γ antibody 1β antibody dawn stollar 02 mar 2017 …/media/files/coa/k00xxxxx...controls tested may...

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RFE MEMO Page 1 of 1 Memo Rev. A CM-00289-B Product Description(s): V-PLEX® and V-PLEX Plus Proinflammatory Panel 2 (rat) Kit Catalog Number(s) / Size(s): K15059-series Lot Number: K0080651 Based on additional testing, the original date of expiration for this kit has been extended by 12 months. The expiration date of K0080651 has been extended to 31 Jul 2018. The expiration dates for the following kit components have also been extended: Description Lot Number Original Expiration Date New Expiration Date Proinflammatory Panel 2 (rat) Plate Z0046287 30 Apr 2019 Same as Original Anti-rat IFN-γ Antibody D0080844 30 Apr 2019 Same as Original Anti-rat IL-1β Antibody D0080845 30 Apr 2019 Same as Original Anti-rat IL-4 Antibody D0080696 31 Jul 2018 Same as Original Anti-rat IL-5 Antibody D0080698 31 Jul 2018 Same as Original Anti-rat IL-6 Antibody D0080846 30 Apr 2019 Same as Original Anti-rat KC/GRO Antibody D0080847 30 Apr 2019 Same as Original Anti-rat IL-10 Antibody D0080848 30 Apr 2019 Same as Original Anti-rat IL-13 Antibody D0080671 30 Apr 2018 31 Jul 2018 Anti-rat TNF-α Antibody D0080849 30 Apr 2019 Same as Original Proinflammatory Panel 1 (rat) Calibrator Blend A0080083 31 May 2021 Same as Original Blocker H R0100010 28 Feb 2018 31 Jul 2018 Diluent 42 M0420008 28 Feb 2018 31 Jul 2018 Diluent 40 M0400009 31 Jul 2017 31 Jul 2018 Function Name Signature Date Quality Assurance This memo supersedes all other statements regarding date of expiration for this product. Dawn Stollar 02 MAR 2017

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RFE MEMO

Page 1 of 1

Memo Rev. A CM-00289-B

Product Description(s): V-PLEX® and V-PLEX Plus Proinflammatory Panel 2 (rat) Kit

Catalog Number(s) / Size(s): K15059-series

Lot Number: K0080651

Based on additional testing, the original date of expiration for this kit has been extended by 12 months.

The expiration date of K0080651 has been extended to 31 Jul 2018.

The expiration dates for the following kit components have also been extended:

Description Lot Number Original Expiration

Date

New Expiration

Date

Proinflammatory Panel 2 (rat) Plate Z0046287 30 Apr 2019 Same as Original

Anti-rat IFN-γ Antibody D0080844 30 Apr 2019 Same as Original

Anti-rat IL-1β Antibody D0080845 30 Apr 2019 Same as Original

Anti-rat IL-4 Antibody D0080696 31 Jul 2018 Same as Original

Anti-rat IL-5 Antibody D0080698 31 Jul 2018 Same as Original

Anti-rat IL-6 Antibody D0080846 30 Apr 2019 Same as Original

Anti-rat KC/GRO Antibody D0080847 30 Apr 2019 Same as Original

Anti-rat IL-10 Antibody D0080848 30 Apr 2019 Same as Original

Anti-rat IL-13 Antibody D0080671 30 Apr 2018 31 Jul 2018

Anti-rat TNF-α Antibody D0080849 30 Apr 2019 Same as Original

Proinflammatory Panel 1 (rat) Calibrator

Blend A0080083 31 May 2021 Same as Original

Blocker H R0100010 28 Feb 2018 31 Jul 2018

Diluent 42 M0420008 28 Feb 2018 31 Jul 2018

Diluent 40 M0400009 31 Jul 2017 31 Jul 2018

Function Name Signature Date

Quality Assurance

This memo supersedes all other statements regarding date of expiration for this product.

Dawn Stollar 02 MAR 2017

Acceptance Data/ Percent Recovery Specifications:

Calibrator Proinflammatory Panel 1 (rat) Control 1

Proinflammatory Panel 1 (rat) Control 2

Proinflammatory Panel 1 (rat) Control 3

Spot Name Recovery CV Recovery CV Recovery CV Recovery CV

1 rt IFN-γ 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

2 rt IL-1β 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

4 rt IL-4 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

5 rt IL-5 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

6 rt IL-6 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

7 rt KC/GRO 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

8 rt IL-10 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

9 rt IL-13 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

10 rt TNF-α 80% - 120% < 20% 75% - 125% < 25% 75% - 125% < 25% 75% - 125% < 25%

LLOQ ULOQ

Spot Name Value Recovery CV Value Recovery CV

1 rt IFN-γ 39.7 75% - 125% < 25% 3750 75% - 125% < 25%

2 rt IL-1β 102 75% - 125% < 25% 8100 75% - 125% < 25%

4 rt IL-4 8.00 75% - 125% < 25% 723 75% - 125% < 25%

5 rt IL-5 82.0 75% - 125% < 25% 3000 75% - 125% < 25%

6 rt IL-6 96.9 75% - 125% < 25% 8550 75% - 125% < 25%

7 rt KC/GRO 21.7 75% - 125% < 25% 728 75% - 125% < 25%

8 rt IL-10 163 75% - 125% < 25% 15700 75% - 125% < 25%

9 rt IL-13 12.5 75% - 125% < 25% 1080 75% - 125% < 25%

10 rt TNF-α 9.10 75% - 125% < 25% 793 75% - 125% < 25%

Product Description: V-PLEX® and V-PLEX Plus Proinflammatory Panel 2 (rat) Kit

Kit Catalog Numbers: K15059-Series

Kit Lot Number: K0080651

Expiration Date: 31 Jul 2017

COA-7590-A485-640

CERTIFICATE OF ANALYSIS

Page 1 of 5

Stock Concentration of Material Tested : Spot Name Item Conc Units

1 rt IFN-γ

Calibrator 6300 pg/mL

Proinflammatory Panel 1 (rat) Control 1 4313 pg/mL

Proinflammatory Panel 1 (rat) Control 2 1049 pg/mL

Proinflammatory Panel 1 (rat) Control 3 517 pg/mL

2 rt IL-1β

Calibrator 13700 pg/mL

Proinflammatory Panel 1 (rat) Control 1 12400 pg/mL

Proinflammatory Panel 1 (rat) Control 2 7940 pg/mL

Proinflammatory Panel 1 (rat) Control 3 1820 pg/mL

4 rt IL-4

Calibrator 1310 pg/mL

Proinflammatory Panel 1 (rat) Control 1 951 pg/mL

Proinflammatory Panel 1 (rat) Control 2 312 pg/mL

Proinflammatory Panel 1 (rat) Control 3 81.5 pg/mL

5 rt IL-5

Calibrator 9280 pg/mL

Proinflammatory Panel 1 (rat) Control 1 3380 pg/mL

Proinflammatory Panel 1 (rat) Control 2 1730 pg/mL

Proinflammatory Panel 1 (rat) Control 3 770 pg/mL

6 rt IL-6

Calibrator 12200 pg/mL

Proinflammatory Panel 1 (rat) Control 1 4783 pg/mL

Proinflammatory Panel 1 (rat) Control 2 1807 pg/mL

Proinflammatory Panel 1 (rat) Control 3 434 pg/mL

7 rt KC/GRO Calibrator 4060 pg/mL

Acceptance Data/ Non Specific Binding Specifications:

Spot Name NSB Spec

1 rt IFN-γ < 1.0%

2 rt IL-1β < 1.0%

4 rt IL-4 < 1.0%

5 rt IL-5 < 1.0%

6 rt IL-6 < 1.0%

7 rt KC/GRO < 1.0%

8 rt IL-10 < 1.0%

9 rt IL-13 < 1.0%

10 rt TNF-α < 1.0%

COA-7590-A485-640

CERTIFICATE OF ANALYSIS

Page 2 of 5

Controls tested may not be the same lot as shipped.

7 rt KC/GRO

Proinflammatory Panel 1 (rat) Control 1 554 pg/mL

Proinflammatory Panel 1 (rat) Control 2 327 pg/mL

Proinflammatory Panel 1 (rat) Control 3 158 pg/mL

8 rt IL-10

Calibrator 26100 pg/mL

Proinflammatory Panel 1 (rat) Control 1 19800 pg/mL

Proinflammatory Panel 1 (rat) Control 2 4360 pg/mL

Proinflammatory Panel 1 (rat) Control 3 1640 pg/mL

9 rt IL-13

Calibrator 1670 pg/mL

Proinflammatory Panel 1 (rat) Control 1 1580 pg/mL

Proinflammatory Panel 1 (rat) Control 2 495 pg/mL

Proinflammatory Panel 1 (rat) Control 3 162 pg/mL

10 rt TNF-α

Calibrator 1340 pg/mL

Proinflammatory Panel 1 (rat) Control 1 803 pg/mL

Proinflammatory Panel 1 (rat) Control 2 282 pg/mL

Proinflammatory Panel 1 (rat) Control 3 86.9 pg/mL

COA-7590-A485-640

CERTIFICATE OF ANALYSIS

Page 3 of 5

Standard Curve Data:

Conc.pg/mL

ECLSignal

%CV

6300 1,530,000 3.9

1580 425,000 7.2

394 90,100 6.3

98.4 24,200 8.7

24.6 5,680 4.3

6.15 1,940 5.9

1.54 796 5.2

0.00 474 6.8

rt IFN-γ - Spot 1

Conc.pg/mL

ECLSignal

%CV

13700 1,220,000 2.6

3430 220,000 3.1

856 37,600 2.7

214 8,000 2.4

53.5 2,200 2.5

13.4 752 4.3

3.34 413 5.2

0.00 276 5.8

rt IL-1β - Spot 2

Conc.pg/mL

ECLSignal

%CV

1310 1,110,000 2.4

328 302,000 1.9

81.9 57,900 1.6

20.5 11,500 1.4

5.12 2,750 3.2

1.28 955 3.5

0.320 511 6.6

0.00 352 5.8

rt IL-4 - Spot 4

Conc.pg/mL

ECLSignal

%CV

9280 1,610,000 3.2

2320 491,000 2.6

580 83,700 5.2

145 10,200 3.5

36.3 1,440 3.5

9.06 492 5.3

2.27 376 5.3

0.00 334 5.4

rt IL-5 - Spot 5

Conc.pg/mL

ECLSignal

%CV

12200 299,000 2.5

3050 62,700 2.4

763 14,000 3.5

191 3,410 2.4

47.7 1,190 5.1

11.9 560 7.1

2.98 413 8.3

0.00 371 14.0

rt IL-6 - Spot 6

Conc.pg/mL

ECLSignal

%CV

4060 1,120,000 3.5

1020 544,000 2.2

254 133,000 2.4

63.4 29,100 4.3

15.9 8,260 3.4

3.96 2,800 3.4

0.991 1,400 8.8

0.00 1,030 11.0

rt KC/GRO - Spot 7

Conc.pg/mL

ECLSignal

%CV

26100 911,000 4.1

6530 245,000 3.3

1630 61,700 3.6

408 16,100 4.7

102 4,340 3.8

25.5 1,640 12.0

6.37 877 11.0

0.00 737 20.0

rt IL-10 - Spot 8

Conc.pg/mL

ECLSignal

%CV

1670 1,150,000 2.1

418 212,000 2.2

104 33,600 2.4

26.1 6,190 2.2

6.52 1,730 5.7

1.63 688 15.0

0.408 448 11.0

0.00 416 20.0

rt IL-13 - Spot 9

Conc.pg/mL

ECLSignal

%CV

1340 923,000 3.5

335 209,000 2.4

83.8 42,700 2.0

20.9 9,740 2.3

5.23 3,120 5.1

1.31 1,240 10.0

0.327 987 16.0

0.00 762 18.0

rt TNF-α - Spot 10

COA-7590-A485-640

CERTIFICATE OF ANALYSIS

Page 4 of 5

Name Function Signature Date

Review/Approval Quality Assurance

Components:

Description Lot Number Storage Temperature Expiration Date

Proinflammatory Panel 2 (rat) Plate Z0046287 2-8°C 30 Apr 2019

Anti-rat IFN-γ Antibody D0080844 2-8°C 31 Jul 2018

Anti-rat IL-1β Antibody D0080845 2-8°C 31 Jul 2018

Anti-rat IL-4 Antibody D0080696 2-8°C 31 Jul 2018

Anti-rat IL-5 Antibody D0080698 2-8°C 31 Jul 2018

Anti-rat IL-6 Antibody D0080846 2-8°C 30 Apr 2019

Anti-rat KC/GRO Antibody D0080847 2-8°C 30 Apr 2019

Anti-rat IL-10 Antibody D0080848 2-8°C 30 Apr 2019

Anti-rat IL-13 Antibody D0080671 2-8°C 30 Apr 2018

Anti-rat TNF-α Antibody D0080849 2-8°C 30 Apr 2019

Proinflammatory Panel 1 (rat) Calibrator Blend A0080083 2-8°C 31 May 2021

Blocker H R0100010 Room Temperature 28 Feb 2018

Diluent 42 M0420008 ≤ -10°C 28 Feb 2018

Diluent 40 M0400009 ≤ -10°C 31 Jul 2017

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

Proinflammatory Panel 1 (rat) Control 1 Not Kit Specific

Proinflammatory Panel 1 (rat) Control 2 Not Kit Specific

Proinflammatory Panel 1 (rat) Control 3 Not Kit Specific

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

Statement:

COA-7590-A485-640

CERTIFICATE OF ANALYSIS

Page 5 of 5

Dawn Stollar 02 MAR 2017