Upload
others
View
3
Download
0
Embed Size (px)
Citation preview
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
Innovación en Fase Preanalítica
Dr. Raul Postigo
Clinical & Marketing Manager (Iberia)
BD Life Sciences – Preanalytical Systems
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
¿Dónde innovar?
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
El tiempo de respuesta (TAT) representa 3 de las 5
máximas prioridades para los laboratorios
TAT = 36,5%
¿Qué es lo más importante para el laboratorio?
Jones BA, et al. Physician satisfaction with clinical laboratory services: a College of American Pathologists Q-probes
study of 138 institutions. Arch Pathol Lab Med. 2009;133:38-43.
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
Sin embargo, el TAT se encuentra entre las áreas de mejora
Jones BA, et al. Hospital Nursing Satisfaction With Clinical Laboratory Services: A College of American Pathologists Q-
Probes Study of 162 Institutions. Arch Pathol Lab Med 2006;130:1756-61.
¿Cual es el nivel de satisfacción actual? Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
¿Como reducir el TAT?
Acelerar Fase Analítica
Reducir el tiempo de procesado de muestras
Acelerar el transporte de muestras
Uso de plasma
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
Uso de suero o plasma
‘Analizando los mitos del plasma’
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
Balance de beneficios
Pureza TAT
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
Suero Plasma
Suero o plasma Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
Suero o plasma
Principales diferencias
• La barrera en plasma se forma
más rápidamente
• La barrera de plasma presenta
mayor contaminación de células
al quedar atrapadas en su
movimiento
• El plasma es más turbio que el
suero debido a las células que
no han sedimentado después de
formarse la barrera de gel
Suero
Plasma
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
Ventajas
– Virtualmente libre de células
– Buena estabilidad para muchos analitos
– Amplio rango de tests validados
– Menor TAT al centrifugar inmediatamente
– Movimiento más rápido del gel
– Mayor rendimiento que el suero (15-20%)
– Menor variabilidad en algunos analitos (K)
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
Inconvenientes
– Mayor TAT
– Interferencias de tests o instrumentos debido a fibrina
(especialmente en pacientes con terapia anticoagulante).
– Posibilidad de pseudohipercalemia
– Variación analítica por liberación de componentes de
plaquetas durante la coagulación
– Mayor recuento de células
– Menor estabilidad para algunos analitos
– Formación de fibrina durante almacenamiento
– Interferencias por el anticoagulante
– Interferencias por el fibrinógeno
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
¿Cuál es la compatibilidad del suero o
plasma en las distintas plataformas de
instrumentación?
Instrument Company Serum Plasma % Plasma % Range
Beckman Coulter N=20 1160 1106 95% 92% - 97%
Ortho J & J N=6 212 197 93% 89% - 100%
Siemens N=10 612 571 93% 90% - 97%
Abbott N=10 756 667 88% 78% - 95%
Roche N=11 613 520 85% 71% - 92%
BD review conducted in August 2015, non-published data
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
7 de Abril de 2016, Madrid
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
BD Vacutainer® Barricor™ Plasma Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
BD Vacutainer® Barricor™ Plasma Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
BD Vacutainer® Barricor™ – Rapidez
• Condiciones óptimas: 4000 g durante 3 minutos. Rango de centrifugación desde 1800 g durante 10 minutos (condiciones actuales de separación con gel)
• Procesamiento inmediato sin necesidad de 30 minutos de tiempo de coagulación
• Separación más rápida en solo 3 minutos
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
BD Vacutainer® Barricor™ – Gel/Fibrina
Separación sin gel
• Eliminación de reprocesamiento de muestras por gel
• Reducción de mantenimientos no programados*
• Claim not established data pending
• Tom Spiritus, Zahur Zaman, Walter Desmet, Iodinated Contrast Media Interfere with Gel Barrier
Formation in Plasma and Serum Separator Tubes, Clin. Chem., Jul 2003; 49: 1187 - 1189.
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
BD Vacutainer® Barricor™ – Estabilidad
BD White Paper VS9192, Evaluation of Analyte Performance (including cell count, plasma yield, visuals) at Various Centrifugation
Conditions (optimum vs recommended), 2016
Diferencia de recuentos celulares
BD Barricor™ Plasma vs
BD PST™II 4.5 mL
(difference with 95% CI)
Diffe
rence %
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
BD Vacutainer® Barricor™ – Estabilidad
Algunos analitos (AST, LDH, K, y Phos) son sensibles a
la contaminación celular en la muestra.
La muestra de plasma con menor contaminación celular
proporciona una estabilidad superior.
Analitos Suero Gel BD Barricor™ Plasma Plasma Gel
AST 7 días 4°C 3 días 4°C
LDH 7 días 4°C 3 días 4°C
K 7 días 4°C 3 días 4°C
Phos 7 días 4°C 3 días 4°C
BD Barricor™ Plasma
7 días 4°C
7 días 4°C
7 días 4°C
7 días 4°C
BD White Paper VS9295, Within-Tube Stability of Selected Routine Chemistry Analytes and Immunoassays in BD Vacutainer® Barricor™ Tubes
in Comparison with BD Vacutainer® PST™ II and SST™ II Advance Tubes at Multiple Time Points Post Centrifugation, 2016
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
6
7
8
9
10
11
12
13
14
15
0hr 24hr 48hr 72hr 7d
Co
nce
ntr
atio
n µ
g/m
L
Fenitoína (DxC)
6,5
7
7,5
8
8,5
9
9,5
10
10,5
11
0hr 24hr 48hr 72hr 7d
Co
nce
ntr
atio
n µ
g/m
L
Carbamazepina (DxC)
----- Serum aliquot ----- BD Barricor ----- Serum Gel
BD Vacutainer® Barricor™ – Fármacos
Initial BD Barricor data, data on file see BD White Paper VS9168, Comparison of the BD Vacutainer® Barricor™ Tube with the
BD Vacutainer® PST™ II Tube and BD Vacutainer® Serum Tube for Selected Therapeutic Drugs, 2016
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
Validación
BD Vacutainer® Barricor™
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
¿Qué tipo de información disponemos? Key Deliverables (using production
equivalent product)
Clinical Site
Confirmed/
Identified
(Target Date)
Clinical Site
Confirmed/
Identified
(Actual Date)
New/
Site
Qualification
(Target Date)
New
Site
Qualification
(Actual Date)
Design/
Synopsis
(Target
Date)
Design/
Synopsis
(Actual
Date)
CDA w/
new sites
(Target
Date)
CDA w/
new sites
(Actual Date)
Final
Protocol
(Target
Date)
Final
Protocol
(Actual
Date)
Final
Budget
(Target
Date)
Final
Budget
(Actual
Date)
CTA Submited
(Target Date)
CTA Submited
(Actual Date)
IRB
Submited
(Target
Date)
IRB
Submited
(Actual
Date)
IRB
Approval
(Target
Date)
IRB
Approval
(Actual
Date)
CTA
Executed
(Target
Date)
CTA
Executed
(Actual
Date)
Kitting
Protocol
Approval
(Target
Date)
Kitting
Protocol
Approval
(Actual
Date)
Kitting Date
(Target
Date)
Kitting Date
(Actual
Date)
Shipping
Date
(Target
Date)
Shipping
Date
(Actual
Date)
Site
Initiation
(Target
Date)
Site
Initiation
(Actual
Date)
1st Subj
Enrolled
(Target
Date)
1st Subj
Enrolled
(Actual
Date)
25% of
Enrollment
(Target
Date)
25% of
Enrollment
(Actual
Date)
50% of
Enrollment
(Target
Date)
50% of
Enrollment
(Actual
Date)
End of
Enrollment
(Target
Date)
End of
Enrollment
(Actual
Date)
Last Data
Transferred
(Target
Date)
Last Data
Transferred
(Actual
Date)
Data
Locked
(Target
Date)
Data
Locked
(Actual
Date)
Stat
Report
(Target
Date)
Stat
Report
(Actual
Date)
Clinical
Report
(Target
Date)
Clinical
Report
(Actual Date)
Critical Report
Dates
FDA
Summary
(Target Date)
FDA
Summary
(Actual
Date)
White Papers
(Target Date)
White Papers
(Actual Date) Comments
Institute and Location
Site
Agreement
Status
Data
NeededStudy Number CSM/ CRA
External S&E Clinical Trials for 510kChemistry
Routine
9140212c ID PAS-13USTUB23 CUH Czech
Charles University
Hospital,, Czech Republic
TBD
Pre-launch PAS-13USTUB23 AM/ NB 8/15/13 TBD N/A N/A 6/1/13 5/17/13 N/A N/A 4/18/14 4/17/14 4/30/14 4/28/14 5/1/17 5/1/17 5/1/17 4/21/14 5/27/14 5/16/14 5/30/14 5/29/14 5/1/14 4/23/14 5/14/14 4/29/14 6/2/14 5/6/14 6/23/14 5/21/14 5/30/14 5/30/14 7/15/14 7/7/14 9/1/14 7/24/14 2/1/15 2/16/15 2/27/15 3/13/15
3/13/2015
3/27/2015
4/3/2015
4/10/15 4/17/15
3/27/2015
4/10/2015
4/24/15
5/1/15 5/18/15 5/30/15 MA KBO
9140212c ID PAS-13USTUB18 chem Site 1 JTM, NY Gen
Chem/Anemia J.T. Mathers, NY
Verbal
Pre-launch PAS-13USTUB18 NN/ NB 6/15/13 5/31/13 6/1/13 5/17/13 N/A N/A 4/15/14 4/28/14 4/30/14 5/15/14 5/27/14 6/10/14 5/13/14 5/13/14 5/27/14 5/14/14 5/30/14 6/17/14 5/1/14 4/23/14 5/21/14 4/29/14
6/2/2014
6/23/14
N/A
(6/25/14 to
CRA)
6/2/2014
6/26/14 6/26/14
6/9/2014
6/30/14 7/21/14 8/12/14 8/8/14 8/29/14 8/27/14 12/31/14 2/23/15
1/30/2015
2/13/15
2/27/14 3/9/15
2/16/2015
2/27/15
3/13/15
3/27/15
4/3/15
4/10/15 4/9/15
3/2/2015
3/13/15
3/27/15
4/17/15
4/24/15 4/23/15
5/18/2015
4/30/15 5/30/15
Cardiac Markers:
9140212c ID PAS-13USTUB22 chem Site 2 MMRF,
Minn,Mn Cardiac/Anemia
Minneapolis Medical
Research Foundation, Mn
Verbal
Pre-launch PAS-13USTUB22 NB/SU 6/15/13 6/11/13 N/A N/A 6/1/13 5/17/13 N/A N/A
4/15/2014
5/27/14 6/4/14
4/20/14
5/27/14 6/3/14
4/30/2014
5/30/14 6/9/14
5/1/2014
5/27/14 6/4/14
5/15/14
6/15/14 6/18/14
5/16/14
6/6/14 6/18/14 5/9/14 4/23/14 5/19/14 4/24/14
5/27/2014
6/16/14 6/17/14
5/20/2014
6/18/14 6/18/14
5/30/14
6/23/14
8/25/14
9/15/14 10/9/14 11/7/14 12/7/14 12/7/14
2/1/2015
2/28/15
3/31/15 4/3/15
2/27/2015
3/31/15
4/15/15 4/8/15
3/13/2015
4/15/15
4/30/15 5/11/15
3/27/2015
4/30/15
5/15/15 5/19/15
5/18/2015
5/31/15
6/12/15 5/30/15
Revising test plan to
include TnT on the
NEW Roche e411
9140212c ID PAS-13USTUB22 chem Collection Site JTM,
NY J.T. Mather, NYVerbal
Pre-launch PAS-13USTUB22 NB/SU 1/23/15 1/23/15 N/A N/A N/A N/A N/A N/A 2/4/15 2/4/15 2/4/15 2/4/15 2/6/15 2/6/15 2/5/15 2/5/15 2/24/15 2/10/15 2/5/15 2/5/15 2/19/15 2/20/15 3/2/15 2/27/15 3/9/15 3/13/15 3/18/15 3/31/15 4/15/15 4/30/15 5/15/15 5/31/15 5/30/15
Fertility/Hormones,Cancer Markers and Thyroid
Function
9140212c ID PAS-13USTUB20 Collection Site #6 CUH
Czech
Charles University
Hospital,, Czech Republic
Verbal
Pre-launch PAS-13USTUB20 AM/ NB 6/1/13 5/20/13 11/15/13 8/15/13 6/1/13 5/17/13 6/15/13 5/20/13 4/18/14 4/17/14 4/30/14 4/28/14 5/1/17 5/1/17 5/1/17 4/21/14 5/27/14 5/16/14 5/30/14 5/29/14 5/1/14 4/23/14 5/14/14 4/24/14 6/2/14 5/6/14 6/23/14 5/20/14 6/30/14 6/18/14 8/15/14 7/31/14 10/1/14 9/16/14 2/1/15 2/24/15 2/27/15 3/13/15
3/13/2015
3/27/2015
4/10/2015
4/17/15 4/27/15
3/27/2015
4/10/2015
4/24/15
5/8/15
5/18/2015
5/25/15 5/30/15
9140212c ID PAS-13USTUB21 Collection Site #7 Merate,
Italy
Ospedale San Leopoldo
Mandic, Italy
Verbal
Pre-launch PAS-13USTUB21 AM/ NB 6/1/13 5/20/13 11/15/13 8/15/13 6/1/13 5/17/13 6/15/13 5/20/13 4/18/14 4/17/14 4/30/14 4/21/14 5/1/17 5/1/17 5/1/17 5/15/14 5/27/14 10/13/14 5/30/14 10/31/14 5/1/14 4/23/14 5/14/14 4/25/14 6/9/14 6/9/14
6/23/14
6/19/14 6/19/14
6/30/2014
9/15/14
12/17/14 12/17/14 1/16/15 1/16/15 1/30/15 1/23/15 2/28/15
3/13/2015
3/20/15 3/31/15
3/27/2015
4/14/15 5/22/15 5/30/15
Specific Protein:
9140212c ID PAS-13USTUB19 chem Site 6 IDACV Va,
Special Chem
Infectious Diseases
Associates of Central
Virginia. Lynchburg, VA
Formal Approval
Pre-launch PAS-13USTUB19 SJ/ NB 6/15/13 6/12/13 N/A N/A 6/1/13 5/17/13 N/A N/A 4/16/14 4/17/14 4/1/14 4/1/14 4/2/14 4/24/14 4/22/14 4/30/14 5/16/14 5/21/14 5/24/14 5/15/14 4/30/14 4/23/14 5/12/14 4/23/14 5/27/14 5/21/14 5/28/14 5/28/14
6/3/2014
5/30/14 5/30/14 7/15/14 6/30/14 9/15/14 7/31/14
12/31/2014
3/3/15
3/9/15 3/9/15
1/30/2015
2/9/15 3/6/15
3/13/15
3/20/15 3/20/15
2/16/2015
2/17/15
2/23/17
3/27/15 3/27/15
3/16/2015
3/3/15
3/9/15
4/3/15 4/1/15
5/18/2015
4/30/15
5/8/14 5/13/15 5/30/15
1/13/14
IFD
IFD Dx
9140212c ID PAS-14USTUB02 HCMC, Minn, Mn Diag HCMC, Minneapolis, Mn
Formal Approval
Pre-launch PAS-14USTUB02 SJ/ TW 5/21/13 5/29/13 8/28/13 6/20/13 1/20/14 1/23/14 n/a n/a 4/16/14 4/18/14 4/16/14 4/25/14 3/14/14 3/21/14
4/30/2014
5/15/14 5/19/14 6/13/14 5/28/14 5/9/14 5/14/14 3/17/14 5/2/14 4/1/14 5/13/14
4/24/2014
6/16/14 6/10/14 6/18/14 6/18/14 6/23/14 7/10/14 9/15/14 10/15/14 11/1/14 1/21/15
1/30/2015
5/1/15
5/29/15
6/30/15
2/6/2015
5/8/15
6/8/15
7/10/15
3/1/2015
6/1/15
6/15/15
7/24/15
3/14/2015
6/16/15
7/1/15
8/7/15
4/28/2014
7/15/15
7/30/15
9/4/15 7/30/15
9140212c ID PAS-14USTUB02 SNBL,Md Diag SNBL, Baltimore, Md
Formal Approval
Pre-launch PAS-14USTUB02 SJ/ TW 5/31/13 5/29/13 6/12/13 6/6/13 1/20/14 1/23/14 4/19/13 4/19/13 4/16/14 4/18/14 4/2/14 4/2/14 3/14/14 4/2/14 4/25/14 5/2/14 5/15/14 5/21/14 4/18/14 4/30/14 3/17/14 5/2/14 4/1/14 5/6/14
4/14/2014
5/21/14 5/21/14 5/20/14 5/20/14 5/22/14 5/29/14 7/31/14 7/31/14 11/1/14 8/29/14
1/30/2015
5/1/15
5/29/15
6/30/15
2/6/2015
5/8/15
6/8/15
7/10/15
3/1/2015
6/1/15
6/15/15
7/24/15
3/14/2015
6/16/15
7/1/15
8/7/15
4/28/2014
7/15/15
7/30/15
9/4/15 7/30/15
Site 2 (collection) - IDACV Va Dr. Brennan
Infectious Diseases
Associates of Central
Virginia. Lynchburg, VA
Formal Approval
Pre-launch PAS-14USTUB02 SJ/ TW 1/31/14 1/31/14 n/a n/a 1/20/14 1/23/14 n/a n/a 4/16/14 4/18/14
4/18/2014
5/29/14 6/4/14 4/23/14 4/24/14
4/30/2014
6/6/14 6/11/14
5/28/2014
6/27/14 7/1/14
4/28/2014
6/2/14 6/18/14 3/17/14 5/2/14 7/1/14 6/10/14
5/21/2014
7/8/14
7/14/14 7/14/14
6/28/2014
7/9/14
8/26/14 8/26/14
7/11/2014
1/26/15 3/11/15 N/A N/A N/A N/A
1/30/2015
5/1/15
5/29/15
6/30/15 n/a
3/1/2015
6/1/15
6/15/15
7/24/15
3/14/2015
6/16/15
7/1/15
8/7/15
4/28/2014
7/15/15
7/30/15
9/4/15 7/30/15
Site 3 (collection) - GCRBCC Tx Dr. Rossman
Gulf Coast Regional Blood
Center, Houston, Tx
Verbal
Pre-launch PAS-14USTUB02 SJ/ TW 1/31/14 1/31/14 n/a n/a 1/20/14 1/23/14 n/a n/a 4/16/14 4/18/14 3/13/15 3/13/15 3/16/15 3/16/15 3/18/15 3/18/15 4/1/15 4/1/15 4/3/15 3/9/15 3/9/15 3/25/15 3/25/15 4/6/15 4/9/15 4/10/15 N/A N/A N/A N/A
1/30/2015
5/1/15
5/29/15
6/30/15 n/a
3/1/2015
6/1/15
6/15/15
7/24/15
3/14/2015
6/16/15
7/1/15
8/7/15
4/28/2014
7/15/15
7/30/15
9/4/15 7/30/15
Repeatability
Site 2 (collection and testing) - IDACV Va Dr. Brennan
Infectious Diseases
Associates of Central
Virginia. Lynchburg, VA
Formal Approval
Pre-launch PAS13USTUB14 SJ/ TW 6/20/13 6/20/13 n/a n/a 7/22/13 7/22/13 n/a n/a
5/18/2014
6/20/14
8/8/14 8/19/14
5/15/2014
6/27/14
7/31/14 8/7/14
4/30/2014
5/30/14 7/1/14
5/27/2014
6/27/14
8/12/14 8/21/14
6/17/2014
7/18/14
8/26/14 9/9/14
5/20/2014
8/18/14 8/25/14
5/21/2014
8/9/14 8/21/14 8/1/14 8/25/14
6/25/2014
8/6/14 9/9/14
6/24/2014
8/7/14
8/26/14 8/26/14
7/1/2014
8/13/14
9/1/14
9/18/14 9/18/12 9/22/14 10/26/14 9/25/14 10/26/14
8/12/2014
9/15/14
12/12/14
1/14/15 2/19/15
8/19/2014
9/19/14
12/19/14
1/16/15 3/3/15
8/29/2014
10/3/14
1/9/15
2/6/15
2/20/15
2/27/15
3/11/15 3/9/15
9/12/2014
10/17/14
1/23/15
2/20/15
3/6/15
3/18/15 3/18/15
10/31/2014
2/27/15
3/31/15
4/20/15
5/20/15
6/10/15 7/30/15
Spiking
Site 10 (Ship materials) - SeraCare Pre-launch PAS-14USTUB02 8/13/14 9/30/14 7/30/15
TDM
9140212c PAS-13USTUB37 TDM Collection & Testing Dr
Christenson
Univ of Maryland,
Baltimore, MD
Verbal
Pre-launch PAS-13USTUB37 SM/ DS n/a n/a n/a n/a 11/20/13 11/20/13 01 2014 12/9/13 1/16/14 1/1/14 2/28/14 2/28/14
2/1/2014
2/28/14 2/28/14 2/3/14 2/4/14 2/14/14 2/11/14 2/25/14 3/6/14 2/4/14 2/12/14 3/30/14 3/11/14
10/31/2014
11/30/2014 1/16/15
11/15/2014
12/15/2014
2/2/15
12/1/2014
1/1/20
2/13/15
12/19/2014
1/19/2015
2/28/15
2/27/15
3/5/15
3/13/15
3/27/15
1/31/2015
2/28/2015
3/31/15
4/30/155/28/15 4/30/15
9140212c PAS-13USTUB37 TDM Collection Site #2
UCSF, Dr. Wu Dr Alan Wu UCSF, San Francisco, Ca
Verbal
Pre-launch PAS-13USTUB37 SM/ DS n/a n/a n/a n/a 11/20/13 11/20/13 01 2014 11/13/13 1/16/14 1/1/14 2/28/14 2/28/14
2/1/2014
2/28/14 2/28/14 2/3/14 2/4/14 2/14/14 2/11/14 2/25/14 3/6/14 2/18/14 2/26/14 3/30/14 3/12/14
10/31/2014
11/30/2015 11/30/15
11/15/2014
12/15/2014 12/15/14
12/1/2014
1/1/20
2/13/15
12/19/2014
1/19/2015
2/28/15
2/27/15
3/5/15
3/13/15
3/27/15
1/31/2015
2/28/2015
3/31/15
4/30/155/28/15 4/30/15
9140212c PAS-13USTUB37 TDM Collection Site #3 JTM,
NY Dr Geiger
J. T. Mather New York,
NY
Verbal
Pre-launch PAS-13USTUB37 SM/ DS n/a n/a n/a n/a 11/20/13 11/20/13 01 2014 1/8/14 1/16/14 1/14/14 2/28/14 2/28/14
2/1/2014
2/28/14 2/28/14 2/3/14 2/4/14 2/14/14 2/11/14 2/25/14 3/6/14 2/11/14 3/18/14 3/30/14 3/12/14
10/31/2014
11/30/2016 11/30/15
11/15/2014
12/15/2014 12/15/14
12/1/2014
1/1/20
2/13/15
12/19/2014
1/19/2015
2/28/15
2/27/15
3/5/15
3/13/15
3/27/15
1/31/2015
2/28/2015
3/31/15
4/30/155/28/15 4/30/15
9140212c PAS-13USTUB37TDM Collection Site #4 Czech,
Dr.Palicka
Charles University
Hospital,Czech Republic
Verbal
Pre-launch PAS-13USTUB37 SM/ DS n/a n/a n/a 4/9/13 11/20/13 11/20/13 01 2014 12/9/13 1/28/14 12/12/13 2/12/14 1/9/14 3/31/14 3/31/14
2/1/2014
5/30/14 5/30/14 2/3/14 2/4/14 2/14/14 2/11/14 2/25/14 3/18/14 3/1/14 4/4/14
5/15/2014
5/30/14 6/2/14
10/31/2014
11/30/2017 11/30/15
11/15/2014
12/15/2014 12/15/14
12/1/2014
1/1/20
2/13/15
12/19/2014
1/19/2015
2/28/15
2/27/15
3/5/15
3/13/15
3/27/15
1/31/2015
2/28/2015
3/31/15
4/30/155/28/15 4/30/15
9140212c PAS-13USTUB37 TDM Collection Site #5
Czech,Dr Prusa
Motol Hospital, Czech
Republic
Verbal
Pre-launch PAS-13USTUB37 SM/ DS n/a n/a 5/31/13 5/14/13 11/20/13 11/20/13 01 2014 12/17/13 1/28/14 12/12/13 2/12/14 1/8/14 3/31/14 3/31/14
2/1/2014
5/30/14 5/20/14 2/3/14 2/4/14 2/14/14 2/11/14 2/25/14 3/18/14 3/1/14 4/3/14
5/15/2014
5/30/14 7/23/14
10/31/2014
11/30/2018 11/30/15
11/15/2014
12/15/2014 12/15/14
12/1/2014
1/1/20
2/13/15
12/19/2014
1/19/2015
2/28/15
2/27/15
3/5/15
3/13/15
3/27/15
1/31/2015
2/28/2015
3/31/15
4/30/155/28/15 4/30/15
9140212c PAS-13USTUB37 Collection Site #6 Czech, Dr
Zima
First Faculty of Medicine
and General University
Hospital, Czech Republic
Verbal
Pre-launch PAS-13USTUB37 SM/ DS 7/31/13 6/11/13 11/20/13 11/20/13 01 2014 1/1/14 1/28/14 12/12/13 2/12/14 1/13/14 4/30/14 4/30/14
2/1/2014
6/15/14 6/13/14 2/3/14 2/4/14 2/14/14 2/11/14 2/25/14 3/18/14 3/1/14 4/2/14
5/15/2014
6/15/14 7/9/15
10/31/2014
11/30/2019 11/30/15
11/15/2014
12/15/2014 12/15/14
12/1/2014
1/1/20
2/13/15
12/19/2014
1/19/2015
2/28/15
2/27/15
3/5/15
3/13/15
3/27/15
1/31/2015
2/28/2015
3/31/15
4/30/155/28/15 4/30/15
9140212c PAS-13USTUB37 Collection Site #7 Dr
Petersman
University Hospital
Greifswald, Germany
Verbal
Pre-launch PAS-13USTUB37 GP/ DS 7/31/13 7/23/13 11/20/13 11/20/13 01 2014 pending 1/28/14 pending ??? 2/1/14 3/31/14 3/31/14
2/1/2014
6/15/14 6/20/14 2/3/14 2/4/14 2/14/14 2/11/14 2/25/14 4/10/14 3/18/14 4/1/14
5/15/2014
6/15/14
10/31/2014
11/30/2020 8/31/14
11/15/2014
12/15/2014 12/15/14
12/1/2014
1/1/20
2/13/15
12/19/2014
1/19/2015
2/28/15
2/27/15
3/5/15
3/13/15
3/27/15
1/31/2015
2/28/2015
3/31/15
4/30/155/28/15 4/30/15
Received signoff on
CSR from A.
Petersmann on 28
May 2015
Site 8 (collection) - TBD Canada ??? Canada ?? TBD Pre-launch TBD SM/ DS n/a n/a n/a n/a n/a n/a n/a n/a n/a
Internal S&E Clinical Trials for 510k
submission
7 day Analyte Stability (chemistry) PLASMA On-site FLKSN/A
Pre-launch PAS13USTUB24 LK n/a n/a n/a n/a 5/17/13 7/8/13 n/a n/a
2/24/2014
6/22/2015 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 01/06/2015 23/06/2015 n/a n/a n/a n/a
3/3/2014
7/8/2015
3/28/2014
8/18/2015
4/11/2018
8/20/2015
4/18/2014
9/2/15
4/25/2014
9/16/2015
5/30/2014
10/4/2015 10/27/15
Verification / Shelf Life - Initial (t=0) PLASMA On-site FLKS
N/A
Pre-launch PAS13USTUB39 SJ / TW n/a n/a n/a n/a n/a n/a n/a n/a 1/6/14 1/16/14 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 06/01/2014 1/7/14 1/30/14 1/28/14 1/31/14 1/31/14 2/7/14 2/7/14 2/14/14 2/14/14
3/31/2014
12/31/14
1/31/15 3/11/15
Shelf Life - Mid Point (6m) PLASMA On-site FLKS
N/A
Pre-launch PAS14USTUB12 SJ / TW n/a n/a n/a n/a n/a n/a n/a n/a
7/1/2014
6/20/2014 7/8/14 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 20/06/2014 6/18/14 23/06/2014 6/23/14 n/a n/a n/a n/a 08/07/2014 7/21/14
8/13/2014
8/18/14 8/4/14
8/18/2014
8/19/2014 8/5/14
8/29/2014
9/2/2014 9/8/14 9/16/14 9/16/14
11/10/2014
1/31/15
3/11/15 3/18/15
Shelf Life - Mid Point (12m) PLASMA On-site FLKSN/A
Pre-launch PAS14USTUB12 DP / SA n/a n/a n/a n/a n/a n/a n/a n/a
1/6/2015
12/18/2014 12/22/14 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 18/12/2014 12/22/14 19/12/2014 n/a n/a n/a n/a 12/01/2015 1/12/15 1/21/15
2/17/2015
2/20/2015 2/4/15
2/20/2015
2/23/2015 2/11/15
3/2/2015
3/6/2015 3/6/15
3/20/2015
3/27/2015 3/19/15
5/18/2015
4/24/2015 5/29/15 5/30/15
Shelf Life - E + 1 (19m) PLASMA On-site FLKSN/A
Pre-launch PAS14USTUB12 DP / SA n/a n/a n/a n/a n/a n/a n/a n/a
8/6/2015
8/4/2015 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 04/08/2015 05/08/2015 n/a n/a n/a
8/12/2015
8/19/2015
9/18/2015
9/30/2015
9/23/2015
10/1/2015
10/7/2015
10/14/2015
10/21/2015
10/28/2015
12/17/2015
11/30/2015 12/3/15
13 X 75 Verification / Shelf Life - Initial (t=0) PLASMA On-site FLKS
N/A
Pre-launch PAS14USTUB10 SJ / TW n/a n/a n/a n/a n/a n/a n/a n/a
4/18/2014
5/20/2014 5/22/14 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 5/21/14 23/05/2014 6/20/14 n/a n/a n/a n/a
4/25/2014
5/23/14 5/23/14
6/24/2014
7/6/14 7/16/14
6/27/2014
7/7/14 7/17/14
7/4/2014
7/14/2014 7/14/14
7/18/2014
8/4/14
8/27/14 8/27/14
8/31/2014
10/30/14
1/31/15
3/6/15
5/29/15 5/29/15 5/4/15
13 X 75 Shelf Life - Mid Point (6m) PLASMA On-site FLKS
N/A
Pre-launch PAS14USTUB13 DP / SA n/a n/a n/a n/a n/a n/a n/a n/a
11/11/2014
11/7/2014 11/11/14 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 04/11/2014 05/11/2014 11/18/14 n/a n/a n/a n/a 11/19/14 11/19/14 11/25/14 12/8/14 12/8/14
12/31/2014
1/8/2015 12/22/14
1/8/2015
1/9/2015 1/6/14
1/18/2015
1/22/2015 1/22/15 05/02/2015 2/6/15
4/16/2015
2/27/2015
4/6/2015 5/15/15 5/25/15
13 X 75 Shelf Life - Mid Point (12m) PLASMA On-site FLKSN/A
Pre-launch PAS14USTUB13 DP / TW n/a n/a n/a n/a n/a n/a n/a n/a
5/12/2015
5/8/2015 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 08/05/2015 11/05/2015 n/a n/a n/a
5/18/2015
5/26/2015 5/26/15 6/10/15
6/25/2015
7/7/2015
6/29/2015
7/8/2015
7/6/2015
7/21/2015
7/28/2015
8/4/2015
9/20/2015
8/25/2015 9/15/15
13 X 75 Shelf Life - E + 1 (19m) PLASMA On-site FLKSN/A
Pre-launch PAS14USTUB13 DP / TW n/a n/a n/a n/a n/a n/a n/a n/a
12/9/2015
11/25/2015 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 25/11/2015 30/11/2015 n/a n/a n/a 12/14/15
9/7/2015
1/28/2016
1/28/2016
1/29/2016
2/18/2014
2/19/2016 04/03/2016
11/17/2015
3/25/2016 3/25/15
Heparin Activity On-site FLKS N/A Pre-launch TBD
<24 hr Analyte Stability (chemistry) if needed On-site FLKSN/A
Pre-launch PAS-14USTUB29 LK n/a n/a n/a n/a n/a n/a
4/1/2014
10/7/2015 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 07/10/2015 12/10/2015 n/a n/a n/a
4/25/2014
10/15/2015
4/27/2014
10/28/2015
4/28/2014
10/29/2015
5/1/2014
11/11/2015
5/16/2014
11/30/2015 29/12/2015 1/15/16
Analyte Stability at RT @24h, 48h, 72h (Marketing study) On-site FLKS
N/A
PAS14USTUB21 LK n/a n/a n/a n/a 30/09/2014 10/8/14 30/09/2014 30/09/2014 14/10/2014 14/10/2014 11/11/2014 11/11/2014 11/11/2014
11/25/2014
2/9/2015 02/02/2015
12/18/2014
2/23/2015 11/02/2015
1/15/2015
3/31/2015
4/20/2015 5/25/15
Lot -Lot Repeatability Plasma (Spiked PSA)
(Evaluate Freeze/Thaw Cycle in Situ) On-site FLKS
N/A
Pre-launch PAS14USTUB31 LK n/a n/a n/a n/a n/a n/a n/a n/a
4/14/2014
4/24/2015
4/30/2015 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 24/04/2015
4/27/2015
5/4/2015 n/a n/a n/a
4/25/2014
5/11/2015
12/31/2013
5/26/2015
1/13/2014
5/27/2015
1/28/2014
6/10/2015
2/15/2014
6/24/2015
7/14/2015
7/22/2015
Prep of Spiked Samples (To supplement TDMs for PAS-
13USTUB37) On-site FLKS
N/A
Pre-launch PAS-14USTUB16 LM /SR n/a n/a n/a n/a n/a n/a
8/4/2014
8/15/14
1/19/15 1/19/15 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 04/08/2014 05/08/2014 n/a n/a n/a
8/19/2014
9/2/2014
1/19/15 20/01/2015
9/2/2014
1/21/15 1/21/15
9/30/2014
1/2015 n/a n/a n/a 4/30/15
Prep of Spiked Samples (General Chemistry) On-site FLKSN/A
Pre-launch PAS-14USTUB18 NN n/a n/a n/a n/a n/a n/a n/a n/a 14/10/2014 10/21/14 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 14/10/2014 15/10/2014 11/3/14 11/10/14
10/29/2014
11/11/14 02/12/2014 23/12/2014 26/01/2015 2/1/15 n/a n/a 2/28/15 5/30/15 n/a n/a
Prep of Spiked Samples (Gen. Chem -Whole Blood Stability)On-site FLKS
N/A
Pre-launch PAS-14USTUB19 NN/ SR / SA n/a n/a n/a n/a n/a n/a n/a n/a 27/08/2014 10/9/14 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 27/08/2014 10/6/14 28/08/2014 10/24/14 10/24/14 12/09/2014 27/10/2014 14/10/2014 14/10/2014 28/10/2014 28/01/2015
11/11/2014
1/15/2015
3/27/2015
2/5/2015
3/26/2015
12/4/2014
4/15/2015
4/20/2015
5/30/2015 5/30/15
need for functional
review- deprioritized
Prep of Spiked Samples (TDM -Whole Blood Stability) combined w Gen ChemOn-site FLKS N/A Pre-launch
Prep of Spiked Samples (TDM - Precision study) On-site FLKSN/A
Pre-launch PAS-15USTUB02 LM / SR / DS n/a n/a n/a n/a n/a n/a n/a n/a 12/02/2015 24/02/2015 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 12/02/2015 24/02/2015 13/02/2015 25/02/2015 n/a n/a n/a n/a 02/03/2015 02/03/2015 13/03/2015 13/03/2015 20/03/2015 17/03/2015 03/04/2015 09/04/2015 17/04/2015 22/04/2015
5/8/2015
5/22/2015 20/05/2015 27/05/2015
Prep of Spiked Samples (TDM - Stability @ End of Shelf Life)On-site FLKSN/A
Pre-launch PAS-15USTUB03 LM / SR / ? n/a n/a n/a n/a n/a n/a n/a n/a 07/09/2015 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 16/09/2016 17/09/2015 n/a n/a n/a n/a 22/09/2015 07/10/2015 14/10/2015 04/11/2015 11/11/2015 11/12/2015 28/12/2015
monitor & DM not
assigned
Verification Non-Clinical for 510k submissionAnalytical testing of zinc (total extractable zinc)- CPD Pre-launch CPD n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a
Material extractable, biocompatebility- CPD Pre-launch CPD n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a
Marketing (Other)
Stability of T3, T4, FT3, FT4 and TSH in BD Plasma
Cyclops using Multiple Platforms at over 7 days Offsite/TBD Pre-launch PAS-15USTUB05 DP/AC 3/17/15 3/27/15 n/a n/a 2/24/15 2/24/15 n/a n/a 4/14/15 5/1/15 3/30/15 4/6/15 4/8/15 4/15/15 5/19/15 5/19/15 5/1/15 5/8/15 5/13/15 5/21/15
5/26/2015
6/29/2015
7/6/2015
7/24/2015
7/20/2015
8/7/2015
8/4/2015
8/28/2015
8/18/2015
9/11/2015
9/22/2015
10/162015 10/13/15
Centrifugation DOE (13x100) incl cell cout - plasma Part A On-site FLKS
N/A
Pre-launch PAS-14USTUB03 ND n/a n/a n/a n/a 6/17/13 8/5/13 n/a n/a
5/30/2014
8/18/2014 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 8/18/14 8/19/14 8/19/14 9/5/14 n/a 9/11/14 9/11/14
6/2/2014
9/17/2014 9/3/14 9/9/14 9/16/14
6/29/2014
10/28/2014 9/29/14
6/30/2014
10/29/2014
7/1/2014
11/11/2014 11/14/14
7/17/2014
11/25/2014 12/1/14
12/18/2014
2/15/2015
4/30/2015
Centrifugation DOE (13x75) incl cell count - plasma Part A On-site FLKS
Pre-launch PAS-14USTUB11 DP n/a n/a n/a n/a 17/06/2013 05/08/2013 n/a n/a
10/10/2014
2/5/2015 05/02/2015 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 05/02/2015 09/02/2015 06/02/2015 n/a n/a 20/02/2015 20/02/2015
10/20/2014
2/23/2015 23/02/2015 ######## ########
11/10/2014
4/17/2015 26/03/2015
11/14/2014
4/20/2015 26/03/2015
11/30/2014
5/1/2015
4/17/2015
4/29/2015 01/05/2015
12/12/2014
5/15/2015 15/05/2015 08/06/2015 22/06/2015
Stressed Handling PLASMA
(Cancelled; merged with 14TUB27) On-site FLKS
N/A
Pre-launch PAS-14USTUB34 LK n/a n/a n/a n/a n/a n/a
4/28/2014
4/3/2015
4/13/2015 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 03/04/2015
4/6/2015
4/10/2015
5/5/2014
4/20/2015
5/14/2014
5/8/2015
5/11/2015
5/16/2014
5/11/2015
5/23/2014
5/25/2015
5/30/2014
6/8/2015
6/29/2015
7/6/2015
cancelled -combined
with PAS14USTUB27
Competitor Tube Study (Greiner) Plasma On-site FLKS
N/A
Pre-launch PAS-14USTUB27 LK n/a n/a n/a n/a 5/10/13
7/31/2013
11/7/14 n/a n/a
4/20/2015
3/9//15
3/25/2015 4/21/15 n/a n/a n/a n/a
3/9/2015
3/20/2015
4/13/15 4/15/15
3/13/2015
3/23/2015 4/20/15
8/25/2014
3/23/2015
3/30/2015
4/22/15 4/29/15 5/6/15
2/20/2015
4/17/2015
4/24/2015
5/22/15
2/24/2015
4/17/2015
4/27/2015
5/27/15
4/5/2015
5/1/2015
5/8/2015
6/24/15
4/18/2015
5/15/2015
7/22/2015
6/12/2015
8/22/15 8/28/15
Competitor Tube Study (Sarstedt) Plasma On-site Oxford N/A Pre-launch PAS-13USTUB28 LK/KF n/a n/a n/a n/a 1/20/15 10/1/15 10/4/15 16/12/2015 30/12/2015
Competitor Tube Study (Terumo, Sekesui) Plasma On-site FLKS N/A Pre-launch TBD LK/XX n/a n/a n/a n/a 5/10/13 7/31/13 n/a n/a 3/23/15 n/a n/a n/a n/a 11/9/15 12/21/15 12/26/15 15/01/2016 30/01/2016
Competitor Tube Study (Ayset,) Plasma On-site FLKS N/A Pre-launch TBD LK/XX n/a n/a n/a n/a 11/9/15 12/21/15 12/26/15 15/01/2016 30/01/2016
Competitor Tube Study ( Improv) Plasma On-site FLKS N/A Pre-launch TBD LK/XX n/a n/a n/a n/a 5/10/13 7/31/13 n/a n/a 4/10/15 n/a n/a n/a n/a 11/9/15 12/21/15 12/26/15 15/01/2016 30/01/2016
Analyte performance at various centrifugation conditions On-site FLKS Post - Launch TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD
Evaluation of Plasma Cell Counts (part A) &
Distribution of Cells in a Plasma Coumn (part B) On-site FLKSN/A
Pre-launch PAS-15USTUB06 SR / ? n/a n/a n/a n/a n/a n/a n/a n/a 28-Aug-15 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 04-Sep-15 08-Sep-15 05-Oct-15 06-Oct-15 20-Oct-15 03-Nov-15 01-Dec-15 12/1/15
Evaluation of Vitamin B12 On-site FLKS N/A Pre-launch PAS-15USTUB07 SR / AC n/a n/a n/a n/a n/a n/a n/a n/a 08-Jun-15 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 12-Jun-15 15-Jun-15 10-Jul-15 13-Jul-15 27-Jul-15 10-Aug-15 07-Sep-15 9/8/15
Drugs of Abuse On-site FLKS Post - Launch TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD
External Verification Clinical Trials (Other)Common TDMs using LDT (LC/mass spec based)-
(Cancelled- Serum study) Cancelled- serum cyclopsTBD
Post -launch TBD LM
Mass Spec: 1) Vit D, testosterone - Dr. Wu 2) MS sample
characterization -2nd site
UCSF, San Francisco, CA
+ MSKTBD
Pre-launch PAS-14USTUB32 LM 11/30/14 11/30/14 11/15/14
1/15/2015
TBD TBD TBD TBD TBD TBD TBD TBD TBD
3/21/2015
TBD
3/31/2015
TBD
6/30/2015
TBD
7/15/2015
TBD
7/30/2015
TBD
8/31/2015
TBD
10/31/2015
TBD NA
Lab-developed tests (HPLC/MS) TBD TBD Post -launch TBD LM
Clinical testing for Drugs of Abuse that are sensitive to gel- TBDTBD TBD Post -launch TBD LM
Verification Non-Clinical (Other)Barrier integrity at extreme temperature conditions
(post collection) R&D n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a
Pneumatic Tube Transportation R&D n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a
Temperature excursion over pre-use storage;
Impact on barrier properties and vacuum R&D n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a
UsabilityGeneral workflow- plasma Sweden pre-launch PAS-13USTUB40 MP 11/1/13 11/1/13 12/1/13 12/8/13 11/1/13 11/30/13 4/1/14 N/a 5/9/14 5/9/14 5/13/14 5/15/14 5/14/15 5/16/14 5/16/14 5/27/14 5/30/14 6/30/14 N/a N/a
General workflow- plasma MSKCC pre-launch PAS-14TUB09 MP 3/1/14 3/15/14 12/1013 6/6/14 N/A 6/15/14 N/A 7/6/14 7/10/14 7/21/14 7/25/14 7/29/14 8/6/14 8/20/14 9/22/14 N/a N/a
Platform Expansion Studies
PAS14USTUB28 Off Site Pre-launch PAS-14USTUB28 NB/TW 12/5/14 1/28/15 N/A 1/7/15 1/9/15
1/19/2015
1/30/15 1/9/15 1/14/15 1/9/15 1/12/15
1/26/2015
5/22/15
1/26/2015
5/22/2015 1/13/15 1/13/15 1/23/15
2/6/2015
5/22/2015
1/30/2015
2/10/15
5/26/2015 2/11/15
2/4/2015
2/11/15
3/16/15
5/27/15 5/1/15
2/20/2015
6/5/2015
3/6/2015
6/12/2015
4/15/2015
6/19/2015
6/26/2015
4/30/2015
6/22/2015
7/2/2015
5/15/2015
7/3/2015
7/17/2015
6/1/2015
7/17/2015
7/31/2015
7/20/2015
8/3/2015
8/14/2015 9/24/15
Siemens Advia Centaur XP IA System On-site FLKs n/a
Siemens Immulite 1000/2000
Hitachi High-Tech 7180 Chemistry analyzer Post -launch Regional
Toshiba Medical TBA-120FR similar to Abbott Architect Post -launch Regional
Nihondenshi/ Joel LCA 6050 Post -launch Regional
Fujirebio Lumipulse Presto II Post -launch Regional
Support StudiesPlasma Cyclops and Troponin Flyers Post -launch TBD ND/SM
Platform Expansions for Japanese instruments Covered in regional plansSee above?
Model of Barrier Integrity/stability - Pneumatic Tube
System (PTS) impact
Spray Pattern support data
Barrier Integrity/stability - Post collection Temperature fluctuation
Barrier Integrity/stability - PTS impact post centrifugation
Performance under variety of stress handling condition
Product Storage temperature Covered in R&D plan
TDM/Infectious Disease with Freezing Post launch
TDM/Infectious Disease under freeze/thaw conditions Post launch
Analyte performance at various centrifugation conditions
TDM Expansion - Additional 8 TDMs post launch/regional Off-site LM
TDM Stability at 48 hrs and room temperature
TDM Expansion - Additional Platforms- post launch/regional
Japan General Testing Covered in regional plans
Japan Value Proposition for Plasma in hospitals Covered in regional plans
Japan transportation pratices in CCL
HEOR StudiesImprovement of false positive rates in high sensitivity
assays (Cyclops Plasma)- Pre/Post retrospective data
collection Off-site
On Hold PAS-14USTUB22
SJ
1/30/2015
3/20/15
2/13/2015
3/27/159/25/14 9/25/14 2/6/15
2/20/2015
3/6/153/20/15
2/27/2015
3/27/15
2/16/2015
3/27/15TBA or N/A TBD or N/A
3/13/2015
3/31/15NA NA NA
3/20/2015
4/1/154/1//2015 NA NA NA 7/31/17 8/31/17 9/22/17 10/31/17 12/1/17 TBD
Reduced Instrument Maintenance and Sample Probe
Replacement (Plasma Cylops) Off-site ND 8/30/14 12/1/14 12/15/14 1/1/15 5/30/15 6/1/15 6/30/15 11/1/15 12/15/15
Evaluation of the Performance of Plasma Cyclops for the
Reduction of Poor Sample Quality Due to Short Clotting
Time. Off-site AM
Evaluation of the Performance of Plasma Cyclops for the
Reduction in Rate of Visual Inspections, Manual
Remediation and Recollection of Rejected Samples. Off-site AM
Evaluation of the Performance of Plasma Cyclops for false
positive HBsAg results Off-site PAS-15USTUB16 SJ
All HEOR Studies
will be conducted
under one protocol
which is TBD
39
Estudios
clínicos
7
Paises
490
Analitos/
instrumentos
21
Hospitales
264,000
resultados 16250
Tubos extraidos
5 evaluaciones en entorno hospitalario
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
Analitos e instrumentos: Bioquímica/Inmunoquímica Analyte Instrument Analyte Instrument Analyte Instrument
ALT/GPT 7, 9 LDL 7, 9 Free T3 8,10
Albumin 7, 9 Lipase 7, 9 Free T4 8, 10
Alk Phos 7, 9 Magnesium 7, 9 Total T3 2, 8
Amylase 7, 9 Phosphorus 7, 9 Total T4 8, 10
AST/GOT 7, 9 Potassium 7, 9 TSH 8, 10
Direct Bilirubin 7, 9 Sodium 7, 9 Total PSA 3, 11
Total Bilirubin 7, 9 Total Protein 7, 9 Cortisol 3, 8
BUN 7, 9 Triglycerides 7, 9 Estradiol 8, 10
Calcium 7, 9 Uric Acid 7, 9 FSH 8, 10
CO2 7, 9 CKMB 2, 5 βHCG 3, 8
Chloride 7, 9 Troponin I 2, 5 LH 8, 10
Cholesterol 7, 9 Troponin T 3 Progesterone 3, 8
CK 6, 9 Complement C3 1, 8 Testosterone 3, 8
Creatinine 7, 9 IgG 1, 8 Ferritin 1, 5
GGT 7, 9 IgA 1, 8 Folate 1, 2
Glucose 7, 9 IgM 1, 8 Vitamin B12 1, 5
HDL 7, 9 C-Reactive Protein 1, 8 RF 9, 7
Total Iron 7, 9 Haptoglobin 1, 8
LDH 7, 9 Transferrin 1, 8
1. Beckman Coulter DXC/DxI 5. Siemens ADVIA Centaur 9. BCI AU680
2. Beckman Coulter Access 2 6. Siemens Dimension 10. Siemens Vista 1500
3. Roche COBAS e411 7. Roche Modular 11. Ortho Vitros ECi
4. Roche Elecsys 2010 8. Abbott Architect
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
TDM & Instrument Platforms
Analyte* Instrument
Digoxin 1, 2
Acetaminophen 1, 2
Salicylate 1, 3
Carbamazepine 1, 2
Phenytoin 1, 2
Valproic Acid 1, 2
Vancomycin 1, 2
1. Siemens Dimension RxL
2. Abbott Architect
3. OCD VITROS 5600
Analitos e instrumentos: Fármacos y serología
IFD Analytes & Instrument Platforms
Analyte Instrument
Anti-HIV-1& 2 1, 4
Hepatitis B Surface Ag 2 ,3
Anti-HBs 2, 3
Anti-Hepatitis B core 2, 3
anti-Hepatitis C Virus 1, 2
Syphilis 3, 5
HIV-Ag/Ab Combo 2
1. Ortho Vitros 3600 2. Abbott Architect
3. Siemens Immulite 2000 4. HIV Rapid Test
5. ASI RPR Card Test
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
1 BD White Paper VS 9173: Comparison of the BD Vacutainer® Barricor™ Tube with the BD Vacutainer® PST™ II Tube for Selected Routine Chemistry Analytes on the Roche Modular, 2016
2 BD White Paper VS 9175: Comparison of the BD Vacutainer® Barricor™ Tube with the BD Vacutainer® PST™ II Tube for Selected Routine Chemistry Analytes on the Beckman Coulter AU680 and Immunoassays on the Beckman Coulter UniCel® DxI, 2016
3 BD White Paper VS 9188, Comparison of the BD Vacutainer® Barricor™ Tube with the BD Vacutainer® PST™ II Tube for Selected Cardiac Markers on the Siemens Dimension, Beckman Coulter Access® 2, Roche cobas e411 and Siemens ADVIA Centaur®, 2016
4 BD White Paper VS 9190, Comparison of the BD Vacutainer® Barricor™ Tube with the BD Vacutainer® PST™ II Tube for Selected Special Chemistry Analytes on the multiple instruments, 2016
5 BD White Paper VS 9194, Comparison of the BD Vacutainer® Barricor™ Tube with the BD Vacutainer® SST™ II Advance Tube for Selected Routine Chemistry Analytes on the Roche Modular, 2016
6 BD White Paper VS9198, Comparison of the BD Vacutainer® Barricor™ Tube with the BD Vacutainer® SST™ II Advance Tube for Selected Routine Chemistry Analytes on the Beckman Coulter AU680 and Immunoassays on the Beckman Coulter UniCel® DxI, 2016
7 BD White Paper VS9200, Comparison of the BD Vacutainer® Barricor™ Tube with the BD Vacutainer® SST™ II Advance Tube for Selected Cardiac Markers on the Siemens Dimension, Beckman Coulter Access® 2, Roche cobas e411 and Siemens ADVIA Centaur®, 2016
8 BD White Paper VS 9202, Comparison of the BD Vacutainer® Barricor™ Tube with the BD Vacutainer® SST™ II Advance Tube for Selected Special Chemistry Analytes, 2016
9 BD White Paper VS9295, Within-Tube Stability of Selected Routine Chemistry Analytes and Immunoassays in BD Vacutainer® Barricor™ Tubes in Comparison with BD Vacutainer® PST™ II and SST™ II Advance Tubes at Multiple Time Points Post Centrifugation, 2016
10 BD White Paper VS9168, Comparison of the BD Vacutainer® Barricor™ Tube with the BD Vacutainer® PST™ II Tube and BD Vacutainer® Serum Tube for Selected Therapeutic Drugs, 2016
11 BD White Paper VS9236, Comparison of BD Vacutainer® Barricor™ Tubes with BD Vacutainer® PST™ II, SST™ II and Serum Tubes for Selected Diagnostic Infectious Disease Marker Assays, 2016
12 Platform Expansion Study: Evaluation of Barricor™ vs PST™ II/SST™ II on the Abbott Architect Ci4100/i1000SR
13 BD White Paper VS9216, Comparison of the BD Vacutainer® Barricor™ Tube with the BD Vacutainer® PST™ II and BD Vacutainer® SST™ II Advance Tubes for
Selected Routine Chemistry Analytes and Immunoassays on the Siemens ADVIA® 1800, 2016
14 Platform Expansion Study: Evaluation of Barricor™ vs PST™ II/SST™ II on the Siemens Dimension ExL
15 Platform Expansion Study: Evaluation of Barricor™ vs PST™ II/SST™ II on the Siemens Dimension Vista 1500
16 BD White Paper VS9242, Comparison of the BD Vacutainer® Barricor™ Tube With the BD Vacutainer® PST™ II Tube and BD Vacutainer® SST™ II Advance Tube for Selected Routine Chemistry Analytes and Immunoassays on the Roche cobas® 6000, 2016
18 BD White Paper VS9192, Evaluation of Analyte Performance (including cell count, plasma yield, visuals) at Various Centrifugation Conditions (optimum vs recommended), 2016
19 BD White Paper VS9243, BD Barricor™ Maintains Separator Position and Barrier Integrity When Used in Pneumatic Tube System, 2016
20 BD White Paper VS9191, BD Vacutainer® Barricor™ Tube Performance while freezing and thawing a Separated Blood Sample, 2016
21 VS9244 BD Barricor Temperature Excursion Technical Letter, 2016
22 BD White Paper VS9196, Within-Tube Stability of Selected Immunoassay Analytes in BD Vacutainer® Barricor™ Tubes in Comparison with BD Vacutainer® PST™ II and SST™ II Advance Tubes at Multiple Time Points Post Centrifugation on the Beckman Coulter DxI, 2016.
BD Barricor™ Resumen de White Papers Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
¿Qué ha sucedido desde Abril?
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
Actualización
Principales hitos:
• Obtención del marcado CE: Abril 2016
• El pasado 23 de Septiembre obtuvimos la autorización de la FDA
(FDA 510k clearance)
• Actualmente realizando distintas pruebas de validación en
rutina/urgencias y para poblaciones específicas de pacientes
(hemodiálisis, hospital de día, etc)
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
Más información:
• http://barricor.bd.com
• Specimencare.com
Actualización Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
Beneficios BD Vacutainer® Barricor™
* Claim not established data pending
Consolidación de tubos
• Fármacos
• Espectrometría masas
• Validado para Zinc
Ahorro en tiempos de
coagulación
• Reducción de 30 a 60 minutos
frente a tubos de suero
Centrifugación más rápida hasta
3 minutos
• Reducción de TAT
• Mejora del flujo y rendimiento de
centrifugación
Ausencia de problemas de fibrina frente a tubos de suero con gel
Potencial reducción de alicuotas
• Mejoría en la eficiencia
• Reducción de costes y probabilidad
de errores*
Separación sin gel
• Eliminación de artefactos por gel
• Reducción potencial en
mantenimientos no programados
por obstrucción de sondas en
equipos*
Mayor estabilidad frente a tubos de
plasma con gel por menor
contaminación celular
• Reducción potencial en ensayos
confirmatorios*
• Potencial mejora en ensayos de alta sensibilidad*
Congreso Nacional del Laboratorio Clínico 2016
Innovación en la Fase Preanalítica y experiencias de acreditación
20 de Octubre de 2016, Zaragoza
Congreso Nacional del Laboratorio Clínico 2016
UZ Leuven
• Inpeco Track coupled to 2 x Abbott Architect, 2 x Roche Modular and 2 x Roche Cobas
8000
• 4 centrifuges running at 2113 g for 10 min
• Current usage: BD SSTII - serology, BD PSTII - chemistry and IA, LiHep - TDM
• Validation Barricor:
– Barricor will replace the bulk BD PSTII, LiHep and BD SSTII samples
• Support with BD Barricor white papers and technical inserts Abbott/Roche
• BD Barricor 5.5 mL
– Implementation of improved centrifugation protocol: 3000g for 5 min
• Support with available white papers on BD PSTII , BD SSTII and external publication
from Dr Petermsmann*
– Protocol will include centrifugation and validation of these analytes on BD Barricor
* Optimizing centrifugation of coagulation samples in laboratory automation. Suchsland et al. Clin Chem Lab Med 2014; 52(8): 1187–1191
Congreso Nacional del Laboratorio Clínico 2016
Erasmus MC, Rotterdam
• Roche Cobas 8100 Total Lab Automation with 2 online centrifuges set at 3000 g for 5
mins
• Core chemistry test panel currently on BD SSTII (8.5 ml)
• All routine samples (serum, citrate, urine, ..) are centrifuged with this protocol
• Endocrinology lab has 1 centrifuge (2163 g for 10 minutes) and centrifuges all incoming
samples regardless whether they have been centrifuged before!
• Validation Barricor:
– Some endocrinology (thyroid panel) tests will move to core lab, this can be validated easily
with the available white papers.
– Centrifugation protocol in the core lab does not need any modification
– All biochemistry analytes will be converted to BD Barricor with the support of the available
White papers and product inserts from Roche
– 5.5 mL Barricor is not necessary but as they are coming from 8.5 ml BD SSTII this is more
comfortable
Congreso Nacional del Laboratorio Clínico 2016