innovación en fase preanalítica -...

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



¿Dónde innovar?




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.




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



¿Como reducir el TAT?

Acelerar Fase Analítica

Reducir el tiempo de procesado de muestras

Acelerar el transporte de muestras

Uso de plasma




Uso de suero o plasma

‘Analizando los mitos del plasma’




Balance de beneficios

Pureza TAT




Suero Plasma

Suero o plasma Congreso Nacional del Laboratorio Clínico 2016



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




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)




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




¿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



7 de Abril de 2016, Madrid




BD Vacutainer® Barricor™ Plasma Congreso Nacional del Laboratorio Clínico 2016

BDARTFinal01.mp4



BD Vacutainer® Barricor™ Plasma Congreso Nacional del Laboratorio Clínico 2016



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




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.




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 %




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




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




Validación

BD Vacutainer® Barricor™




¿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



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



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


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


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


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


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


5/18/2015

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


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




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




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




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



¿Qué ha sucedido desde Abril?




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)




Más información:

• http://barricor.bd.com

• Specimencare.com

Actualización Congreso Nacional del Laboratorio Clínico 2016

http://barricor.bd.com/



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*




[email protected]


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


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


innovación en fase preanalítica -...

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