nsqap 2016 quality control program report screening quality assurance program volume 27, no.2 2016...

Newborn Screening Quality Assurance Program Volume 27, No.2

2016 Quality Control Program Report

2016 Set 2 July—October Issued: February 2017

Introduction

The NSQAP Quality Control (QC) dried blood spot materials provide participants with external controls to assess

method performance over a longer time interval compared with Proficiency Testing (PT) which is an assessment

of assay performance at one point in time. These controls provide continuity and transcend changes in produc-

tion lots of routinely used method- or kit-control materials. The external QC materials are intended to supplement

the participants’ method- or kit-control materials at periodic intervals and to allow participants to monitor the long

-term stability of their assays. NSQAP QC materials should not be considered a replacement for manufacturer

kit controls or other routine daily QC. This 2016 Set 2 report contains a summary of the QC data submitted

during the second half of 2016 by state, contract, and private laboratories in the United States; international

participants; and manufacturers of screening test products.

QC Material Production

Dried blood spot (DBS) QC lots were prepared from whole blood of 50% hematocrit. The materials were en-

riched with predetermined quantities of selected analytes and dispensed in 100 μL aliquots on GE

Healthcare Bio-Sciences Corporation (Westborough, MA) Grade 903 filter paper. The QC specimen lots were

provided as 6-month supplies of DBSs on filter paper.

The QC shipment for Thyroxine (T4), Thyroid-Stimulating Hormone (TSH), 17α-Hydroxyprogesterone

(17O H P) ,Galactose-1-phosphate Uridyltransferase (GALT), and the analytes 24:0- and 26:0-

Lysophosphatidylcholine ( 2 4 L P C a n d 2 6 L P C ) f o r t h e d e t e c t i o n o f X-linked Adrenoleu-

kodystrophy (XALD) consisted of blood spot materials from three lots per analyte, with each lot containing a

different concentration of analyte. The shipment for Immunoreactive Trypsinogen (IRT), Total Galactose

(TGal), Phenylalanine (Phe), Leucine (Leu), Methionine (Met), Tyrosine (Tyr), Valine (Val), Citrulline (Cit), Ala-

nine (Ala), Arginine (Arg), Succinylacetone (SUAC), F r e e c a r n i t i n e (C0), A c e t y l c a r n i t i n e ( C2),

P r op i o n y l c a r n i t i ne ( C3), Ma l on y l c a r n i t i ne ( C3DC), Butyrylcarnitine (C4), H yd r o x ybu t y r y l -

c a r n i t i n e ( C4OH), Isovalerylcarnitine (C5), Glutarylcarnitine (C5DC), 3-Hydroxyisovalerylcarnitine (C5OH),

Hexanoylcarnitine (C6), Octanoylcarnitine (C8), Decanoylcarnitine (C10), Dodecanoylcarnitine (C12),

Myristoylcarnitine (C14), Palmitoylcarnitine (C16), 3-Hydroxypalmitoylcarnitine (C16OH), Stearoylcarnitine

(C18), and Hydroxystearoylcarnitine (C18OH) consisted of blood spot cards from four lots.

NSQAP also distributed certified QC materials for newborn screening analytes and disorders designed for labor-

atories conducting second-tier testing by tandem mass spectrometry (MS/MS). These programs include Second

–tier Congenital Adrenal Hyperplasia (CAHQC) by LC-MS/MS for the analytes 17-

Hydroxyprogesterone (17OHP2), 4-Androstenedione (4AD2), Cortisol (CORT2), 11-Deoxycortisol (11D2), and

21-Deoxycortisol (21D2); Second-tier Maple Syrup Urine Disease and Phenylketonuria (MSUD-PKUQC) by LC-

MS/MS for the analytes Alloisoleucine (ALE2), Isoleucine (ILE2), Leucine (LEU2), Phenylalanine (PHE2), Tyro-

sine (TYR2), and Valine (VAL2); Second-tier Methylmalonic/Propionic Acidemia and Homocystinuria (MMA-

tHCY) by LC-MS/MS for the analytes Methylmalonic Acid (MMA2), Ethylmalonic Acid (EMA2), 2-Methylcitric Acid

(MCA2), and Total Homocysteine (tHCY2); and Guanidinoacetate Methyltransferase (GAMT) by FIA-MS/MS for

the analytes Guanidinoacetic Acid (GAA2), and Creatine (CRE2).

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QC Material Distribution

On July 11, 2016 we distributed DBS QC materials for T4, TSH 17OHP, TGal, GALT, IRT, amino acids (Phe,

Leu, Met, Tyr, Val, Cit, Ala, Arg), SUAC, acylcarnitines (C0, C2, C3, C3DC, C4, C4OH, C5, C5DC, C5OH, C6,

C8, C10, C12, C14, C16, C16OH, C18, C18OH), and XALD.

QC Data Reporting Requirements

All participants were notified to access the QC Data Report forms and detailed instructions from our website

at: https://www.cdc.gov/labstandards/nsqap_resources.html NSQAP requires the following information for

each QC analyte data submission; 1) laboratory information (contact name, laboratory code number, email),

2) analyte kit or method, 3) results of duplicate sample analysis from five independent runs in the analytic

units and decimal places requested, and 4) at least nine data points for each lot level of analyte. If these mini-

mum requirements were not met, the data was not accepted unless the participant corrected their submis-

sion.

Participant Results

We compiled the Set 2 data and calculated mean values and standard deviations. Data values outside the

99% confidence interval for each QC lot were not included in the computations. For linear regression analy-

sis, we could not include qualitative data, data submitted as inequalities or ranges, data submitted in unidenti-

fied units, or data from less than five analytic runs per QC lot per analyte.

Several participants were required to resubmit their data because either the method was not entered from

the drop-down menu or data was reported in the incorrect units. To ensure that all results are appropriately

entered in the CDC database, participants must convert their results to the requested units before entering

them on the data report forms. For GALT analysis, where no conversion factor exists between enrichment

value units U/g Hb and other reportable units, we included a separate table to provide participants with peer-

group statistics.

The reported QC data summaries show the analyte by QC lot series, the number of measurements (N), the

mean values, and the standard deviations (SD) by kit or analytic method. In addition, we used a weighted

linear regression analysis to examine the comparability by method of reported (aggregated) versus enriched

concentrations. Results of the linear regression analyses are summarized in the tables on pages 4—57.

Discussion

The enriched values of the QC specimen lots do not take into account the endogenous levels of the ana-

lytes. For Phe, Leu, Met, Tyr, Val, Cit, Ala, Arg, SUAC, acylcarnitines, 24:0- and 26:0-

Lysophosphatidylcholine, a n d a l l S e c o n d - t i e r a na l y t e s , t h e non-enriched base pools were dis-

tributed as the first QC specimen lot in each series so that participants could measure the endogenous

concentration of the series.

The QC results show method-related differences in analytic recoveries and method bias. Because we pre-

pared each QC lot series from a single batch of hematocrit-adjusted, non-enriched blood, the endogenous

concentration was the same for all specimens across the lot series and should not affect the slope of the

regression line among methods. Slope deviations may be related to analytic ranges for calibration curves.

Generally, slope values substantially different from 1.0 indicate that a method has an analytic bias.

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https://www.cdc.gov/labstandards/nsqap_resources.html

Discussion (cont.)

For analytes measured by MSMS, calculations of concentrations for the QC lots may vary with type of in-

ternal standard. Data are not sorted by internal standard type. Because only three to five concentrations

of QC materials are available for each analyte, a bias error in any one pool can influence the slope and

intercept.

For the purpose of our assessment, we first calculated the within-laboratory SD component of the total SD

and used the reported QC data from multiple analytic runs for regression analyses. We then calculated the

Y-intercept and slope using the analyte concentrations within a lot series (e.g., lots 1551, 1552, and

1553). The Y-intercept provides one measure of the endogenous concentration level for an analyte. For

Phe, Leu, Met, Tyr, Val, Cit, Ala, Arg, SUAC, acylcarnitines, 24:0- and 26:0-Lysophosphatidylcholine, and

a l l Se c ond - t i e r a na l y t e s , p a r t i c i p an t s measured the endogenous concentration levels by ana-

lyzing the non-enriched QC lots. Ideally, the slope should be 1.0, with an acceptable range from 0.8 to

1.2.

The majority of analytes demonstrated acceptable performance, with slopes falling near or within the

range of acceptability. For C0, slopes that were slight ly increased for 2016 Set 1 showed sig-

nif icant improvement in all methods with a new lot number of materials. C4 also showed

improvement with a sl ight increase in s lopes in al l methods. Slope tracking proved to be

useful in identifying method testing discrepancies. Second - t ier QC data analysis for MSUD

showed a signif icant increase in s lope for the f low - inject ion analysis, Non -der ivat ized - MS/

MS PE NeoBase Kit method. For future QC events, only methods that include resolut ion of

isomers wil l be accepted ( i.e. LC -MS/MS).

The next set of QC materials will be shipped on July 10, 2017. Any changes in QC enrollment including addi-

tion or deletion of analyte programs should be submitted to NSQAP no later than May 1, 2017. Download the

Request Participation Form at: http://www.cdc.gov/labstandards/pdf/nsqap/nsqap_requestparticipation.pdf to

request program enrollment changes and send it to NSQAPDMT@ cdc.gov. Include your laboratory code

number on the form and all correspondence with NSQAP.

NEWBORN SCREENING QUALITY ASSURANCE PROGRAM

Editors

Joanne Mei

Irene Williams

�enters for Disease �ontrol and Prevention

4770 �uford Highway NE, MS/F19

!tlanta, G! 30341-3724

Phone: 404-488-7945 Email: jvm0@cdc;gov

This program is co-sponsored by the Centers for Disease Control and Prevention (CDC) and

The !ssociation of Public Health Laboratories (!PHL)

Direct inquiries to:

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http://www.cdc.gov/labstandards/pdf/nsqap/nsqap_requestparticipation.pdf

mailto:NSQAPDMT@%20cdc.gov

2016 Quality Control Data Summaries of Statistical Analyses

Lot 1551 - Enriched 25 ng/mL serum Average Within Y-

METHOD N Mean Lab SD Total SD Intercept* Slope

Siemens Healthcare Diagnostics 30 30.6 1.7 4.4 8.0 0.9

Neo-Genesis Accuwell 28 29.7 3.2 4.2 -5.2 1.3

Delfia 181 21.1 2.2 4.8 -0.1 0.9

Delfia Neonatal 17-OHP (A024) 78 20.5 2.9 5.6 -1.5 0.8

AutoDelfia 293 24.3 2.5 3.6 -0.1 1.0

AutoDelfia Neonatal 17-OHP (B024) 335 24.0 2.3 3.1 -1.5 1.0

Bio-Rad Quantase 80 27.1 3.8 13.5 2.5 1.0

TecnoSuma UMELISA 40 41.9 4.8 20.7 15.0 1.1

LC-MS/MS 50 26.5 2.6 8.8 1.4 1.0

PerkinElmer GSP Neonatal 377 24.3 1.9 2.5 0.4 0.9

In House 30 24.4 3.7 5.6 -2.3 1.0





Delfia 180 42.8 3.7 8.1 -0.1 0.9


AutoDelfia 290 48.2 4.0 6.7 -0.1 1.0


Bio-Rad Quantase 80 50.0 5.6 18.5 2.5 1.0


LC-MS/MS 50 51.6 4.9 16.8 1.4 1.0


In House 30 48.1 5.7 6.5 -2.3 1.0





Delfia 179 85.2 8.0 16.8 -0.1 0.9


AutoDelfia 284 96.9 8.4 12.7 -0.1 1.0


Bio-Rad Quantase 80 99.2 17.0 37.2 2.5 1.0


LC-MS/MS 50 101.8 8.4 33.1 1.4 1.0


In House 30 101.4 14.9 14.9 -2.3 1.0 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the

regression to the Y-axis.

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THYROXINE (µg/dL serum)

Lot A1600 - Enriched 2 µg/dL serum Average Within Y-



Delfia 70 1.8 0.3 0.4 -0.5 1.1

AutoDelfia 202 1.6 0.3 0.4 -0.6 1.1

Interscientific NeoMAP Multiplex 48 1.4 0.3 0.3 -0.8 1.1

PerkinElmer GSP Neonatal 140 1.4 0.2 0.3 -0.7 1.1

Lot B1600 - Enriched 7 µg/dL serum Average Within Y-



Delfia 80 6.9 0.7 1.1 -0.5 1.1

AutoDelfia 203 7.0 0.6 0.8 -0.6 1.1



Lot C1600 - Enriched 11 µg/dL serum Average Within Y-



Delfia 80 11.4 1.3 1.7 -0.5 1.1

AutoDelfia 206 11.3 1.1 1.4 -0.6 1.1


PerkinElmer GSP Neonatal 184 11.0 1.0 1.0 -0.7 1.1 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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THYROID-STIMULATING HORMONE (µIU/mL serum)

Lot A1601 - Enriched 25 µIU/mL serum Average Within Y-


Siemens Healthcare Diagnostics 19 35.5 1.9 2.0 -5.8 1.6


MP Biomedicals ELISA 20 29.5 5.7 6.0 7.8 0.9

Delfia 480 24.1 2.7 6.0 0.0 1.0

AutoDelfia 865 27.7 2.0 3.0 -0.4 1.1

Labsystems Diagnostics 147 24.6 2.6 5.5 -3.3 1.1

Bio-Rad Quantase 79 20.1 2.2 11.2 1.2 0.8

TecnoSuma UMELISA 40 24.2 2.0 6.8 -1.3 1.0

DiaSorin 78 25.9 2.2 2.6 4.3 0.8



In House 60 30.7 2.6 7.0 6.1 1.0

Lot B1601 - Enriched 40 µIU/mL serum Average Within Y-





Delfia 460 37.9 4.1 9.9 0.0 1.0

AutoDelfia 865 43.2 3.3 4.9 -0.4 1.1


Bio-Rad Quantase 80 30.9 3.5 16.2 1.2 0.8


DiaSorin 80 36.8 4.0 5.2 4.3 0.8



In House 59 44.3 4.1 7.4 6.1 1.0

Lot C1601 - Enriched 80 µIU/mL serum Average Within Y-





Delfia 468 76.4 8.2 19.2 0.0 1.0

AutoDelfia 863 88.1 6.5 9.3 -0.4 1.1


Bio-Rad Quantase 80 61.2 5.6 28.1 1.2 0.8


DiaSorin 79 71.4 7.0 11.5 4.3 0.8



In House 60 83.7 10.3 13.7 6.1 1.0 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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GALACTOSE-1-PHOSPHATE URIDYLTRANSFERASE (U/g Hb)

Lot A1603 - Assayed 1.4 U/g Hb Average Within Y-


PerkinElmer Neonatal Kit 246 1.5 0.3 0.5 0.4 0.8

Astoria-Pacific Neonatal Microplate Reagent Kit U/g Hb 59 0.7 0.1 0.2 -0.8 1.1

Lot B1603 - Assayed 3.3 U/g Hb Average Within Y-



Astoria-Pacific Neonatal Microplate Reagent Kit U/g Hb 59 2.8 0.4 0.5 -0.8 1.1

Lot C1603 - Assayed 7.1 U/g Hb Average Within Y-



Astoria-Pacific Neonatal Microplate Reagent Kit U/g Hb 50 7.0 0.6 0.9 -0.8 1.1 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


METHODS REPORTED IN UNITS OTHER THAN U/g Hb (>3 Participants) AVG ALL

N Mean WITHIN LAB MIN MAX

METHOD LAB SD SD

Lot A1603 Astoria-Pacific 50 Hour Reagent Kit

48 14.0 2.5 3.3 9.0 21.2 (µmol/L blood)

Perkin Elmer GSP Neonatal 70 0.5 0.1 0.7 0.0 1.8

(U/dL blood)

Lot B1603 Astoria-Pacific 50 Hour Reagent Kit

(µmol/L blood) 48 82.9 9.9 14.1 48.4 112.4

Perkin Elmer GSP Neonatal

(U/dL blood) 122 1.0 0.2 0.8 0.1 3.0

Lot C1603 Astoria-Pacific 50 Hour Reagent Kit

(µmol/L blood) 50 234.1 21.8 43.2 152.7 342.2

Perkin Elmer GSP Neonatal

(U/dL blood) 188 6.0 0.5 0.7 3.9 7.9

*Outlier data was removed based on the 99% confidence interval

parameters cannot be calculated for these units of measure. Basic peer-group statistics are provided to assist in self-assessment under

those circumstances.

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IMMUNOREACTIVE TRYPSINOGEN (ng/mL blood)

Lot 1591 - Assayed 20.5 ng/mL blood Average Within Y-



Delfia 199 18.0 1.9 2.9 0.3 0.9

AutoDelfia 707 19.1 1.5 2.0 -0.3 1.0

Bio-Rad Quantase 20 49.6 4.2 25.2 43.5 0.9





Delfia 200 55.6 6.2 8.1 0.3 0.9

AutoDelfia 701 61.5 4.6 5.5 -0.3 1.0

Bio-Rad Quantase 20 104.0 3.9 25.2 43.5 0.9





Delfia 199 108.0 10.3 15.2 0.3 0.9

AutoDelfia 699 121.4 9.1 11.6 -0.3 1.0

Bio-Rad Quantase 20 167.6 9.6 28.0 43.5 0.9





Delfia 194 190.4 18.1 24.4 0.3 0.9

AutoDelfia 706 212.0 15.9 20.3 -0.3 1.0

Bio-Rad Quantase 18 223.1 18.3 37.9 43.5 0.9

PerkinElmer GSP Neonatal 329 212.0 13.0 14.5 -1.5 1.0 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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ALANINE (µmol/L blood)

Lot 1525 - Nonenriched 0 µmol/L blood Average Within Y-


Derivatized - MS/MS non-kit 699 386.4 37.5 103.3 379.0 0.7

Non-derivatized - MS/MS non-kit 120 389.1 38.5 86.5 382.5 0.7

Derivatized - MS/MS PE NeoGram Kit 50 418.0 40.5 83.6 401.6 0.8

Non-derivatized - MS/MS PE NeoBase Kit 564 442.1 30.7 64.4 433.6 0.9

Derivatized - MS/MS Chromsystems MassChrom Kit 146 349.6 25.8 92.2 342.7 0.6

Non-derivatized - MS/MS Chromsystems MassChrom Kit 123 332.6 25.9 72.1 319.4 0.6

Non-derivatized - MS2 Screening Neo (MS-Neo) Siemens 10 397.1 33.6 33.6 385.5 0.7

Lot 1526 - Enriched 200.0 µmol/L blood Average Within Y-


























Non-derivatized - MS2 Screening Neo (MS-Neo) Siemens 10 810.5 74.7 74.7 385.5 0.7 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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ARGININE (µmol/L blood)






































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CITRULLINE (µmol/L blood)






































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LEUCINE (µmol/L blood)






































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METHIONINE (µmol/L blood)






































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PHENYLALANINE (µmol/L blood)



Fluorometric Manual 79 100.4 13.6 21.6 96.3 1.1


Labsystems Diagnostics 127 90.3 10.3 20.8 83.1 1.3

Bio-Rad Quantase 48 97.5 19.2 25.6 93.1 1.0

Interscientific Enzyme 50 73.2 5.3 5.7 79.9 0.9

HPLC 10 81.1 3.0 3.0 77.3 0.9







TecnoSuma UMTEST 30 121.5 20.8 39.0 108.0 1.3







Bio-Rad Quantase 48 195.3 23.4 34.7 93.1 1.0


HPLC 10 165.5 7.7 7.7 77.3 0.9










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PHENYLALANINE (µmol/L blood)






Bio-Rad Quantase 49 289.2 28.0 42.4 93.1 1.0


HPLC 10 257.7 11.2 11.2 77.3 0.9














Bio-Rad Quantase 50 410.1 28.3 57.0 93.1 1.0


HPLC 10 357.0 20.1 20.1 77.3 0.9










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SUCCINYLACETONE (µmol/L blood)
























Derivatized - MS/MS Chromsystems MassChrom Kit 98 6.8 0.8 1.5 0.7 0.4 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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TYROSINE (µmol/L blood)



HPLC 10 96.0 3.1 3.1 90.9 0.9










HPLC 10 262.6 10.3 10.3 90.9 0.9










HPLC 10 442.4 17.2 17.2 90.9 0.9










HPLC 10 627.8 37.1 37.1 90.9 0.9









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VALINE (µmol/L blood)






































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TOTAL GALACTOSE (mg/dL blood)

Lot 1525 - Enriched 5.0 mg/dL blood Average Within Y-


Siemens Healthcare Diagnostics 40 5.3 0.3 0.3 1.4 0.8 Fluorometric Manual 97 5.2 0.6 0.9 0.1 1.0 Colorimetric 90 6.7 0.9 2.8 -0.3 1.3 PerkinElmer Neonatal Kit 221 4.8 0.5 1.0 1.0 0.8 Neo-Genesis Accuwell 30 5.8 0.4 0.5 0.1 1.1 Bio-Rad Quantase 154 6.6 0.9 1.6 -1.2 1.5 Interscientific Enzyme 39 5.6 0.6 0.7 1.5 0.8 PerkinElmer GSP Neonatal 169 5.5 0.5 0.8 1.0 0.9 Astoria-Pacific 50 Hour Reagent Kit 60 7.1 0.6 1.1 1.8 1.0 TecnoSuma UMTEST 46 6.8 1.2 1.6 -0.3 1.4









Siemens Healthcare Diagnostics 40 25.8 1.4 6.0 1.4 0.8 Fluorometric Manual 98 29.3 2.3 3.5 0.1 1.0 Colorimetric 90 38.6 3.5 16.3 -0.3 1.3 PerkinElmer Neonatal Kit 225 23.9 1.9 3.8 1.0 0.8 Neo-Genesis Accuwell 28 33.5 2.3 2.8 0.1 1.1 Bio-Rad Quantase 158 43.0 4.9 6.9 -1.2 1.5 Interscientific Enzyme 40 25.1 1.7 1.8 1.5 0.8 PerkinElmer GSP Neonatal 169 27.3 2.8 3.6 1.0 0.9 Astoria-Pacific 50 Hour Reagent Kit 60 30.3 1.8 3.8 1.8 1.0 TecnoSuma UMTEST 50 41.2 6.8 10.2 -0.3 1.4 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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FREE CARNITINE (µmol/L blood)

Lot A1606 - Nonenriched 0 µmol/L blood Average Within Y-









Lot B1606 - Enriched 10.0 µmol/L blood Average Within Y-









Lot C1606 - Enriched 20.0 µmol/L blood Average Within Y-









Lot D1606 - Enriched 30.0 µmol/L blood Average Within Y-







Non-derivatized - MS/MS Chromsystems MassChrom Kit 140 37.60 2.45 6.10 10.18 0.9 Non-derivatized - MS2 Screening Neo (MS-Neo) Siemens 40 43.36 1.93 4.93 11.91 1.1 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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ACETYLCARNITINE (µmol/L blood)





































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PROPIONYLCARNITINE (µmol/L blood)





































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MALONYLCARNITINE (µmol/L blood)



















Derivatized - MS/MS PE NeoGram Kit 80 3.38 0.40 0.74 0.05 1.1 Derivatized - MS/MS Chromsystems MassChrom Kit 138 2.07 0.30 0.72 0.03 0.7 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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MALONYLCARNITINE + HYDROXYBUTYRYLCARNITINE (µmol/L blood)












N Mean Lab SD Total SD Intercept* Slope







Non-derivatized - MS/MS PE NeoBase Kit 550 1.71 0.13 0.32 0.03 0.3 Non-derivatized - MS/MS Chromsystems MassChrom Kit 60 2.93 0.23 3.31 0.05 0.5 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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BUTYRYLCARNITINE (µmol/L blood)







Derivatized - MS/MS Chromsystems MassChrom Kit 144 0.07 0.02 0.03 -0.01 0.7


Non-derivatized - MS2 Screening Neo (MS-Neo) Siemens 38 0.08 0.01 0.01 -0.04 0.9


























Non-derivatized - MS/MS Chromsystems MassChrom Kit 136 3.55 0.19 0.46 0.03 0.7 Non-derivatized - MS2 Screening Neo (MS-Neo) Siemens 40 4.61 0.18 0.62 -0.04 0.9 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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HYDROXYBUTYRYLCARNITINE (µmol/L blood)



















Derivatized - MS/MS PE NeoGram Kit 70 1.87 0.24 0.90 0.11 0.7 Derivatized - MS/MS Chromsystems MassChrom Kit 107 1.66 0.19 0.29 0.05 0.6 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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ISOVALERYLCARNITINE (µmol/L blood)





































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GLUTARYLCARNITINE (µmol/L blood)






Non-derivatized - MS/MS PE NeoBase Kit 612 0.03 0.01 0.02 0.02 1































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HYDROXYISOVALERYLCARNITINE (µmol/L blood)





































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HEXANOYLCARNITINE (µmol/L blood)




Non-derivatized - MS/MS non-kit 190 0.01 0.00 0.00 -0.01 0.8































Non-derivatized - MS/MS Chromsystems MassChrom Kit 140 1.87 0.11 0.32 0.00 0.7 Non-derivatized - MS2 Screening Neo (MS-Neo) Siemens 40 1.76 0.10 0.19 -0.01 0.7 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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OCTANOYLCARNITINE (µmol/L blood)






Non-derivatized - MS/MS PE NeoBase Kit 693 0.01 0.00 0.01 -0.01 0.9


Non-derivatized - MS/MS Chromsystems MassChrom Kit 159 0.01 0.00 0.01 -0.01 0.8



























Non-derivatized - MS/MS Chromsystems MassChrom Kit 165 2.03 0.13 0.25 -0.01 0.8 Non-derivatized - MS2 Screening Neo (MS-Neo) Siemens 40 2.84 0.17 0.30 -0.01 1.1 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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DECANOYLCARNITINE (µmol/L blood)





































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DODECANOYLCARNITINE (µmol/L blood)





































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MYRISTOYLCARNITINE (µmol/L blood)





































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PALMITOYLCARNITINE (µmol/L blood)





































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HYDROXYPALMITOYLCARNITINE (µmol/L blood)





































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STEAROYLCARNITINE (µmol/L blood)





































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HYDROXYSTEAROYLCARNITINE (µmol/L blood)































Derivatized - MS/MS Chromsystems MassChrom Kit 129 0.79 0.12 0.37 0.02 0.5 Non-derivatized - MS/MS Chromsystems MassChrom Kit 99 0.66 0.08 0.21 0.00 0.4 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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24:0-LYSOPHOSPHATIDYLCHOLINE (µmol/L blood)



LC-MS/MS 20 0.07 0.01 0.02 0.03 0.8

FIA-MS/MS 20 0.45 0.1 0.29 0.38 1.1



LC-MS/MS 20 0.81 0.07 0.3 0.03 0.8

FIA-MS/MS 20 1.42 0.17 0.31 0.38 1.1



LC-MS/MS 20 4.25 0.51 1.54 0.03 0.8 FIA-MS/MS 20 6.02 0.77 0.77 0.38 1.1 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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26:0 LYSOPHOSPHATIDYLCHOLINE (µmol/L blood)



LC-MS/MS 20 0.03 0.00 0.01 -0.02 0.9

FIA-MS/MS 30 0.23 0.05 0.07 0.19 1.0



LC-MS/MS 19 0.78 0.06 0.14 -0.02 0.9

FIA-MS/MS 28 1.14 0.10 0.10 0.19 1.0



LC-MS/MS 18 4.34 0.44 0.61 -0.02 0.9 FIA-MS/MS 30 5.26 0.48 0.68 0.19 1.0 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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Lot A1611 - Nonenriched 0 ng/mL serum Average Within Y-


LC-MS/MS 98 1.1 0.4 1.6 -1.3 1.1


Lot B1611 - Enriched 10.0 ng/mL serum Average Within Y-


LC-MS/MS 154 11.1 1.2 2.3 -1.3 1.1


Lot C1611 - Enriched 50.0 ng/mL serum Average Within Y-


LC-MS/MS 142 55.2 4.3 9.9 -1.3 1.1


Lot D1611 - Enriched 100.0 ng/mL serum Average Within Y-


LC-MS/MS 159 104.6 10.2 18.7 -1.3 1.1


Lot E1611 - Enriched 500.0 ng/mL serum Average Within Y-


LC-MS/MS 152 551.6 45.2 77.5 -1.3 1.1

Non-derivatized - MS/MS non-kit 10 437.3 37.7 37.7 -1.8 0.9 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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2ND TIER 4-ANDROSTENEDIONE (ng/mL serum)



LC-MS/MS 100 0.6 0.3 0.5 1.0 1.0




LC-MS/MS 151 10.0 0.9 1.8 1.0 1.0




LC-MS/MS 146 56.7 4.4 10.5 1.0 1.0




LC-MS/MS 155 103.3 8.4 20.2 1.0 1.0




LC-MS/MS 151 521.9 38.6 89.9 1.0 1.0

Non-derivatized - MS/MS non-kit 10 434.7 45.3 45.3 -1.7 0.9 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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2ND TIER CORTISOL (ng/mL serum)



LC-MS/MS 127 1.0 0.5 0.9 1.7 1.1




LC-MS/MS 156 11.9 1.5 2.2 1.7 1.1




LC-MS/MS 148 56.7 4.5 8.1 1.7 1.1




LC-MS/MS 159 110.8 8.6 16.2 1.7 1.1




LC-MS/MS 158 543.2 39.5 65.3 1.7 1.1

Non-derivatized - MS/MS non-kit 10 425.3 45.7 45.7 1.9 0.9 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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2ND TIER 11-DEOXYCORTISOL (ng/mL serum)



LC-MS/MS 60 0.6 0.3 0.9 4.8 1.0



LC-MS/MS 87 12.3 1.3 2.4 4.8 1.0



LC-MS/MS 89 56.3 3.8 9.6 4.8 1.0



LC-MS/MS 89 108.2 9.5 21.4 4.8 1.0



LC-MS/MS 88 499.0 51.5 141.1 4.8 1.0 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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2ND TIER 21-DEOXYCORTISOL (ng/mL serum)



LC-MS/MS 49 0.3 0.3 0.4 0.4 1.0



LC-MS/MS 78 10.6 1.3 2.7 0.4 1.0



LC-MS/MS 77 53.8 4.2 11.2 0.4 1.0



LC-MS/MS 80 103.5 8.3 25.4 0.4 1.0



LC-MS/MS 78 522.1 44.9 112.3 0.4 1.0 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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2ND TIER ALLOISOLEUCINE (µmol/L blood)



LC-MS/MS 53 0.6 0.2 0.6 2.5 0.8




LC-MS/MS 89 86.4 6.6 20.2 2.5 0.8




LC-MS/MS 86 174.2 12.1 40.9 2.5 0.8




LC-MS/MS 84 328.9 24.3 65.9 2.5 0.8


Lot E1613 - Enriched 800.0 µmol/L blood Average Within Y-


LC-MS/MS 88 670.5 39.7 118.3 2.5 0.8

Derivatized - MS/MS non-kit 30 649.4 43.7 154.3 6.4 0.8 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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2ND TIER ISOLEUCINE (µmol/L blood)



LC-MS/MS 86 25.3 2.6 5.3 31.6 0.8




LC-MS/MS 90 108.4 8.4 16.5 31.6 0.8




LC-MS/MS 90 195.2 16.2 36.6 31.6 0.8




LC-MS/MS 89 356.6 27.4 54.7 31.6 0.8




LC-MS/MS 90 659.7 52.0 113.4 31.6 0.8



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2ND TIER LEUCINE (µmol/L blood)



LC-MS/MS 84 125.4 11.0 41.7 127.0 0.9




LC-MS/MS 86 218.4 16.2 65.6 127.0 0.9




LC-MS/MS 87 321.4 23.8 108.8 127.0 0.9




LC-MS/MS 83 487.7 60.3 127.7 127.0 0.9




LC-MS/MS 90 869.4 70.3 260.6 127.0 0.9



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2ND TIER PHENYLALANINE (µmol/L blood)



LC-MS/MS 40 45.3 1.6 5.0 48.5 0.7






LC-MS/MS 40 122.1 6.2 10.3 48.5 0.7






LC-MS/MS 40 197.8 12.3 21.5 48.5 0.7






LC-MS/MS 40 344.2 14.2 28.8 48.5 0.7






LC-MS/MS 40 633.9 37.0 61.9 48.5 0.7



Non-derivatized - MS/MS PE NeoBase Kit 10 679.4 28.7 28.7 50.9 0.8 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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2ND TIER TYROSINE (µmol/L blood)



LC-MS/MS 40 36.1 2.1 9.0 39.7 0.7






LC-MS/MS 40 111.8 6.4 24.8 39.7 0.7






LC-MS/MS 40 185.0 9.0 47.4 39.7 0.7






LC-MS/MS 40 342.9 17.6 65.5 39.7 0.7






LC-MS/MS 40 620.4 47.1 148.0 39.7 0.7





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2ND TIER VALINE (µmol/L blood)



LC-MS/MS 80 109.8 10.3 28.3 111.3 0.8





LC-MS/MS 80 185.7 20.0 40.4 111.3 0.8





LC-MS/MS 80 269.9 21.1 66.4 111.3 0.8





LC-MS/MS 79 416.8 31.4 100.1 111.3 0.8





LC-MS/MS 80 723.7 51.3 169.1 111.3 0.8




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2ND TIER METHYLMALONIC ACID (µmol/L blood)



LC-MS/MS 70 0.67 0.37 0.62 0.52 0.9





LC-MS/MS 92 4.97 0.68 1.11 0.52 0.9





LC-MS/MS 98 9.15 0.99 2.05 0.52 0.9





LC-MS/MS 98 22.78 2.36 3.78 0.52 0.9





LC-MS/MS 100 44.8 3.9 7.1 0.5 0.9

Derivatized - MS/MS non-kit 20 40.8 2.6 5.2 0.4 0.8 Non-derivatized - MS/MS non-kit 19 43.1 4.3 6.0 0.2 0.9 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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2ND TIER ETHYLMALONIC ACID (µmol/L blood)



LC-MS/MS 38 0.34 0.20 0.30 0.05 1.1





LC-MS/MS 39 6.04 0.49 2.62 0.05 1.1





LC-MS/MS 40 11.54 1.42 5.21 0.05 1.1





LC-MS/MS 39 26.88 2.64 11.49 0.05 1.1





LC-MS/MS 40 57.22 5.16 26.39 0.05 1.1 Non-derivatized - MS/MS non-kit 10 48.83 5.18 5.18 0.37 1.0 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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2ND TIER 2-METHYLCITRIC ACID (µmol/L blood)



LC-MS/MS 46 0.26 0.19 0.22 0.00 1.7





LC-MS/MS 48 4.23 0.62 0.86 0.00 1.7





LC-MS/MS 50 8.30 1.03 1.39 0.00 1.7





LC-MS/MS 50 20.28 2.76 3.85 0.00 1.7





LC-MS/MS 50 41.93 4.50 7.37 0.00 1.7 Non-derivatized - MS/MS non-kit 20 29.94 4.70 15.04 -0.05 1.2 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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2ND TIER TOTAL HOMOCYSTEINE (µmol/L blood)



LC-MS/MS 60 10.21 1.40 3.38 10.45 1.2





LC-MS/MS 60 16.80 1.99 4.11 10.45 1.2





LC-MS/MS 58 22.62 2.67 4.41 10.45 1.2





LC-MS/MS 60 39.80 3.48 5.14 10.45 1.2





LC-MS/MS 60 70.43 6.67 10.46 10.45 1.2

Derivatized - MS/MS non-kit 10 53.18 4.58 4.58 7.88 0.9 Non-derivatized - MS/MS non-kit 30 38.45 3.61 14.10 5.91 0.7 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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GUANIDINOACETIC ACID (µmol/L blood)



LC-MS/MS 20 3.8 0.7 0.7 3.3 2.2




LC-MS/MS 20 8.4 0.7 0.7 3.3 2.2


Lot C1512 - Enriched 5 µmol/L blood Average Within Y-


LC-MS/MS 20 14.4 1.3 1.3 3.3 2.2




LC-MS/MS 20 19.4 1.9 1.9 3.3 2.2


Lot E1512 - Enriched 10 µmol/L blood Average Within Y-


LC-MS/MS 20 25.8 2.1 2.1 3.3 2.2 Derivatized - MS/MS non-kit 78 11.9 1.4 3.4 2.9 0.9 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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CREATINE (µmol/L blood)















LC-MS/MS 10 484.4 85.0 85.0 484.4 0.0 Derivatized - MS/MS non-kit 70 667.3 63.3 271.9 267.8 0.9 *Estimated by performing a weighted linear regression analysis of mean reported concentrations versus enriched concentrations and extrapolating the


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nsqap 2016 quality control program report screening quality assurance program volume 27, no.2 2016...

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