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CERTIFICATE OF ANALYSIS COA-06397 Page 1 of 5 Product Description: V-PLEX® and V-PLEX Plus Proinflammatory Panel 1 (human) Kit Kit Catalog Numbers: K15049D-1, K15049D-2, K15049D-4, K15049G-1, K15049G-2, K15049G-4 Kit Lot Number: K0080497 Expiration Date: 30 Sep 2017 Acceptance Data/ Percent Recovery Specifications: Calibrator Proinflammatory Panel 1 (human) Control 1 Proinflammatory Panel 1 (human) Control 2 Proinflammatory Panel 1 (human) Control 3 Spot Name Recovery CV Recovery CV Recovery CV Recovery CV 1 hu IFN-γ 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 2 hu IL-80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 3 hu IL-2 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 4 hu IL-4 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 5 hu IL-6 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 6 hu IL-8 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 7 hu IL-10 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 8 hu IL-12p70 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 9 hu IL-13 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 10 hu TNF-α 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% LLOQ ULOQ Spot Name Value Recovery CV Value Recovery CV 1 hu IFN-γ 7.47 80% - 120% < 20% 938 80% - 120% < 20% 2 hu IL-2.14 80% - 120% < 20% 375 80% - 120% < 20% 3 hu IL-2 0.890 80% - 120% < 20% 938 80% - 120% < 20% 4 hu IL-4 0.450 80% - 120% < 20% 158 80% - 120% < 20% 5 hu IL-6 1.58 80% - 120% < 20% 488 80% - 120% < 20% 6 hu IL-8 1.13 80% - 120% < 20% 375 80% - 120% < 20% 7 hu IL-10 0.680 80% - 120% < 20% 233 80% - 120% < 20% 8 hu IL-12p70 1.22 80% - 120% < 20% 315 80% - 120% < 20% 9 hu IL-13 4.21 80% - 120% < 20% 353 80% - 120% < 20% 10 hu TNF-α 0.690 80% - 120% < 20% 248 80% - 120% < 20%

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Page 1: CERTIFICATE OF ANALYSIS/media/files/coa/k00xxxxx/k008...CERTIFICATE OF ANALYSIS COA-06397 Page 3 of 5 8 hu IL-12p70 Calibrator 425 pg/mL Proinflammatory Panel 1 (human) Control 1 143

CERTIFICATE OF ANALYSIS

COA-06397

Page 1 of 5

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

Kit Catalog Numbers: K15049D-1, K15049D-2, K15049D-4, K15049G-1, K15049G-2, K15049G-4

Kit Lot Number: K0080497

Expiration Date: 30 Sep 2017

Acceptance Data/ Percent Recovery Specifications:

Calibrator Proinflammatory Panel 1

(human) Control 1 Proinflammatory Panel 1

(human) Control 2 Proinflammatory Panel 1

(human) Control 3

Spot Name Recovery CV Recovery CV Recovery CV Recovery CV

1 hu IFN-γ 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20%

2 hu IL-1β 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20%

3 hu IL-2 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20%

4 hu IL-4 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20%

5 hu IL-6 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20%

6 hu IL-8 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20%

7 hu IL-10 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20%

8 hu IL-12p70 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20%

9 hu IL-13 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20%

10 hu TNF-α 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20%

LLOQ ULOQ

Spot Name Value Recovery CV Value Recovery CV

1 hu IFN-γ 7.47 80% - 120% < 20% 938 80% - 120% < 20%

2 hu IL-1β 2.14 80% - 120% < 20% 375 80% - 120% < 20%

3 hu IL-2 0.890 80% - 120% < 20% 938 80% - 120% < 20%

4 hu IL-4 0.450 80% - 120% < 20% 158 80% - 120% < 20%

5 hu IL-6 1.58 80% - 120% < 20% 488 80% - 120% < 20%

6 hu IL-8 1.13 80% - 120% < 20% 375 80% - 120% < 20%

7 hu IL-10 0.680 80% - 120% < 20% 233 80% - 120% < 20%

8 hu IL-12p70 1.22 80% - 120% < 20% 315 80% - 120% < 20%

9 hu IL-13 4.21 80% - 120% < 20% 353 80% - 120% < 20%

10 hu TNF-α 0.690 80% - 120% < 20% 248 80% - 120% < 20%

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CERTIFICATE OF ANALYSIS

COA-06397

Page 2 of 5

Acceptance Data/ Non Specific Binding Specifications:

Spot Name NSB Spec

1 hu IFN-γ < 1.0%

2 hu IL-1β < 1.0%

3 hu IL-2 < 1.0%

4 hu IL-4 < 1.0%

5 hu IL-6 < 1.0%

6 hu IL-8 < 1.0%

7 hu IL-10 < 1.0%

8 hu IL-12p70 < 1.0%

9 hu IL-13 < 1.0%

10 hu TNF-α < 1.0%

Stock Concentration of Material Tested :

Spot Name Item Conc Units

1 hu IFN-γ

Calibrator 1500 pg/mL

Proinflammatory Panel 1 (human) Control 1 535 pg/mL

Proinflammatory Panel 1 (human) Control 2 140 pg/mL

Proinflammatory Panel 1 (human) Control 3 91.5 pg/mL

2 hu IL-1β

Calibrator 496 pg/mL

Proinflammatory Panel 1 (human) Control 1 199 pg/mL

Proinflammatory Panel 1 (human) Control 2 47.1 pg/mL

Proinflammatory Panel 1 (human) Control 3 15.1 pg/mL

3 hu IL-2

Calibrator 1380 pg/mL

Proinflammatory Panel 1 (human) Control 1 390 pg/mL

Proinflammatory Panel 1 (human) Control 2 37.0 pg/mL

Proinflammatory Panel 1 (human) Control 3 18.4 pg/mL

4 hu IL-4

Calibrator 262 pg/mL

Proinflammatory Panel 1 (human) Control 1 70.3 pg/mL

Proinflammatory Panel 1 (human) Control 2 15.0 pg/mL

Proinflammatory Panel 1 (human) Control 3 3.41 pg/mL

5 hu IL-6

Calibrator 653 pg/mL

Proinflammatory Panel 1 (human) Control 1 276 pg/mL

Proinflammatory Panel 1 (human) Control 2 53.6 pg/mL

Proinflammatory Panel 1 (human) Control 3 22.9 pg/mL

6 hu IL-8

Calibrator 575 pg/mL

Proinflammatory Panel 1 (human) Control 1 180 pg/mL

Proinflammatory Panel 1 (human) Control 2 28.3 pg/mL

Proinflammatory Panel 1 (human) Control 3 10.3 pg/mL

7 hu IL-10

Calibrator 312 pg/mL

Proinflammatory Panel 1 (human) Control 1 174 pg/mL

Proinflammatory Panel 1 (human) Control 2 26.1 pg/mL

Proinflammatory Panel 1 (human) Control 3 7.67 pg/mL

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8 hu IL-12p70

Calibrator 425 pg/mL

Proinflammatory Panel 1 (human) Control 1 143 pg/mL

Proinflammatory Panel 1 (human) Control 2 28.0 pg/mL

Proinflammatory Panel 1 (human) Control 3 7.32 pg/mL

9 hu IL-13

Calibrator 539 pg/mL

Proinflammatory Panel 1 (human) Control 1 209 pg/mL

Proinflammatory Panel 1 (human) Control 2 54.6 pg/mL

Proinflammatory Panel 1 (human) Control 3 44.4 pg/mL

10 hu TNF-α

Calibrator 327 pg/mL

Proinflammatory Panel 1 (human) Control 1 54.0 pg/mL

Proinflammatory Panel 1 (human) Control 2 12.4 pg/mL

Proinflammatory Panel 1 (human) Control 3 3.50 pg/mL

Controls tested may not be the same lot as shipped.

Standard Curve Data:

hu IFN-γ - Spot 1

Conc. pg/mL

ECL Signal

%CV

1500 319,000 1.1

375 89,400 1.6

93.8 22,900 3.0

23.4 5,920 2.4

5.86 1,630 2.1

1.46 639 4.6

0.366 364 6.0

0.00 278 7.2

hu IL-1β - Spot 2

Conc. pg/mL

ECL Signal

%CV

496 1,270,000 1.5

124 328,000 2.2

31.0 84,900 2.4

7.75 21,300 2.4

1.94 6,150 3.0

0.484 2,610 3.3

0.121 1,780 5.8

0.00 1,420 6.2

hu IL-2 - Spot 3

Conc. pg/mL

ECL Signal

%CV

1380 1,120,000 1.6

345 335,000 1.5

86.3 93,800 2.4

21.6 24,100 2.7

5.39 6,070 3.2

1.35 1,720 2.8

0.337 596 4.2

0.00 208 8.6

hu IL-4 - Spot 4

Conc. pg/mL

ECL Signal

%CV

262 862,000 1.8

65.5 276,000 2.4

16.4 78,000 3.5

4.09 20,500 3.3

1.02 5,260 3.0

0.256 1,680 3.3

0.0640 715 4.5

0.00 388 7.6

hu IL-6 - Spot 5

Conc. pg/mL

ECL Signal

%CV

653 1,190,000 3.2

163 304,000 2.2

40.8 69,400 3.4

10.2 16,400 2.6

2.55 4,030 3.4

0.638 1,190 3.8

0.159 436 3.8

0.00 172 7.7

hu IL-8 - Spot 6

Conc. pg/mL

ECL Signal

%CV

575 522,000 1.8

144 142,000 2.4

35.9 36,700 2.5

8.98 9,270 1.9

2.25 2,400 2.6

0.562 762 3.0

0.140 334 6.6

0.00 195 7.9

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CERTIFICATE OF ANALYSIS

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hu IL-10 - Spot 7

Conc. pg/mL

ECL Signal

%CV

312 522,000 1.5

78.0 152,000 1.5

19.5 40,500 1.7

4.88 10,100 1.2

1.22 2,670 2.2

0.305 839 3.0

0.0762 375 8.4

0.00 231 11.0

hu IL-12p70 - Spot 8

Conc. pg/mL

ECL Signal

%CV

425 248,000 3.8

106 76,400 3.6

26.6 20,800 3.0

6.64 5,380 3.2

1.66 1,430 3.5

0.415 507 4.7

0.104 282 7.2

0.00 194 17.0

hu IL-13 - Spot 9

Conc. pg/mL

ECL Signal

%CV

539 1,090,000 2.0

135 207,000 1.4

33.7 31,300 1.6

8.42 5,040 2.9

2.11 1,240 2.9

0.526 408 6.9

0.132 206 6.6

0.00 141 11.0

hu TNF-α - Spot 10

Conc. pg/mL

ECL Signal

%CV

327 331,000 2.3

81.8 85,700 1.5

20.4 21,800 2.6

5.11 5,380 3.1

1.28 1,540 2.5

0.319 588 7.4

0.0798 360 12.0

0.00 266 18.0

Components:

Description Lot Number Storage Temperature Expiration Date

Proinflammatory Panel 1 (human) Plate Z0045878 2-8°C 28 Feb 2018

Anti-hu IFN-γ Antibody D0080663 2-8°C 30 Apr 2018

Anti-hu IL-1β Antibody D0080614 2-8°C 31 Jan 2018

Anti-hu IL-2 Antibody D0080615 2-8°C 31 Jan 2018

Anti-hu IL-4 Antibody D0080565 2-8°C 30 Sep 2017

Anti-hu IL-6 Antibody D0080612 2-8°C 31 Jan 2018

Anti-hu IL-8 Antibody D0080613 2-8°C 31 Jan 2018

Anti-hu IL-10 Antibody D0080680 2-8°C 31 May 2018

Anti-hu IL-12p70 Antibody D0080567 2-8°C 30 Sep 2017

Anti-hu IL-13 Antibody D0080568 2-8°C 30 Sep 2017

Anti-hu TNF-α Antibody D0080679 2-8°C 31 May 2018

Proinflammatory Panel 1 (human) Calibrator Blend A0080070 2-8°C 30 Sep 2020

Diluent 2 M0020089 ≤ -10°C 31 Dec 2017

Diluent 3 M0030068 ≤ -10°C 28 Feb 2018

MSD Read Buffer T (4X) Not Kit Specific Not Kit Specific N/A

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CERTIFICATE OF ANALYSIS

COA-06397

Page 5 of 5

Additional Components Included in V-PLEX Plus

Plate Seals Not Kit Specific

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

Proinflammatory Panel 1 (human) Control 1 Not Kit Specific

Proinflammatory Panel 1 (human) Control 2 Not Kit Specific

Proinflammatory Panel 1 (human) Control 3 Not Kit Specific

Statement:

The above kit was tested using MSD procedures and it conforms to MSD's specifications. The above product is intended for

Research Use Only. Not for use in Diagnostic Procedures.

Name Function Signature Date

Review/Approval Quality Assurance

Dawn Stollar 18JAN2016