original evaluation bnp5-c 2015 b-type natriuretic ... · original evaluation bnp5-c 2015 b-type...

EVALUATIONORIGINAL

BNP5-C 2015 B-type Natriuretic Peptides, 5 Chal

INSTITUTION:

ATTENTION:

CAP NUMBER:

Laboratorio Medico Las AmericasMedellin ANT CO 050034

KIT INFORMATION:12/11/201510/27/2015

Original Evaluation:

Kit#7181660-01 1

Kit Mailed:28530787 Kit ID:

Ana Velasquez

Next Mailing Date:

2/23/2016

COPIED TO: LAP CAP

LEGEND: Exception Reason Codes appearing in this evaluation:<NONE>

Reviewed By Date

0001

The College of American Pathologists recommends that the result of this interlaboratory comparison not be used as a sole criterion for judging the performance of any individual clinical laboratory.

of 2

Evaluation and Comparative Method Statistics

Specimen Mean

YourResult S.D.

No. ofLabs LowerS.D.I Upper

YourGrade

Limits of Acceptability

BNP-11 61 66.1 5.8 450 -0.9 48 84 AcceptableBNP-12 1761 1877.5 111.0 444 -1.0 1544 2211 AcceptableBNP-13 134 140.8 9.9 389 -0.7 111 171 AcceptableBNP-14 460 475.4 35.3 391 -0.4 369 582 AcceptableBNP-15 26 27.2 2.3 387 -0.5 20 35 Acceptable

TestUnit of Measure

Peer Group

BNPpg/mL (ng/L)

ABBOTT ARCHITECT i

Plot of the Relative Distance of Your Results from Target as Percentages of allowed Deviation

Survey -100------------Mean-----------+100

BNP5-C 2015

BNP5-B 2015

0001


of 2

CAP Number:Institution:

Attention:City / State:

Laboratorio Medico Las AmericasAna VelasquezMedellin ANT CO 050034

7181660-01 Kit# 1 Kit ID: Kit Mailed:


28530787

10/27/2015

12/11/2015

BNP5-C 2015 B-type Natriuretic Peptides, 5 ChalE V A L U A T I O N

ORIGINAL

EVALUATIONORIGINAL

K-C 2015 Ligand Assay - General

INSTITUTION:

ATTENTION:

CAP NUMBER:


KIT INFORMATION:12/11/201511/9/2015


Kit#7181660-01 1


Ana Velasquez

Next Mailing Date:

4/4/2016

COPIED TO: LAP CAP

LEGEND: Exception Reason Codes appearing in this evaluation:[20] = No appropriate target/response cannot be graded.

Reviewed By Date

0001


Page 1 of 7


Specimen Mean

YourResult S.D.


YourGrade


K-11 13.9 13.67 0.71 32 +0.3 11.5 15.9 AcceptableK-12 43.9 42.84 2.50 32 +0.4 35.3 50.4 AcceptableK-13 117.6 115.25 7.60 32 +0.3 92.4 138.1 AcceptableK-14 48.1 45.99 3.23 33 +0.7 36.3 55.7 AcceptableK-15 48.2 46.03 2.45 33 +0.9 38.6 53.4 Acceptable

TestUnit of Measure

Peer Group

Alpha-Fetoproteinng/mL (ug/L)

BECKMAN ACCESS/2


Survey -100------------Mean-----------+100

K-C 2015

K-B 2015

K-A 2015

K-11 5.4 5.14 0.30 85 +0.9 3.8 6.5 AcceptableK-12 13.1 12.28 0.58 86 +1.4 9.2 15.4 AcceptableK-13 33.9 31.00 1.32 85 +2.2 23.2 38.8 Acceptable

CEAng/mL (ug/L)

BECKMAN ACCESS/2

K-C 2015K-B 2015K-A 2015

K-11 9.3 9.55 0.62 84 -0.4 7.1 12.0 AcceptableK-12 15.6 15.20 0.97 83 +0.4 11.3 19.0 AcceptableK-13 32.8 34.71 1.99 84 -1.0 26.0 43.4 AcceptableK-14 16.2 17.48 1.04 83 -1.2 13.1 21.9 AcceptableK-15 16.2 17.49 1.15 83 -1.1 13.1 21.9 Acceptable

Cortisol, serumug/dL

BECKMAN ACCESS/2K-C 2015

K-B 2015

K-A 2015

K-11 15 16.3 1.0 293 -1.3 13 20 AcceptableK-12 223 234.6 10.7 293 -1.1 202 267 AcceptableK-13 647 665.6 36.8 292 -0.5 555 777 Acceptable

Ferritinng/mL (ug/L)

ABBOTT ARCHITECT i

K-C 2015K-B 2015K-A 2015

0001


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12/11/2015

K-C 2015 Ligand Assay - GeneralE V A L U A T I O N

ORIGINAL


Specimen Mean

YourResult S.D.


YourGrade


K-11 1.2 1.19 0.20 169 0.0 0.5 1.9 AcceptableK-12 2.5 2.64 0.25 174 -0.6 1.8 3.4 AcceptableK-13 6.1 5.89 0.52 174 +0.4 4.3 7.5 Acceptable

TestUnit of Measure

Peer Group

Folate, serumng/mL

BECKMAN ACCESS/2


Survey -100------------Mean-----------+100

K-C 2015K-B 2015K-A 2015

K-11 3.9 3.61 0.38 279 +0.8 2.4 4.8 AcceptableK-12 110.1 111.96 4.78 292 -0.4 97.6 126.4 AcceptableK-13 259.1 264.67 9.99 293 -0.6 234.6 294.7 AcceptableK-14 91.3 96.97 4.18 294 -1.4 84.4 109.6 AcceptableK-15 98.7 97.46 4.75 294 +0.3 83.2 111.8 Acceptable

hCG, serum, quantmIU/mL (IU/L)

ABBOTT ARCHITECT iK-C 2015

K-B 2015

K-A 2015

K-11 56 7 [20]K-12 88 7 [20]K-13 258 7 [20]K-14 102 7 [20]K-15 121 7 [20]

Immunoglobulin EIU/mL (kIU/L)

BECKMAN ACCESS/2

K-11 138.9 147.88 5.74 162 -1.6 130.6 165.2 AcceptableK-12 178.0 195.96 8.96 162 -2.0 169.0 222.9 AcceptableK-13 318.6 350.52 23.18 163 -1.4 280.9 420.1 AcceptableK-14 194.8 207.13 11.17 163 -1.1 173.6 240.7 AcceptableK-15 193.0 206.59 10.67 162 -1.3 174.5 238.7 Acceptable

Triiodothyronineng/dL


K-B 2015

K-A 2015

0001


Page 3 of 7






28010625

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12/11/2015


ORIGINAL


Specimen Mean

YourResult S.D.


YourGrade


K-11 3.4 3.56 0.22 171 -0.7 2.9 4.3 AcceptableK-12 3.9 4.35 0.23 168 -2.0 3.6 5.1 AcceptableK-13 8.6 9.83 0.84 172 -1.5 7.3 12.4 Acceptable

TestUnit of Measure

Peer Group

Free T-3pg/mL

ABBOTT ARCHITECT i


Survey -100------------Mean-----------+100

K-C 2015K-B 2015K-A 2015

K-11 5.7 5.46 0.35 202 +0.7 4.3 6.6 AcceptableK-12 5.4 5.73 0.35 201 -0.9 4.5 6.9 AcceptableK-13 11.3 10.38 0.44 200 +2.1 8.3 12.5 AcceptableK-14 6.1 6.38 0.33 200 -0.8 5.1 7.7 AcceptableK-15 6.2 6.38 0.34 202 -0.5 5.1 7.7 Acceptable

Thyroxineug/dL


K-B 2015

K-A 2015

K-11 0.8 0.90 0.04 331 -2.3 0.7 1.1 AcceptableK-12 0.8 0.93 0.05 329 -2.7 0.7 1.1 AcceptableK-13 1.7 1.61 0.07 331 +1.2 1.3 1.9 AcceptableK-14 0.9 1.00 0.05 332 -2.2 0.8 1.2 AcceptableK-15 0.9 1.01 0.05 332 -2.1 0.8 1.2 Acceptable

Thyroxine, freeng/dL


K-B 2015

K-A 2015

K-11 4.52 4.775 0.229 356 -1.1 4.08 5.47 AcceptableK-12 5.32 5.394 0.253 356 -0.3 4.63 6.16 AcceptableK-13 14.38 15.633 0.706 352 -1.8 13.51 17.76 AcceptableK-14 5.69 5.762 0.258 356 -0.3 4.98 6.54 AcceptableK-15 5.57 5.738 0.258 353 -0.7 4.96 6.52 Acceptable

Thyroid Stim HormoneuIU/mL (mIU/L)


K-B 2015

K-A 2015

0001


Page 4 of 7






28010625

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12/11/2015


ORIGINAL


Specimen Mean

YourResult S.D.


YourGrade


K-11 164 167.7 13.4 182 -0.3 127 208 AcceptableK-12 167 175.2 12.8 180 -0.6 136 214 AcceptableK-13 422 419.4 25.5 184 +0.1 342 496 Acceptable

TestUnit of Measure

Peer Group

Vitamin B-12pg/mL

BECKMAN ACCESS/2


Survey -100------------Mean-----------+100

K-C 2015K-B 2015K-A 2015

K-20 6.53 6.673 0.371 397 -0.4 5.55 7.79 AcceptableK-21 9.05 8.973 0.477 395 +0.2 7.54 10.41 Acceptable

Prostate Specific Agng/mL (ug/L)

ABBOTT ARCHITECT i

K-C 2015K-B 2015K-A 2015

K-20 1.60 1.529 0.077 151 +0.9 1.29 1.77 AcceptableK-21 0.92 0.912 0.038 149 +0.2 0.71 1.12 Acceptable

PSA, freeng/mL (ug/L)

ABBOTT ARCHITECT i

K-C 2015K-B 2015K-A 2015

FOL-05 467 9 [20]FOL-06 301 9 [20]

RBC Folateng/mL

BECKMAN ACCESS/2K-B 2015K-A 2015

x: Result is outside the acceptable limits

0001


Page 5 of 7






28010625

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12/11/2015


ORIGINAL

Subspecialty :7181660 General ImmunologyProficiency Event

2015 1

Regulated Analyte Test Event Score %

Proficiency Event2015 2

Proficiency Event2015 3 Cumulative CLIA

'88 PerformanceInterpretation

Current EventPerformanceInterpretationTest Event Score % Test Event Score %

CAP

CAP #:

Pending100S-A 100S-BAlpha-1-Antitrypsin Successful <4>/ /55 5 5

Satisfactory100K-A 100K-C100K-BAlpha-Fetoprotein Successful/ / /555 5 5 5

Pending100S-A 100S-BAntinuclear Antibody Successful <4>/ /55 5 5

Pending100S-A 100S-BAntistreptolysin O Successful <4>/ /55 5 5

Satisfactory100VM-A 100VM-C100VM-BAnti-HIV Successful/ / /555 5 5 5

Pending100S-A 100S-BComplement C3 Successful <4>/ /55 5 5

Pending100S-A 100S-BComplement C4 Successful <4>/ /55 5 5

Satisfactory100VM-A 100VM-C100VM-BHepatitis (HBsAg) Successful/ / /555 5 5 5

Satisfactory100VM-A 100VM-C100VM-BHepatitis (Anti-HBc) Successful/ / /555 5 5 5

Pending100S-A 100S-BIgA Successful <4>/ /55 5 5

Pending100S-A 100S-BIgG Successful <4>/ /55 5 5

Pending100S-A 100S-BIgE Successful <4>/ /55 5 5

Pending100S-A 80S-BIgM Successful <4>/ /55 4 5

Pending100S-A 100S-BRheumatoid Factor Successful <4>/ /55 5 5

Pending100S-A 100S-BRubella Successful <4>/ /55 5 5

General Immunology 75/75 100 74/75 99 20/20 Satisfactory Successful

<4> Scorecard performance pending future evaluation or may not be applicable due to discontinued testing or use of a waived method.

100

0001


Page 6 of 7






28010625

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12/11/2015


ORIGINAL

Subspecialty :7181660 EndocrinologyProficiency Event

2015 1

Regulated Analyte Test Event Score %

Proficiency Event2015 2

Proficiency Event2015 3 Cumulative CLIA

'88 PerformanceInterpretation

Current EventPerformanceInterpretationTest Event Score % Test Event Score %

CAP

CAP #:

Satisfactory100K-A 100K-C100K-BCortisol Successful/ / /555 5 5 5

Satisfactory100K-A 100K-C100K-BThyroxine, Free (T4, Free) Successful/ / /555 5 5 5

Satisfactory100K-A 100K-C100K-BhCG Successful/ / /555 5 5 5

Satisfactory100K-A 100K-C100K-BTriiodothyronine (T3) Successful/ / /555 5 5 5

Satisfactory100K-A 100K-C100K-BTSH Successful/ / /555 5 5 5

Satisfactory100K-A 100K-C100K-BThyroxine (T4, Total) Successful/ / /555 5 5 5

Endocrinology 30/30 100 30/30 100 30/30 Satisfactory Successful100

0001


Page 7 of 7






28010625

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12/11/2015


ORIGINAL

EVALUATIONORIGINAL

VR3-B 2015 Infectious Disease Serology

INSTITUTION:

ATTENTION:

CAP NUMBER:




Kit#7181660-01 1


Ana Velasquez

Next Mailing Date:

3/14/2016

COPIED TO: LAP CAP

LEGEND: Exception Reason Codes appearing in this evaluation:[26] = Educational challenge.[33] = Specimen determined to be unsatisfactory after contacting the CAP.

Reviewed By Date

0001


Page 1 of 3

TestMethod Specimen Your Result Intended Response Your Grade

CMV, IgGVR3-09 PRESENTABBOTT ARCHITECT i PRESENT Good

CMV, IgMVR3-09 PRESENTDIASORIN LIAISON PRESENT Good

EBV, VCA, IgGVR3-10OTHER ABSENT [26]

EBV, VCA, IgMVR3-10DIASORIN LIAISON ABSENT [26]

HSV I, IgGVR3-12 ABSENTOTHER ABSENT Good

HSVII, IgGVR3-12 PRESENTOTHER PRESENT Good

M pneu, IgGVR3-13 [33]

M pneu, IgMVR3-13 [33]

M pneu, Total AbVR3-13 [33]

Toxo, IgGVR3-15 ABSENTABBOTT ARCHITECT i ABSENT Good

0001


Page 2 of 3






28004213

11/2/2015

12/10/2015

VR3-B 2015 Infectious Disease SerologyE V A L U A T I O N

ORIGINAL

TestMethod Specimen Your Result Intended Response Your Grade

Toxo, IgMVR3-15 ABSENTABBOTT ARCHITECT i ABSENT Good

VZV, IgGVR3-16 PRESENTBIOMERIEUX VIDAS/MINI PRESENT Good

0001


Page 3 of 3






28004213

11/2/2015

12/10/2015

VR3-B 2015 Infectious Disease SerologyE V A L U A T I O N

ORIGINAL

EVALUATIONORIGINAL

VITD-B 2015 25-OH Vitamin D

INSTITUTION:

ATTENTION:

CAP NUMBER:




Kit#7181660-01 1


Ana Velasquez

Next Mailing Date:

4/25/2016

COPIED TO: LAP CAP

LEGEND: Exception Reason Codes appearing in this evaluation:<NONE>

Reviewed By Date

0001


Page 1 of 2


Specimen Mean

YourResult S.D.


YourGrade


VITD-04 43.5 45.93 3.77 183 -0.6 34.6 57.3 AcceptableVITD-05 30.0 34.54 2.85 182 -1.6 25.9 43.1 AcceptableVITD-06 19.5 20.21 1.94 185 -0.4 14.3 26.1 Acceptable

TestUnit of Measure

Peer Group

25 OH Vitamin Dng/mL

DIASORIN LIAISON


Survey -100------------Mean-----------+100

VITD-B 2015VITD-A 2015

0001


Page 2 of 2






28017888

11/2/2015

11/30/2015

VITD-B 2015 25-OH Vitamin DE V A L U A T I O N

ORIGINAL

College of American Pathologists325 Waukegan Road, Northfield, Illinois 60093-2750800-323-4040 - http://www.cap.org

Advancing Excellence

CAP Number: Kit #:Institution:Attention:City/State:

7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:

Laboratorio Medico Las AmericasAna VelasquezMedellin, ANT 050034

09/28/201511/02/201504/04/2016

E V A L U A T I O NORIGINAL


LN8-B 2015 Reproductive Endocrinology Calibration Verification/Linearity

Executive Summary

Analyte Calibration Verification Linearity Evaluation Page #

Estradiol pg/mL Verified from 30.00 to 3129.00 (d) Linear from 30.00 to 1779.00 (d) 2 - 3FSH mIU/mL (IU/L) Verified from 2.55 to 169.15 (d) Linear from 2.55 to 169.15 (d) 4 - 5hCG mIU/mL (IU/L) Verified from 26.90 to 3164.60 Linear from 26.90 to 631.30 6 - 7

LH mIU/mL (U/L) Different Linear from 1.20 to 117.80 8 - 9Progesterone ng/mL Verified from 0.85 to 37.75 Linear from 0.85 to 37.75 10 - 11

Prolactin ng/mL (µg/L) Verified from 3.40 to 348.05 (d) Linear from 3.40 to 198.90 (d) 12 - 13*Testosterone ng/dL Verified from 25.770 to 1584.320 (d) Linear from 25.770 to 1216.900 (d) 14 - 15*

Note: For results of Different, see the Calibration Verification Troubleshooting Guide and Investigation Checklist.* This range does not include all reported specimens. Review your results to determine if excluded specimens reveal possible analytical problems.

(d) This evaluation result includes at least one diluted specimen.

Reviewed by_________________________________________ Date______________




7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:


09/28/201511/02/201504/04/2016



LN8-B 2015 Reproductive Endocrinology Calibration Verification/LinearityEstradiol pg/mL Calibration Verification Evaluation

Evaluation Result: Verified from 30.00 to 3129.00Peer Method: ABBOTT ARCHITECT i

Allowable Error: 12.5% or 15 pg/mL,whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN

Difference AllowableError

LN8-08LN8-09LN8-10LN8-11LN8-12LN8-13LN8-14

29.0 408.0 794.0

1019.01469.01749.03180.0

31.0 413.0 818.0

1103.01460.01809.03078.0

30.00 410.50 806.00

1061.001464.501779.003129.00

26.85 383.28 763.93 990.13

1342.931696.102888.16

60606060585856

3.15 pg/mL7.1%5.5%7.2%9.1%4.9%8.3%

± 15.00 pg/mL± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%

****

* Diluted specimen

Calibration Verification Plot: Percent Differences withAllowable Error Limits

0 500 1000 1500 2000 2500 3000

-60

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Peer Mean

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Not DilutedDiluted

Peer Results Summary Table Peer Group Size: 60

Calibration Verification Linearity EvaluationRange % Verified % Different % Linear % Nonlinear % Imprecise

LN8-08 - 14LN8-08 - 13LN8-08 - 11

88.3 3.3 3.3

5.00.00.0

* LN8-14 is not evaluated for linearity

*93.3 3.3

*1.70.0

*0.01.7




7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:


09/28/201511/02/201504/04/2016



LN8-B 2015 Reproductive Endocrinology Calibration Verification/LinearityEstradiol pg/mL Linearity Evaluation

Method: ABBOTT ARCHITECT iEvaluation Result: Linear from 30.00 to 1779.00 Evaluation Type: Standard

Goal for Total Error (TE): 25%Mean of Included Results: 925.17 pg/mL

Specimen Assay1

Assay2

YourMean

Best-fitTarget

RelativeConcentration

LN8-08LN8-09LN8-10LN8-11LN8-12LN8-13LN8-14

29.0 408.0 794.0

1019.01469.01749.03180.0

31.0 413.0 818.0

1103.01460.01809.03078.0

30.00 410.50 806.00

1061.001464.501779.003129.00

56.45 403.94 751.42

1098.911446.401793.88

0.0000.2000.4000.6000.8001.000

****

* Diluted specimen § LN8-14 is not evaluated for linearity.

§

Linearity Plot 1: Reported Resultswith Best-fit Line

0.0 0.2 0.4 0.6 0.8 1.0

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Assa

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t pg/

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Relative Concentration

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Linearity Plot 2: Differences withLimits of Acceptable Imprecision

0.0 0.2 0.4 0.6 0.8 1.0

-200

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-TE

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Best-fit lineExtended line

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Included in best-fit lineExcluded from best-fit line

Diluted & Included in best-fit lineDiluted & Excluded from best-fit line

Your plot has one or more points within your linear range thatfall outside of the shaded area. Since your evaluation is Linear,no remedial action is necessary.Points can fall outside of the shaded area for two reasons: 1) an average is used to estimate imprecision, so many small differences can offset a few large differences, and 2) clinically insignificant nonlinearity (curved fit) can contribute to differences between your results and the best-fit straight line.Larger differences may be an early warning sign of nonlinearity,poor repeatability, or poor fit.




7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:


09/28/201511/02/201504/04/2016



LN8-B 2015 Reproductive Endocrinology Calibration Verification/LinearityFSH mIU/mL (IU/L) Calibration Verification Evaluation


Allowable Error: 10% or 2 mIU/mL (IU/L),whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN8-08LN8-09LN8-10LN8-11LN8-12LN8-13

2.5 38.4 69.0

104.3145.9166.9

2.6 36.7 68.0

105.8142.9171.4

2.55 37.55 68.50

105.05144.40169.15

2.55 36.73 72.06

110.19139.81169.11

828383837874

0.00 mIU/mL2.2%-4.9%-4.7%3.3%0.0%

± 2.00 mIU/mL± 10.0%± 10.0%± 10.0%± 10.0%± 10.0%

Note: mIU/mL is equivalent to IU/L.

** Diluted specimen


0 50 100 150

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Peer Mean

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Not DilutedDiluted



LN8-08 - 13LN8-08 - 12LN8-09 - 13LN8-08 - 11

72.3 7.2 1.2 8.4

10.8 0.0 0.0 0.0

59.015.7 1.219.3

0.01.20.00.0

0.00.00.03.6




7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:


09/28/201511/02/201504/04/2016



LN8-B 2015 Reproductive Endocrinology Calibration Verification/LinearityFSH mIU/mL (IU/L) Linearity Evaluation

Method: ABBOTT ARCHITECT i

Evaluation Result: Linear from 2.55 to 144.40(extended to 169.15 with dilution)

Evaluation Type: Diluted/ExtendedGoal for Total Error (TE): 20%

Mean of Included Results: 71.61 mIU/mL (IU/L)

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN8-08LN8-09LN8-10LN8-11LN8-12LN8-13

2.5 38.4 69.0

104.3145.9166.9

2.6 36.7 68.0

105.8142.9171.4

2.55 37.55 68.50

105.05144.40169.15

1.37 36.49 71.61

106.73141.85176.97

0.0000.2000.4000.6000.8001.000*

* Diluted specimen


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Linearity Plot 2: Differences withAllowable Error Limits

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Your Diluted Specimen(s) Analysis

SpecimenReplicateDifference 1 Your Mean

Best-fitTarget

DifferenceFrom Target 2

AllowableError Evaluation

1 Limit for replicate difference = 6.7% of Best-fit Target2 Allowable Error = 10% of Best-fit Target

Included in linear rangeLN8-13 4.5 169.15 176.97 -7.82 ± 17.70




7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:


09/28/201511/02/201504/04/2016



LN8-B 2015 Reproductive Endocrinology Calibration Verification/LinearityhCG mIU/mL (IU/L) Calibration Verification Evaluation


Allowable Error: 12.5% or 5 mIU/mL (IU/L),whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN8-08LN8-09LN8-10LN8-11LN8-12LN8-13LN8-14

26.2 144.6 268.8 387.4 501.6 608.0

3133.5

27.6 142.6 270.6 383.1 522.1 654.6

3195.7

26.90 143.60 269.70 385.25 511.85 631.30

3164.60

27.26 147.50 270.85 394.97 522.88 638.78

3255.77

82828282828181

-0.36 mIU/mL-2.6%-0.4%-2.5%-2.1%-1.2%-2.8%

± 5.00 mIU/mL± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%



0 500 1000 1500 2000 2500 3000

-40

-20

0

20

40

Perc

ent D

iffer

ence

Peer Mean

◆◆ ◆ ◆

◆ ◆ ◆

◆

◆◆

◆◆

◆

◆



LN8-08 - 14LN8-08 - 13LN8-09 - 14LN8-08 - 12

96.3 0.0 1.2 1.2

1.20.00.00.0


*97.6

* 1.2

*0.0

*0.0

*1.2

*0.0




7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:


09/28/201511/02/201504/04/2016



LN8-B 2015 Reproductive Endocrinology Calibration Verification/LinearityhCG mIU/mL (IU/L) Linearity Evaluation


Goal for Total Error (TE): 25%Mean of Included Results: 328.10 mIU/mL (IU/L)

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN8-08LN8-09LN8-10LN8-11LN8-12LN8-13LN8-14

26.2 144.6 268.8 387.4 501.6 608.0

3133.5

27.6 142.6 270.6 383.1 522.1 654.6

3195.7

26.90 143.60 269.70 385.25 511.85 631.30

3164.60

25.08146.29267.50388.70509.91631.12

0.0000.2000.4000.6000.8001.000

§ LN8-14 is not evaluated for linearity.

§


0.0 0.2 0.4 0.6 0.8 1.0

0

100

200

300

400

500

600

Assa

y R

esul

t mIU

/mL

(IU/L

)


◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

◆


0.0 0.2 0.4 0.6 0.8 1.0

-50

0

50

Diff

eren

ce fr

om B

est-f

it Li

ne m

IU/m

L (IU

/L)


◆◆

◆◆

◆

◆

◆

◆

◆

◆

◆

◆

-TE

-TE/4

TE/4

TE


◆

●





7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:


09/28/201511/02/201504/04/2016



LN8-B 2015 Reproductive Endocrinology Calibration Verification/LinearityLH mIU/mL (U/L) Calibration Verification Evaluation

Evaluation Result: DifferentPeer Method: ABBOTT ARCHITECT i

Allowable Error: 10% or 3 mIU/mL (U/L),whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN8-08LN8-09LN8-10LN8-11LN8-12LN8-13

1.2 24.5 46.8 72.6 96.3

119.7

1.2 25.8 44.2 71.3 95.2

115.9

1.20 25.15 45.50 71.95 95.75

117.80

1.38 28.58 55.36 82.91

108.00134.26

737373737373

-0.18 mIU/mL-3.43 mIU/mL

-17.8%-13.2%-11.3%-12.3%

± 3.00 mIU/mL± 3.00 mIU/mL

± 10.0%± 10.0%± 10.0%± 10.0%

Note: mIU/mL is equivalent to U/L.


0 20 40 60 80 100 120

-40

-20

0

20

40

Perc

ent D

iffer

ence

Peer Mean 1 limit(s) too large to display

◆◆

◆

◆◆ ◆

◆

◆

◆

◆◆

◆



LN8-08 - 13LN8-08 - 11

86.3 2.7

11.0 0.0

98.6 1.4

0.00.0

0.00.0




7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:


09/28/201511/02/201504/04/2016



LN8-B 2015 Reproductive Endocrinology Calibration Verification/LinearityLH mIU/mL (U/L) Linearity Evaluation


Goal for Total Error (TE): 20%Mean of Included Results: 59.56 mIU/mL (U/L)

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN8-08LN8-09LN8-10LN8-11LN8-12LN8-13

1.2 24.5 46.8 72.6 96.3

119.7

1.2 25.8 44.2 71.3 95.2

115.9

1.20 25.15 45.50 71.95 95.75

117.80

0.90 24.36 47.83 71.29 94.75

118.22

0.0000.2000.4000.6000.8001.000


0.0 0.2 0.4 0.6 0.8 1.0

0

20

40

60

80

100

120

Assa

y R

esul

t mIU

/mL

(U/L

)


◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

◆


0.0 0.2 0.4 0.6 0.8 1.0

-10

-5

0

5

10

Diff

eren

ce fr

om B

est-f

it Li

ne m

IU/m

L (U

/L)


◆ ◆

◆

◆ ◆ ◆

◆

◆

◆

◆◆

◆

-TE

-TE/4

TE/4

TE

◆

●





7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:


09/28/201511/02/201504/04/2016



LN8-B 2015 Reproductive Endocrinology Calibration Verification/LinearityProgesterone ng/mL Calibration Verification Evaluation


Allowable Error: 12.5% or 1 ng/mL,whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN8-08LN8-09LN8-10LN8-11LN8-12LN8-13

0.9 9.1

17.325.237.8

0.8 8.7

17.725.637.7

> 40.0 > 40.0

0.85 8.90

17.5025.4037.75

0.91 9.43

18.5428.4135.6639.12

646464645640

-0.06 ng/mL-5.6%-5.6%

-10.6%5.9%

± 1.00 ng/mL± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%


0 10 20 30

-40

-20

0

20

40

Perc

ent D

iffer

ence


◆◆

◆

◆

◆

◆

◆◆

◆

◆



LN8-08 - 13LN8-08 - 12LN8-08 - 11

39.126.618.8

12.5 1.6 1.6

20.348.429.7

0.00.00.0

0.00.01.6




7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:


09/28/201511/02/201504/04/2016



LN8-B 2015 Reproductive Endocrinology Calibration Verification/LinearityProgesterone ng/mL Linearity Evaluation


Goal for Total Error (TE): 25%Mean of Included Results: 18.08 ng/mL

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN8-08LN8-09LN8-10LN8-11LN8-12LN8-13

0.9 9.1

17.325.237.8

0.8 8.7

17.725.637.7

> 40.0 > 40.0

0.85 8.9017.5025.4037.75

0.02 9.05

18.0827.1136.14

0.0000.2000.4000.6000.8001.000


0.0 0.2 0.4 0.6 0.8

0

10

20

30

Assa

y R

esul

t ng/

mL


◆

◆

◆

◆

◆

◆

◆

◆

◆

◆


0.0 0.2 0.4 0.6 0.8

-4

-2

0

2

4

Diff

eren

ce fr

om B

est-f

it Li

ne n

g/m

L


◆

◆

◆

◆

◆

◆

◆ ◆

◆

◆

-TE

-TE/4

TE/4

TE

◆

●






7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:


09/28/201511/02/201504/04/2016



LN8-B 2015 Reproductive Endocrinology Calibration Verification/LinearityProlactin ng/mL (µg/L) Calibration Verification Evaluation


Allowable Error: 12.5% or 3 ng/mL (µg/L),whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN8-08LN8-09LN8-10LN8-11LN8-12LN8-13LN8-14

3.4 55.3

112.2163.5194.7233.0341.1

3.4 55.2

108.9168.3203.1236.9355.0

3.40 55.25

110.55165.90198.90234.95348.05

3.39 54.17

109.43165.54199.77247.09360.73

78797979757573

0.01 ng/mL2.0%1.0%0.2%-0.4%-4.9%-3.5%

± 3.00 ng/mL± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%

Note: ng/mL is equivalent to µg/L.

***

* Diluted specimen


0 100 200 300

-50

0

50

Perc

ent D

iffer

ence

Peer Mean

◆ ◆ ◆◆ ◆

◆ ◆◆ ◆

◆ ◆ ◆◆

◆◆◆ ◆

◆◆ ◆

◆

◆

Not DilutedDiluted



LN8-08 - 14LN8-08 - 13LN8-09 - 14LN8-08 - 12LN8-09 - 13LN8-08 - 11

67.1 3.8 1.3 3.8 0.0 5.1

17.7 0.0 0.0 0.0 0.0 1.3


*65.8

* 5.1 1.326.6

*0.0

*0.00.00.0

*1.3

*0.00.00.0




7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:


09/28/201511/02/201504/04/2016



LN8-B 2015 Reproductive Endocrinology Calibration Verification/LinearityProlactin ng/mL (µg/L) Linearity Evaluation




Mean of Included Results: 83.78 ng/mL (µg/L)

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN8-08LN8-09LN8-10LN8-11LN8-12LN8-13LN8-14

3.4 55.3

112.2163.5194.7233.0341.1

3.4 55.2

108.9168.3203.1236.9355.0

3.40 55.25

110.55165.90198.90234.95348.05

2.35 56.63

110.92165.20219.48273.76

0.0000.2000.4000.6000.8001.000

***

* Diluted specimen § LN8-14 is not evaluated for linearity.

§


0.0 0.2 0.4 0.6 0.8 1.0

0

50

100

150

200

250

Assa

y R

esul

t ng/

mL

(µg/

L)


◆

◆

◆

◆

◆

◆

◆

◆

●

●

●

●

●

●

●

●


0.0 0.2 0.4 0.6 0.8 1.0

-60

-40

-20

020

4060

◆◆

◆◆

◆◆ ◆

◆

●

●

●

●

●

●

●

●


Diff

eren

ce fr

om B

est-f

it Li

ne n

g/m

L (µ

g/L)


◆

●

◆

●





Best-fitTarget



1 Limit for replicate difference = 8.3% of Best-fit Target2 Allowable Error = 12.5% of Best-fit Target

Included in linear rangeLN8-12 8.4 198.90 219.48 -20.58 ± 27.44Excluded: Diff. exceeds allowable errorLN8-13 3.9 234.95 273.76 -38.81 ± 34.22




7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:


09/28/201511/02/201504/04/2016



LN8-B 2015 Reproductive Endocrinology Calibration Verification/LinearityTestosterone ng/dL Calibration Verification Evaluation


Allowable Error: 12.5% or 10 ng/dL,whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN8-08LN8-09LN8-10LN8-11LN8-12LN8-13

26.53 289.55 574.49 881.92

1196.281566.01

25.01 293.01 532.96 825.111237.521602.63

25.770 291.280 553.725 853.515

1216.9001584.320

22.174 285.058 545.670 822.510

1115.5641412.116

585858585451

3.596 ng/dL2.2%1.5%3.8%9.1%

12.2%

± 10.000 ng/dL± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%

**

* Diluted specimen


0 200 400 600 800 1000 1200 1400

-40

-20

0

20

40

Perc

ent D

iffer

ence

Peer Mean

◆

◆

◆◆ ◆

◆◆

◆

◆◆

◆◆

◆◆◆◆

◆

◆

Not DilutedDiluted



LN8-08 - 13LN8-08 - 12LN8-08 - 11

75.9 8.6 6.9

6.91.70.0

77.613.8 8.6

0.00.00.0

0.00.00.0




7181660-01 01 28017235Kit ID:Kit Mailed:

Next Mailing Date:


09/28/201511/02/201504/04/2016



LN8-B 2015 Reproductive Endocrinology Calibration Verification/LinearityTestosterone ng/dL Linearity Evaluation




Mean of Included Results: 431.072 ng/dL

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN8-08LN8-09LN8-10LN8-11LN8-12LN8-13

26.53 289.55 574.49 881.92

1196.281566.01

25.01 293.01 532.96 825.11

1237.521602.63

25.770 291.280 553.725 853.515

1216.9001584.320

19.221 293.788 568.356 842.924

1117.4921392.060

0.0000.2000.4000.6000.8001.000

**

* Diluted specimen


0.0 0.2 0.4 0.6 0.8 1.0

0

500

1000

1500

Assa

y R

esul

t ng/

dL


◆

◆

◆

◆

◆

◆

◆

◆

●

●

●

●

●

●

●

●


0.0 0.2 0.4 0.6 0.8 1.0

-200

020

0

◆◆ ◆

◆

◆ ◆

◆◆

●

●

●

●

●

●

●

●


Diff

eren

ce fr

om B

est-f

it Li

ne n

g/dL


◆

●

◆

●





Best-fitTarget




Included in linear rangeLN8-12 41.24 1216.900 1117.493 99.407 ± 139.687Excluded: Diff. exceeds allowable errorLN8-13 36.62 1584.320 1392.061 192.259 ± 174.008

EV

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EVALUATIONORIGINAL

TM-B 2015 Tumor Markers

INSTITUTION:

ATTENTION:

CAP NUMBER:




Kit#7181660-01 1


Ana Velasquez

Next Mailing Date:

1/18/2016

COPIED TO: LAP CAP

LEGEND: Exception Reason Codes appearing in this evaluation:[20] = No appropriate target/response cannot be graded.

Reviewed By Date

0001


Page 1 of 3


Specimen Mean

YourResult S.D.


YourGrade


TM-04 19.3 28.21 9.66 10 -0.9 0.0 57.2 AcceptableTM-05 12.6 18.50 5.60 10 -1.1 1.6 35.4 AcceptableTM-06 29.0 40.75 13.43 10 -0.9 0.4 81.1 Acceptable

TestUnit of Measure

Peer Group

ACTHpg/mL

DIASORIN


Survey -100------------Mean-----------+100

TM-B 2015

TM-04 1.3 7 [20]TM-05 0.5 5 [20]TM-06 3.1 7 [20]

Beta-2-microglobulinug/mL (mg/L)

DIASORIN LIAISON

TM-04 66.6 61.74 2.83 202 +1.7 53.2 70.3 AcceptableTM-05 21.0 18.63 1.03 203 +2.3 15.5 21.8 AcceptableTM-06 185.9 169.89 7.08 202 +2.3 148.6 191.2 Acceptable

CA 125U/mL

ABBOTT ARCHITECT i

TM-B 2015TM-A 2015TM-B 2014

TM-04 21.1 20.85 1.12 11 +0.2 17.4 24.3 AcceptableTM-05 8.8 8.83 0.71 12 0.0 6.6 11.0 AcceptableTM-06 37.8 40.03 2.97 12 -0.8 31.1 49.0 Acceptable

CA 15-3U/mL

BECKMAN ACCESS/2

TM-B 2015TM-A 2015TM-B 2014

TM-04 48.8 8 [20]TM-05 23.0 8 [20]TM-06 275.3 8 [20]

CA 19-9U/mL

OTHER

0001


Page 2 of 3






28016325

7/20/2015

8/19/2015

TM-B 2015 Tumor MarkersE V A L U A T I O N

ORIGINAL


Specimen Mean

YourResult S.D.


YourGrade


TM-04 27.4 33.72 1.74 38 -3.6 28.5 39.0 UnacceptableTM-05 7.4 8.74 0.47 39 -2.9 7.3 10.2 AcceptableTM-06 45.4 55.33 2.85 38 -3.5 46.7 63.9 Unacceptable

TestUnit of Measure

Peer Group

Thyroglobulinng/mL

BECKMAN ACCESS/2


Survey -100------------Mean-----------+100

TM-B 2015TM-A 2015TM-B 2014

x: Result is outside the acceptable limits

0001


Page 3 of 3






28016325

7/20/2015

8/19/2015

TM-B 2015 Tumor MarkersE V A L U A T I O N

ORIGINAL




7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/Linearity

Executive Summary

Analyte Calibration Verification Linearity Evaluation Page #

AFP ng/mL (µg/L) *** Linear from 1.00 to 807.05 2CEA ng/mL (µg/L) Verified from 0.55 to 725.30 Linear from 0.55 to 725.30 3 - 4

Cortisol µg/dL Verified from 1.05 to 58.65 Linear from 1.05 to 58.65 5 - 6Ferritin ng/mL (µg/L) Verified from 3.90 to 1976.60 (d) Linear from 3.90 to 1976.60 (d) 7 - 8

Folate ng/mL Different Linear from 0.240 to 5.850 9 - 10hCG mIU/mL (IU/L) Verified from 9.30 to 6145.85 Linear from 9.30 to 693.95 11 - 12

Triiodothyronine T3 ng/dL Verified from 50.40 to 532.45 Linear from 50.40 to 532.45 13 - 14* *Thyroxine (Total) T4 µg/dL Verified from 1.05 to 26.00 (d) Linear from 1.05 to 19.90 15 - 16*

TSH µIU/mL (mIU/L) Verified from 0.0230 to 87.1240 Linear from 0.0230 to 87.1240 17 - 18Vitamin B-12 pg/mL Verified from 86.5 to 1321.5 Imprecise 19 - 21

Note: For results of Different, see the Calibration Verification Troubleshooting Guide and Investigation Checklist.* This range does not include all reported specimens. Review your results to determine if excluded specimens reveal possible analytical problems.

*** No Peer Group(d) This evaluation result includes at least one diluted specimen.

Reviewed by_________________________________________ Date______________




7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityAFP ng/mL (µg/L) Linearity Evaluation

Method: BECKMAN ACCESS/2Evaluation Result: Linear from 1.00 to 807.05 Evaluation Type: Standard

Goal for Total Error (TE): 25%Mean of Included Results: 394.47 ng/mL (µg/L)

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

1.0161.1313.2464.8627.9804.1

1.0157.1312.6462.6618.2810.0

1.00159.10312.90463.70623.05807.05

< 0155.63314.85474.08633.31792.53

0.0000.2000.4000.6000.8001.000


0.0 0.2 0.4 0.6 0.8 1.0

0

200

400

600

800

Assa

y Re

sult

ng/m

L (µ

g/L)


◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

◆


0.0 0.2 0.4 0.6 0.8 1.0

-100

-50

0

50

100

Diffe

renc

e fro

m B

est-f

it Li

ne n

g/m

L (µ

g/L)


◆ ◆

◆

◆◆

◆

◆◆

◆

◆◆

◆

-TE

-TE/4

TE/4

TE

◆

●





7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityCEA ng/mL (µg/L) Calibration Verification Evaluation

Evaluation Result: Verified from 0.55 to 725.30Peer Method: BECKMAN ACCESS/2

Allowable Error: 12.5% or 2.3 ng/mL (µg/L),whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

0.5140.3283.0426.5601.6736.0

0.6138.4281.3426.7569.3714.6

0.55139.35282.15426.60585.45725.30

0.60139.56279.39414.12564.89717.28

131313131313

-0.05 ng/mL-0.2%1.0%3.0%3.6%1.1%

± 2.30 ng/mL± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%



0 200 400 600

-40

-20

0

20

40

Perc

ent D

iffer

ence


◆

◆ ◆◆

◆

◆◆ ◆

◆◆

◆ ◆



LN5-01 - 06 92.3 7.7 100.0 0.0 0.0




7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityCEA ng/mL (µg/L) Linearity Evaluation


Goal for Total Error (TE): 25%Mean of Included Results: 359.90 ng/mL (µg/L)

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

0.5140.3283.0426.5601.6736.0

0.6138.4281.3426.7569.3714.6

0.55139.35282.15426.60585.45725.30

< 0141.05286.95432.85578.75724.65

0.0000.2000.4000.6000.8001.000


0.0 0.2 0.4 0.6 0.8 1.0

0

200

400

600

Assa

y Re

sult

ng/m

L (µ

g/L)


◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

◆


0.0 0.2 0.4 0.6 0.8 1.0

-50

0

50

Diffe

renc

e fro

m B

est-f

it Li

ne n

g/m

L (µ

g/L)


◆◆

◆ ◆

◆

◆◆

◆◆ ◆

◆ ◆

-TE

-TE/4

TE/4

TE

◆

●





7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityCortisol µg/dL Calibration Verification Evaluation


Allowable Error: 12.5% or 1 µg/dL,whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

1.015.229.343.560.5

1.115.329.342.656.8

> 62.3 > 62.3

1.0515.2529.3043.0558.65

1.0215.1029.2743.5756.5568.36

171717171611

0.03 µg/dL1.0%0.1%-1.2%3.7%

± 1.00 µg/dL± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%


0 10 20 30 40 50

-100

-50

0

50

100

Perc

ent D

iffer

ence

Peer Mean

◆◆ ◆ ◆

◆◆

◆ ◆ ◆◆



LN5-01 - 06LN5-01 - 05LN5-01 - 04

47.141.2 5.9

5.90.00.0

64.729.4 5.9

0.00.00.0

0.00.00.0




7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityCortisol µg/dL Linearity Evaluation


Goal for Total Error (TE): 25%Mean of Included Results: 29.46 µg/dL

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

1.015.229.343.560.5

1.115.329.342.656.8

> 62.3 > 62.3

1.0515.2529.3043.0558.65

0.8615.1629.4643.7658.06

0.0000.2000.4000.6000.8001.000


0.0 0.2 0.4 0.6 0.8

0

10

20

30

40

50

60

Assa

y Re

sult

µg/d

L


◆

◆

◆

◆

◆

◆

◆

◆

◆

◆


0.0 0.2 0.4 0.6 0.8

-5

0

5

Diffe

renc

e fro

m B

est-f

it Li

ne µ

g/dL


◆ ◆ ◆ ◆

◆

◆ ◆◆

◆ ◆

-TE

-TE/4

TE/4

TE

◆

●






7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityFerritin ng/mL (µg/L) Calibration Verification Evaluation


Allowable Error: 15% or 16.5 ng/mL (µg/L),whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

4.1 370.8 706.3

1167.71689.41947.0

3.7 374.2 759.21141.81679.82006.2

3.90 372.50 732.75

1154.751684.601976.60

3.26 356.45 709.88

1127.971600.881871.80

116118118118118 90

0.64 ng/mL4.5%3.2%2.4%5.2%5.6%

± 16.50 ng/mL± 15.0%± 15.0%± 15.0%± 15.0%± 15.0%


** Diluted specimen


0 500 1000 1500

-60

-40

-20

0

20

40

60

Perc

ent D

iffer

ence


◆

◆

◆

◆◆ ◆

◆

◆◆

◆◆

◆◆◆

◆

◆

Not DilutedDiluted



LN5-01 - 06LN5-01 - 05LN5-02 - 06LN5-01 - 04

66.122.0 0.8 3.4

6.80.00.80.0

56.818.6 1.718.6

0.00.80.00.0

0.02.50.00.8




7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityFerritin ng/mL (µg/L) Linearity Evaluation



Evaluation Type: Diluted/ExtendedGoal for Total Error (TE): 30% (25% for Linearity)

Mean of Included Results: 789.70 ng/mL (µg/L)

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

4.1 370.8 706.3

1167.71689.41947.0

3.7 374.2 759.2

1141.81679.82006.2

3.90 372.50 732.75

1154.751684.601976.60

< 0 375.33 789.70

1204.071618.432032.80

0.0000.2000.4000.6000.8001.000*

* Diluted specimen


0.0 0.2 0.4 0.6 0.8 1.0

0

500

1000

1500

2000

Assa

y Re

sult

ng/m

L (µ

g/L)


◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

●●●●


0.0 0.2 0.4 0.6 0.8 1.0

-400

-200

020

040

0

◆

◆

◆

◆

◆◆

◆◆

◆

◆

●

●

●

●


Diffe

renc

e fro

m B

est-f

it Li

ne n

g/m

L (µ

g/L)


◆

●

◆

●





Best-fitTarget




Included in linear rangeLN5-06 59.2 1976.60 2032.80 -56.20 ± 254.10




7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityFolate ng/mL Calibration Verification Evaluation

Evaluation Result: DifferentPeer Method: BECKMAN ACCESS/2

Allowable Error: 15% or 0.3 ng/mL,whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

0.481.582.693.524.785.83

0.001.372.633.644.895.87

0.2401.4752.6603.5804.8355.850

0.806 4.021 7.028 9.476

12.44314.846

272929292929

-0.566 ng/mL-63.3%-62.2%-62.2%-61.1%-60.6%

± 0.300 ng/mL± 15.0%± 15.0%± 15.0%± 15.0%± 15.0%


2 4 6 8 10 12 14

-100

-50

0

50

Perc

ent D

iffer

ence

Peer Mean

◆

◆ ◆ ◆ ◆ ◆

◆

◆◆ ◆ ◆ ◆



LN5-01 - 06LN5-02 - 06LN5-01 - 04

58.620.7 0.0

17.2 3.4 0.0

89.7 6.9 3.4

0.00.00.0

0.00.00.0




7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityFolate ng/mL Linearity Evaluation


Goal for Total Error (TE): 30% (25% for Linearity)Mean of Included Results: 3.107 ng/mL

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

0.481.582.693.524.785.83

0.001.372.633.644.895.87

0.2401.4752.6603.5804.8355.850

0.3171.4332.5493.6654.7805.896

0.0000.2000.4000.6000.8001.000


0.0 0.2 0.4 0.6 0.8 1.0

0

1

2

3

4

5

6

Assa

y Re

sult

ng/m

L


◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

◆


0.0 0.2 0.4 0.6 0.8 1.0

-0.5

0.0

0.5

Diffe

renc

e fro

m B

est-f

it Li

ne n

g/m

L


◆ ◆ ◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

-TE

-TE/4

TE/4

TE

◆

●






7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityhCG mIU/mL (IU/L) Calibration Verification Evaluation


Allowable Error: 12.5% or 12 mIU/mL (IU/L),whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06LN5-07LN5-08

9.6 152.3 282.3 418.8 543.6 684.5

3408.96056.6

9.0 157.3 287.3 421.6 554.4 703.4

3474.66235.1

9.30 154.80 284.80 420.20 549.00 693.953441.756145.85

7.74 144.28 279.39 413.48 545.75 678.69

3392.386117.43

115115115115115115115115

1.56 mIU/mL7.3%1.9%1.6%0.6%2.2%1.5%0.5%

± 12.00 mIU/mL± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%



0 1000 2000 3000 4000 5000 6000

-40

-20

0

20

40

Perc

ent D

iffer

ence


◆

◆

◆◆◆◆ ◆

◆

◆

◆

◆◆◆◆ ◆ ◆



LN5-01 - 08LN5-01 - 06LN5-01 - 04

96.5 0.9 1.7

0.90.00.0

*LN5-07 and LN5-08 are not evaluated for linearity

*99.1 0.9

*0.00.0

*0.00.0




7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityhCG mIU/mL (IU/L) Linearity Evaluation


Goal for Total Error (TE): 25%Mean of Included Results: 352.01 mIU/mL (IU/L)

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06LN5-07LN5-08

9.6 152.3 282.3 418.8 543.6 684.5

3408.96056.6

9.0 157.3 287.3 421.6 554.4 703.4

3474.66235.1

9.30 154.80 284.80 420.20 549.00 693.95

3441.756145.85

13.35148.81284.28419.74555.20690.67

0.0000.2000.4000.6000.8001.000

§ Not evaluated for linearity.

§§


0.0 0.2 0.4 0.6 0.8 1.0

0

200

400

600

Assa

y Re

sult

mIU

/mL

(IU/L

)


◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

◆


0.0 0.2 0.4 0.6 0.8 1.0

-50

0

50

Diffe

renc

e fro

m B

est-f

it Li

ne m

IU/m

L (IU

/L)


◆

◆◆ ◆

◆◆◆

◆◆ ◆

◆

◆

-TE

-TE/4

TE/4

TE


◆

●





7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityTriiodothyronine T3 ng/dL Calibration Verification Evaluation

Evaluation Result: Verified from 50.40 to 532.45 Peer Method: ABBOTT ARCHITECT i

Allowable Error: 12.5% or 20 ng/dL,whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

49.5 250.4 397.4 557.7 920.8

1155.1

51.3 253.7 393.7 507.2 943.61331.3

50.40 252.05 395.55 532.45 932.20

1243.20

52.88271.94448.21586.74725.82784.40

646464503835

-2.48 ng/dL-7.3%

-11.7%-9.3%28.4%58.5%

± 20.00 ng/dL± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%

**

* Diluted specimen


200 400 600 800

-40

-20

0

20

40

60

Perc

ent D

iffer

ence

Peer Mean

◆ ◆◆

◆

◆

◆

◆◆

◆ ◆

◆

◆

◆

◆

◆

◆

◆

◆

Not DilutedDiluted



LN5-01 - 06LN5-01 - 05LN5-01 - 04

Other

18.8 4.712.515.6

29.7 1.610.9 6.3

30.014.010.0 0.0

8.04.08.00.0

8.0 0.018.0 0.0




7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityTriiodothyronine T3 ng/dL Linearity Evaluation

Method: ABBOTT ARCHITECT iEvaluation Result: Linear from 50.40 to 532.45 Evaluation Type: Diluted/Extended

Goal for Total Error (TE): 25%Mean of Included Results: 307.61 ng/dL

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

49.5 250.4 397.4 557.7 920.8

1155.1

51.3 253.7 393.7 507.2 943.6

1331.3

50.40 252.05 395.55 532.45 932.20

1243.20

69.16228.13387.10546.06705.03863.99

0.0000.2000.4000.6000.8001.000

**

* Diluted specimen


0.0 0.2 0.4 0.6 0.8 1.0

0

200

400

600

800

1000

1200

Assa

y Re

sult

ng/d

L


◆

◆

◆

◆

◆

◆

◆

◆

●

●

●

●

●

●

●

●


0.0 0.2 0.4 0.6 0.8 1.0

-400

-200

020

040

0

◆

◆ ◆ ◆◆

◆◆

◆

●

●

●

●

●

●

●

●


Diffe

renc

e fro

m B

est-f

it Li

ne n

g/dL


◆

●

◆

●





Best-fitTarget




Excluded: Diff. exceeds allowable errorLN5-05 22.8 932.20 705.03 227.17 ± 88.13Not evaluated: Previous spec. excludedLN5-06 176.2 1243.20 863.99 ----- -----




7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityThyroxine (Total) T4 µg/dL Calibration Verification Evaluation


Allowable Error: 10% or 0.5 µg/dL,whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06LN5-07

1.0 6.0

12.519.820.125.4

1.1 5.9

13.020.021.026.6

> 48.0 > 48.0

1.05 5.95

12.7519.9020.5526.00

1.30 6.14

13.2320.1122.1827.1986.09

537272705441 9

-0.25 µg/dL-3.1%-3.6%-1.0%-7.3%-4.4%

± 0.50 µg/dL± 10.0%± 10.0%± 10.0%± 10.0%± 10.0%± 10.0%

**

* Diluted specimen


5 10 15 20 25

-40

-20

0

20

40

Perc

ent D

iffer

ence

Peer Mean

◆

◆

◆

◆

◆

◆

◆

◆◆

◆

◆

◆

◆◆

◆◆

◆

◆

Not DilutedDiluted


Calibration Verification Linearity Evaluation

Range % Verified % Different % Linear % Nonlinear % ImpreciseLN5-01 - 07LN5-01 - 06LN5-02 - 07LN5-01 - 05LN5-02 - 06LN5-01 - 04LN5-02 - 05

Other

1.416.7 2.8

18.1 4.2

19.411.1 5.6

0.08.30.02.82.82.81.42.8


*10.6

* 4.5 3.0

24.212.1 0.0

*1.5

*6.11.57.60.00.0

* 6.1

* 0.0 3.0

16.7 3.0 0.0




7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityThyroxine (Total) T4 µg/dL Linearity Evaluation

Method: ABBOTT ARCHITECT iEvaluation Result: Linear from 1.05 to 19.90 Evaluation Type: Diluted/Extended

Goal for Total Error (TE): 20%Mean of Included Results: 9.91 µg/dL

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06LN5-07

1.0 6.0

12.519.820.125.4

1.1 5.9

13.020.021.026.6

> 48.0 > 48.0

1.05 5.9512.7519.9020.5526.00

0.41 6.74

13.0819.4225.7532.09

0.0000.2000.4000.6000.8001.000

**

* Diluted specimen


0.0 0.2 0.4 0.6 0.8 1.0

0

5

10

15

20

25

30

Assa

y Re

sult

µg/d

L


◆

◆

◆

◆

◆

◆

◆

◆ ●

●

●

●

●

●

●

●


0.0 0.2 0.4 0.6 0.8 1.0

-6-4

-20

24

6

◆

◆ ◆

◆◆

◆

◆

◆

●

●

●

●●

●

●

●


Diffe

renc

e fro

m B

est-f

it Li

ne µ

g/dL


◆

●

◆

●





Best-fitTarget



1 Limit for replicate difference = 6.7% of Best-fit Target2 Allowable Error = 10% of Best-fit Target

Excluded: Diff. exceeds allowable errorLN5-05 0.9 20.55 25.75 -5.20 ± 2.58Not evaluated: Previous spec. excludedLN5-06 1.2 26.00 32.09 ----- -----




7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityTSH µIU/mL (mIU/L) Calibration Verification Evaluation


Allowable Error: 12.5% or 1 µIU/mL (mIU/L),whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

0.02317.88133.52953.05169.54785.978

0.02316.76134.03851.15568.18188.270

0.023017.321033.783552.103068.864087.1240

0.025518.829836.997255.752774.940292.3876

137138138138138126

-0.0025 µIU/mL-8.0%-8.7%-6.5%-8.1%-5.7%

± 1.0000 µIU/mL± 12.5%± 12.5%± 12.5%± 12.5%± 12.5%

Note: µIU/mL is equivalent to mIU/L.


0 20 40 60 80

-40

-20

0

20

40

Perc

ent D

iffer

ence


◆◆

◆

◆◆ ◆

◆

◆◆ ◆ ◆

◆



LN5-01 - 06LN5-01 - 05LN5-01 - 04LN5-02 - 05

84.1 8.7 4.3 0.7

2.20.00.00.0

91.3 8.0 0.0 0.7

0.00.00.00.0

0.00.00.00.0




7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityTSH µIU/mL (mIU/L) Linearity Evaluation


Goal for Total Error (TE): 25%Mean of Included Results: 43.2031 µIU/mL (mIU/L)

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

0.02317.88133.52953.05169.54785.978

0.02316.76134.03851.15568.18188.270

0.023017.321033.783552.103068.864087.1240

< 017.126534.510951.895369.279786.6640

0.0000.2000.4000.6000.8001.000


0.0 0.2 0.4 0.6 0.8 1.0

0

20

40

60

80

Assa

y Re

sult

µIU/

mL

(mIU

/L)


◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

◆

◆


0.0 0.2 0.4 0.6 0.8 1.0

-10

-5

0

5

10

Diffe

renc

e fro

m B

est-f

it Li

ne µ

IU/m

L (m

IU/L

)


◆◆

◆

◆

◆

◆

◆◆ ◆ ◆

◆

◆

-TE

-TE/4

TE/4

TE

◆

●





7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityVitamin B-12 pg/mL Calibration Verification Evaluation


Allowable Error: 15% or 30 pg/mL,whichever is greater

Specimen Assay1

Assay2

YourMean

PeerMean

PeerN


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

83 412 803

1263

90 442 856

1380> 1500> 1500

> 1500> 1500

86.5 427.0 829.5

1321.5

78.7 436.0 849.5

1252.31509.12064.1

2929292814 9

7.8 pg/mL-2.1%-2.4%5.5%

± 30.0 pg/mL± 15.0%± 15.0%± 15.0%± 15.0%± 15.0%


200 400 600 800 1000 1200

-60

-40

-20

0

20

40

60

Perc

ent D

iffer

ence

Peer Mean

◆

◆ ◆

◆

◆

◆ ◆

◆



LN5-01 - 06LN5-01 - 05LN5-01 - 04

Other

20.720.748.3 3.4

3.40.03.40.0

10.721.457.1 0.0

0.00.00.00.0

0.0 0.010.7 0.0




7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/LinearityVitamin B-12 pg/mL Linearity Evaluation

Method: BECKMAN ACCESS/2Evaluation Result: Imprecise (Poor Repeatability and/or Fit) Evaluation Type: Standard

Goal for Total Error (TE): 30% (25% for Linearity)Mean of Included Results: 666.1 pg/mL

Specimen Assay1

Assay2

YourMean

Best-fitTarget


LN5-01LN5-02LN5-03LN5-04LN5-05LN5-06

83 412 803

1263

90 442 856

1380> 1500> 1500

> 1500> 1500

86.5 427.0 829.5

1321.5

50.0 460.7 871.5

1282.2

0.0000.2000.4000.6000.8001.000


0.0 0.1 0.2 0.3 0.4 0.5 0.6

0

200

400

600

800

1000

1200

1400

Assa

y Re

sult

pg/m

L


◆

◆

◆

◆

◆

◆

◆

◆


0.0 0.1 0.2 0.3 0.4 0.5 0.6

-100

0

100

Diffe

renc

e fro

m B

est-f

it Li

ne p

g/m

L


◆

◆

◆

◆

◆

◆ ◆

◆

-TE

-TE/4

TE/4

TE

◆

●





7181660-01 01 28017117Kit ID:Kit Mailed:

Next Mailing Date:


06/01/201507/15/201511/23/2015



LN5-A 2015 Ligand Calibration Verification/Linearity Vitamin B-12 pg/mL Linearity Troubleshooting Report

Evaluation Result: Imprecise (Poor Repeatability and/or Fit)

Interpretation: Your results have large differences between assay replicates; one set of assays is consistently greater than the other set. Suggested Actions: Check your testing procedure. Both assays from each vial should be tested within the same run. Review specimen handling procedures. Incomplete thawing, inadequate mixing, or improper temperatures can cause problems. Check for evidence of test system malfunction. Pipetting errors, temperature fluctuations, or optical system problems can contribute to large analytical errors. If unable to resolve, contact your method manufacturer.

Troubleshooting Report Plot: Differenceswith Allowable Error Limits

0.0 0.1 0.2 0.3 0.4 0.5 0.6

-200

-100

0

100

200

Diffe

renc

e fro

m B

est-f

it Li

ne p

g/m

L


◆

◆

◆

◆

◆

◆ ◆

◆

-TE

-TE/4

TE/4

TE

Document investigation and corrective action here or on the CVL Investigation Checklist: Reviewed by: Date:

original evaluation bnp5-c 2015 b-type natriuretic ... · original evaluation bnp5-c 2015 b-type...

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