γ antibody 1β antibody dawn stollar 02 mar 2017 …/media/files/coa/k00xxxxx...controls tested may...
TRANSCRIPT
RFE MEMO
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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
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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
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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
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Dawn Stollar 02 MAR 2017