certificate of analysis/media/files/coa/k00xxxxx/k... · 2017. 5. 2. · certificate of analysis...

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CERTIFICATE OF ANALYSIS Page 1 of 4 COA-8146-A 731-744 Product Description: V-PLEX® and V-PLEX Plus Angiogenesis Panel 1 (human) Kit Kit Catalog Numbers: K15190-Series Kit Lot Number: K0080712 Expiration Date: 31 Dec 2018 Acceptance Data/ Percent Recovery Specifications: Calibrator Angiogenesis Control 1 Angiogenesis Control 2 Angiogenesis Control 3 Spot Name Recovery CV Recovery CV Recovery CV Recovery CV 1 hu VEGF 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25% 2 hu VEGF-C 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25% 3 hu VEGF-D 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25% 4 hu Tie-2 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25% 5 hu Flt-1 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25% 6 hu PlGF 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25% 7 hu bFGF 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25% LLOQ ULOQ Spot Name Value Recovery CV Value Recovery CV 1 hu VEGF 5.00 80% - 120% < 20% 1510 80% - 120% < 20% 2 hu VEGF-C 146 80% - 120% < 20% 17500 80% - 120% < 20% 3 hu VEGF-D 67.1 80% - 120% < 20% 18800 80% - 120% < 20% 4 hu Tie-2 396 80% - 120% < 20% 63400 80% - 120% < 20% 5 hu Flt-1 10.0 80% - 120% < 25% 6410 80% - 120% < 20% 6 hu PlGF 1.50 80% - 120% < 25% 800 80% - 120% < 25% 7 hu bFGF 2.60 80% - 120% < 25% 1780 80% - 120% < 20% Acceptance Data/ Non Specific Binding Specifications: Spot Name hu VEGF hu VEGF-C hu VEGF-D hu Tie-2 hu Flt-1 1 hu VEGF NA < 0.5% < 0.5% < 0.5% < 10.0% 2 hu VEGF-C < 0.5% NA < 0.5% < 0.5% < 0.5% 3 hu VEGF-D < 0.5% < 5.0% NA < 0.5% < 0.5% 4 hu Tie-2 < 0.5% < 0.5% < 0.5% NA < 0.5% 5 hu Flt-1 < 10.0% < 5.0% < 0.5% < 0.5% NA 6 hu PlGF < 0.5% < 0.5% < 0.5% < 0.5% < 0.5% 7 hu bFGF < 0.5% < 0.5% < 0.5% < 0.5% < 0.5%

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Page 1: CERTIFICATE OF ANALYSIS/media/files/coa/k00xxxxx/k... · 2017. 5. 2. · CERTIFICATE OF ANALYSIS Page 1 of 4 COA-8146-A 731-744 Product Description: V-PLEX® and V-PLEX Plus Angiogenesis

CERTIFICATE OF ANALYSIS

Page 1 of 4

COA-8146-A 731-744

Product Description: V-PLEX® and V-PLEX Plus Angiogenesis Panel 1 (human) Kit

Kit Catalog Numbers: K15190-Series

Kit Lot Number: K0080712

Expiration Date: 31 Dec 2018

Acceptance Data/ Percent Recovery Specifications:

Calibrator Angiogenesis Control 1 Angiogenesis Control 2 Angiogenesis Control 3

Spot Name Recovery CV Recovery CV Recovery CV Recovery CV

1 hu VEGF 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

2 hu VEGF-C 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

3 hu VEGF-D 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

4 hu Tie-2 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

5 hu Flt-1 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

6 hu PlGF 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

7 hu bFGF 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

LLOQ ULOQ

Spot Name Value Recovery CV Value Recovery CV

1 hu VEGF 5.00 80% - 120% < 20% 1510 80% - 120% < 20%

2 hu VEGF-C 146 80% - 120% < 20% 17500 80% - 120% < 20%

3 hu VEGF-D 67.1 80% - 120% < 20% 18800 80% - 120% < 20%

4 hu Tie-2 396 80% - 120% < 20% 63400 80% - 120% < 20%

5 hu Flt-1 10.0 80% - 120% < 25% 6410 80% - 120% < 20%

6 hu PlGF 1.50 80% - 120% < 25% 800 80% - 120% < 25%

7 hu bFGF 2.60 80% - 120% < 25% 1780 80% - 120% < 20%

Acceptance Data/ Non Specific Binding Specifications:

Spot Name hu VEGF hu VEGF-C hu VEGF-D hu Tie-2 hu Flt-1

1 hu VEGF NA < 0.5% < 0.5% < 0.5% < 10.0%

2 hu VEGF-C < 0.5% NA < 0.5% < 0.5% < 0.5%

3 hu VEGF-D < 0.5% < 5.0% NA < 0.5% < 0.5%

4 hu Tie-2 < 0.5% < 0.5% < 0.5% NA < 0.5%

5 hu Flt-1 < 10.0% < 5.0% < 0.5% < 0.5% NA

6 hu PlGF < 0.5% < 0.5% < 0.5% < 0.5% < 0.5%

7 hu bFGF < 0.5% < 0.5% < 0.5% < 0.5% < 0.5%

Page 2: CERTIFICATE OF ANALYSIS/media/files/coa/k00xxxxx/k... · 2017. 5. 2. · CERTIFICATE OF ANALYSIS Page 1 of 4 COA-8146-A 731-744 Product Description: V-PLEX® and V-PLEX Plus Angiogenesis

CERTIFICATE OF ANALYSIS

Page 2 of 4

COA-8146-A 731-744

Spot Name hu PlGF hu bFGF

1 hu VEGF < 0.5% < 0.5%

2 hu VEGF-C < 0.5% < 0.5%

3 hu VEGF-D < 0.5% < 0.5%

4 hu Tie-2 < 0.5% < 0.5%

5 hu Flt-1 < 0.5% < 0.5%

6 hu PlGF NA < 0.5%

7 hu bFGF < 0.5% NA

Stock Concentration of Material Tested :

Spot Name Item Conc Units

1 hu VEGF

20X Calibrator 35000 pg/mL

Angiogenesis Control 1 1440 pg/mL

Angiogenesis Control 2 125 pg/mL

Angiogenesis Control 3 17 pg/mL

2 hu VEGF-C

20X Calibrator 436000 pg/mL

Angiogenesis Control 1 22400 pg/mL

Angiogenesis Control 2 3010 pg/mL

Angiogenesis Control 3 596 pg/mL

3 hu VEGF-D

20X Calibrator 484000 pg/mL

Angiogenesis Control 1 22300 pg/mL

Angiogenesis Control 2 3320 pg/mL

Angiogenesis Control 3 655 pg/mL

4 hu Tie-2

20X Calibrator 1648000 pg/mL

Angiogenesis Control 1 67600 pg/mL

Angiogenesis Control 2 10400 pg/mL

Angiogenesis Control 3 1680 pg/mL

5 hu Flt-1

20X Calibrator 165000 pg/mL

Angiogenesis Control 1 6510 pg/mL

Angiogenesis Control 2 549 pg/mL

Angiogenesis Control 3 67.4 pg/mL

6 hu PlGF

20X Calibrator 24400 pg/mL

Angiogenesis Control 1 1950 pg/mL

Angiogenesis Control 2 203 pg/mL

Angiogenesis Control 3 20.7 pg/mL

7 hu bFGF

20X Calibrator 39200 pg/mL

Angiogenesis Control 1 1470 pg/mL

Angiogenesis Control 2 134 pg/mL

Angiogenesis Control 3 16.9 pg/mL

Controls tested may not be the same lot as shipped.

Concentrations provided in this table refer to the stock concentration of the calibrators. For top of the standard curve concentrations, please refer to the Standard Curve Data

Page 3: CERTIFICATE OF ANALYSIS/media/files/coa/k00xxxxx/k... · 2017. 5. 2. · CERTIFICATE OF ANALYSIS Page 1 of 4 COA-8146-A 731-744 Product Description: V-PLEX® and V-PLEX Plus Angiogenesis

CERTIFICATE OF ANALYSIS

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COA-8146-A 731-744

Standard Curve Data:

hu VEGF - Spot 1

Conc. pg/mL

ECL Signal

%CV

1750 554,000 2.1

438 101,000 2.7

109 20,700 2.8

27.3 4,870 2.3

6.84 1,380 4.1

1.71 487 6.6

0.427 262 8.0

0.00 216 23.0

hu VEGF-C - Spot 2

Conc. pg/mL

ECL Signal

%CV

21800 430,000 5.8

5450 73,000 6.0

1360 13,600 3.3

341 3,080 5.9

85.2 952 3.7

21.3 414 3.4

5.32 281 4.6

0.00 235 4.0

hu VEGF-D - Spot 3

Conc. pg/mL

ECL Signal

%CV

24200 651,000 5.2

6050 198,000 3.6

1510 42,100 4.3

378 8,380 5.5

94.5 1,990 7.5

23.6 656 6.8

5.91 299 7.4

0.00 364 32.0

hu Tie-2 - Spot 4

Conc. pg/mL

ECL Signal

%CV

82400 136,000 3.3

20600 31,400 2.4

5150 7,840 3.5

1290 2,120 5.3

322 680 6.3

80.5 341 8.2

20.1 244 7.0

0.00 223 8.8

hu Flt-1 - Spot 5

Conc. pg/mL

ECL Signal

%CV

8250 354,000 1.7

2060 91,100 2.6

516 23,100 2.5

129 5,770 3.0

32.2 1,580 2.5

8.06 488 3.4

2.01 231 5.5

0.00 136 8.0

hu PlGF - Spot 6

Conc. pg/mL

ECL Signal

%CV

1220 826,000 3.7

305 208,000 3.1

76.3 48,900 2.5

19.1 12,000 2.4

4.77 3,270 3.5

1.19 1,080 6.6

0.298 532 11.0

0.00 350 16.0

hu bFGF - Spot 7

Conc. pg/mL

ECL Signal

%CV

1960 799,000 4.2

490 218,000 3.0

123 55,400 3.2

30.6 13,700 4.8

7.66 3,680 6.3

1.91 1,050 3.5

0.479 389 3.8

0.00 156 11.0

Page 4: CERTIFICATE OF ANALYSIS/media/files/coa/k00xxxxx/k... · 2017. 5. 2. · CERTIFICATE OF ANALYSIS Page 1 of 4 COA-8146-A 731-744 Product Description: V-PLEX® and V-PLEX Plus Angiogenesis

CERTIFICATE OF ANALYSIS

Page 4 of 4

COA-8146-A 731-744

Components:

Description Lot Number Storage Temperature Expiration Date

Angiogenesis Panel 1 (human) Plate Z0055823 2-8°C 31 Jul 2019

Anti-hu VEGF Antibody D0080782 2-8°C 31 Mar 2019

Anti-hu VEGF-C Antibody D0080783 2-8°C 31 Mar 2019

Anti-hu VEGF-D Antibody D0080777 2-8°C 31 Mar 2019

Anti-hu Tie-2 Antibody D0080778 2-8°C 31 Mar 2019

Anti-hu Flt-1 Antibody D0080779 2-8°C 31 Mar 2019

Anti-hu PlGF Antibody D0080910 2-8°C 31 Aug 2019

Anti-hu bFGF Antibody D0080781 2-8°C 31 Mar 2019

Angiogenesis Panel 1 (human) Calibrator Blend A0080078 ≤ -70°C 31 Dec 2018

MSD Blocker A Not Kit Specific Not Kit Specific N/A

Diluent 7 M0070051 ≤ -10°C 31 Mar 2019

Diluent 11 M0110029 ≤ -10°C 31 Dec 2018

MSD Phosphate Buffer (5X) Not Kit Specific Not Kit Specific N/A

MSD Read Buffer T Not Kit Specific Not Kit Specific N/A

Additional Components Included in V-PLEX Plus

Plate Seals Not Kit Specific

Wash Buffer (20X), 100mL Not Kit Specific

Angiogenesis Control 1 Not Kit Specific

Angiogenesis Control 2 Not Kit Specific

Angiogenesis Control 3 Not Kit Specific

Statement:

The above product is intended for Research Use Only. Not for use in Diagnostic Procedures.

Name Function Signature Date

Review/Approval Dawn Stollar Quality Assurance

18 APR 2017