency Use Authorization (EUA) under section564(d)(1) of the Act, 21 U.S.C section 360bb-3(b)(1) unless
authorization is terminated or revoked sooner. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate and high complexity tests.