Biochemical Analysis Plan

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Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport, Portsmouth, NH (The Pease Study)

Biochemical Analysis Plan

OMB: 0923-0061

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Attachment 3. Biochemical Analytical Plan in Children and Adults.


Biochemical analytical plan in children and adults: performing laboratories, reference levels, reporting ranges, clinical guidelines, and critical values.

Laboratory and Contact

Analyte

* CLIA Cert.

Matrix

Volume

NHANES 1

(µg/L)

2013 - 2014

Children and Adults

NCEH/Division of Laboratory Sciences*

Contact: Dr. Antonia Calafat

Per- and Poly-fluoroalkyl Substances (PFAS)

Yes

Serum

1 ml (for all PFAS);

1 ml reserve (for future PFAS analyses)

Age Group (years):

50th to 95th %

perfluorooctanoic acid (PFOA)‡

3-5:

6-11:

12-19:

20+:

1.80 – 5.58

1.94 – 3.84

1.67 – 3.47

2.07 – 5.60

n-PFOA - linear isomer

3-5:

6-11:

12-19:

20+:

1.72 – 5.32

1.84 – 3.77

1.60 – 3.40

2.00 – 5.40

Sb-PFOA - serum branched isomer

3-5:

6-11:

12-19:

20+:

< LOD – 0.280

< LOD – 0.230

< LOD – 0.200

< LOD – 0.200

perfluorooctane sulfonic acid, (PFOS)‡

3-5:

6-11:

12-19:

20+:

3.41 – 8.82

4.02 – 12.4

3.60 – 9.30

5.60 – 19.5

n-PFOS – linear isomer

3-5:

6-11:

12-19:

20+:

2.11 – 6.19

2.65 – 8.41

2.70 – 7.10

3.70 – 15.1

Sm-PFOS – serum branched

3-5:

6-11:

12-19:

20+:

1.00 – 3.60

1.41 – 4.25

1.00 – 2.30

1.60 – 5.30

Limit of detection (LOD, see Data Analysis section) for Survey year 13-14 is 0.1. < LOD means less than the limit of detection, which may vary for some chemicals by year and by individual sample.

1 CDC. 2018. 2013-2014 NHANES 50th to 95th percentiles among children 12-19 years and adults 20+ years old from the Fourth National Report on Human Exposure to Environmental Chemicals, Updated Tables, March 2018. Accessed April 13, 2018 at (https://www.cdc.gov/exposurereport/pdf/FourthReport_UpdatedTables_Volume1_Mar2018.pdf).

‡ See Calculation of PFOS and PFOA as the Sum of Isomers for additional information in March 2018 Updated Tables.




Laboratory and Contact

Analyte

* CLIA Cert.

Matrix

Volume

NHANES 1

(µg/L)

2013 - 2014

Children and Adults

NCEH/Division of Laboratory Sciences*

Contact: Dr. Antonia Calafat

Per- and Poly-fluoroalkyl Substances (PFAS) (continued)

Yes

Serum

1 ml (for all PFAS);

1 ml reserve (for future PFAS analyses)

Age Group (years):

50th to 95th %

perfluorohexane sulfonic acid (PFHxS)

3-5:

6-11:

12-19:

20+:

0.740 – 1.62

0.850 – 4.14

1.10 – 6.30

1.40 – 5.50

perfluorooctane sulfonamide (PFOSA)

3-5:

6-11:

12-19:

20+:

< LOD – 0.110

< LOD - < LOD

n/a ‡

n/a ‡

2-(N-methyl-perfluorooctane sulfonamido) acetic acid (Me-PFOSAA)

3-5:

6-11:

12-19:

20+:

0.110 – 1.02

0.110 – 0.940

0.100 – 0.600

< LOD – 0.600

2-(N-ethyl-perfluorooctane sulfonamido) acetic acid (Et-PFOSAA)

3-5:

6-11:

12-19:

20+:

< LOD - < LOD

< LOD - < LOD

n/a ‡

n/a ‡

perfluorobutane sulfonic acid (PFBS)

3-5:

6-11:

12-19:

20+:

< LOD - < LOD

< LOD – 0.130

< LOD - < LOD

< LOD - < LOD

perfluoroheptanoic acid (PFHpA)

3-5:

6-11:

12-19:

20+:

< LOD – 0.310

< LOD – 0.170

< LOD – 0.200

< LOD – 0.100

Limit of detection (LOD, see Data Analysis section) for Survey year 13-14 is 0.1. < LOD means less than the limit of detection, which may vary for some chemicals by year and by individual sample. ‡ Not measured after Survey Years 2011-2012.

1 CDC. 2018. 2013-2014 NHANES 50th to 95th percentiles among children 12-19 years and adults 20+ years old from the Fourth National Report on Human Exposure to Environmental Chemicals, Updated Tables, March 2018. Accessed April 13, 2018 at (https://www.cdc.gov/exposurereport/pdf/FourthReport_UpdatedTables_Volume1_Mar2018.pdf).

Laboratory and Contact

Analyte

* CLIA Cert.

Matrix

Volume

NHANES 1

(µg/L)

2013 - 2014

Children and Adults

NCEH/Division of Laboratory Sciences*

Contact: Dr. Antonia Calafat

Per- and Poly-fluoroalkyl Substances (PFAS) (continued)

Yes

Serum

1 ml (for all PFAS);

1 ml reserve (for future PFAS analyses)

Age Group (years):

50th to 95th %

perfluorononanoic acid (PFNA)

3-5:

6-11:

12-19:

20+:

0.620 – 3.49

0.750 – 3.19

0.500 – 2.00

0.700 – 2.00

perfluorodecanoic acid (PFDA)

3-5:

6-11:

12-19:

20+:

0.100 – 0.370

< LOD – 0.350

0.100 – 0.400

0.193 – 0.800

perfluoroundecanoic acid (PFUnDA)

3-5:

6-11:

12-19:

20+:

< LOD – 0.370

< LOD – 0.250

< LOD – 0.200

< LOD – 0.500

perfluorododecanoic acid (PFDoA)

3-5:

6-11:

12-19:

20+:

< LOD - < LOD

< LOD - < LOD

< LOD – 0.200

< LOD – 0.200

Laboratory and Contact

Proposed Biospecimen Bank for Future Analytes

* CLIA Cert.

Matrix

Volume

NHANES TBD

(µg/L)

20xx – 20xx

Children and Adults

NCEH/Division of Laboratory Sciences*

Contact: Dr. Antonia Calafat

Per- and Poly-fluoroalkyl Substances (PFAS)

Yes

Spot Urine (morning void)

1 ml (for PFAS);

15 ml for creatinine/or specific gravity)

Age Group:

50th to 95th %

To be determined (TBD) when analytical methods are developed

(Including but not limited to the following 18 analytes: PFOA

[n-PFOA;, Sb-PFOA], PFOA [n-PFOS, Sm-PFOS], PFHxS, PFBS, PFHpA, PFNA, PFDA, PFUnDA, PFPrS, PFHpS, PFBA, PFPeA, PFHxA, HFPO-DA (GenX), DONA, 9Cl-PF3ONS)

3-5:

6-11:

12-19:

20+:

TBD

TBD

TBD

TBD

Creatinine (for urinary creatinine correction; may be contracted)

TBD

Limit of detection (LOD, see Data Analysis section) for Survey year 13-14 is 0.1. < LOD means less than the limit of detection, which may vary for some chemicals by year and by individual sample. ‡ Not measured after Survey Years 2011-2012.

1 CDC. 2018. 2013-2014 NHANES 50th to 95th percentiles among children 12-19 years and adults 20+ years old from the Fourth National Report on Human Exposure to Environmental Chemicals, Updated Tables, March 2018. Accessed April 13, 2018 at (https://www.cdc.gov/exposurereport/pdf/FourthReport_UpdatedTables_Volume1_Mar2018.pdf).

Laboratory and Contact

Analyte

* CLIA Cert.

Matrix

Volume

Reportable Range, Guidelines,

Critical Values

Reference ranges will be updated when commercial lab is selected.

Children and Adults

Commercial Laboratory (to be determined)*

Contact:

Lipids

Yes

Serum

0.5 ml

(for all)


Total cholesterol, fasting

Coronary Heart Disease Risk (CHD)1

Adult, 18+ years:

Desirable: <200 mg/dL

Borderline High: 200-239 mg/dL

High: ≥240 mg/dL


Child, 2-17 years:

Acceptable: <170 mg/dL

Borderline high: 170-199 mg/dL

High: ≥200 mg/dL

Triglycerides, fasting

CHD Risk1

Adult, 18+ years:

Normal: <150 mg/dL

Borderline High: 150-199 mg/dL

High: 200-499 mg/dL

Very High: ≥500 mg/dL


Critical Value: >1,000 mg/dL


Child, 2-9 years:

Acceptable: <75 mg/dL

Borderline high: 75-99 mg/dL

High: ≥100 mg/dL


Child, 10-17 years:

Acceptable: <90 mg/dL

Borderline high: 90-129 mg/dL

High: > or =130 mg/dL

Low Density Lipoprotein (LDL), fasting

CHD Risk1

Adult, 18+ years:

Desirable: <100 mg/dL

Above Desirable: 100-129 mg/dL

Borderline high: 130-159 mg/dL

High: 160-189 mg/dL

Very high: ≥190 mg/dL


Child, 2-17 years:

Acceptable: <110 mg/dL

Borderline high: 110-129 mg/dL

High: ≥130 mg/dL

High Density Lipoprotein (HDL), fasting

CHD Risk1

Adult, 18+ years:

Males: ≥40 mg/dL

Females: ≥50 mg/dL


Child, 2-17 years:

Low: <40 mg/dL

Borderline low: 40-45 mg/dL

Acceptable: > 45 mg/dL



Laboratory and Contact

Analyte

* CLIA Cert.

Matrix

Volume

Reportable Range, Guidelines,

Critical Values

Reference ranges will be updated when commercial lab is selected.

Children and Adults

Commercial Laboratory (to be determined)*

Contact:

Uric Acid

Yes

Serum

1 ml

Males2

≤ 8.0 mg/dL

Females

≤ 6.1 mg/dL

Creatinine (to estimate glomerular filtration rate [eGFR])

Males3

1-2 years: 0.1-0.4 mg/dL

3-4 years: 0.1-0.5 mg/dL

5-9 years: 0.2-0.6 mg/dL

10-11 years: 0.3-0.7 mg/dL

12-13 years: 0.4-0.8 mg/dL

14-15 years: 0.5-0.9 mg/dL

> or =16 years: 0.8-1.3 mg/dL

Reference values have not been established for patients that are <12 months of age.

 

Females

1-3 years: 0.1-0.4 mg/dL

4-5 years: 0.2-0.5 mg/dL

6-8 years: 0.3-0.6 mg/dL

9-15 years: 0.4-0.7 mg/dL

> or =16 years: 0.6-1.1 mg/dL

Reference values have not been established for patients that are <12 months of age.

 

ESTIMATED GFR

>60 mL/min/BSA

Note: eGFR results will not be calculated for patients <18 or >70 years old.

Laboratory and Contact

Analyte

* CLIA Cert.

Matrix

Volume

Reportable Range, Guidelines,

Critical Values

Reference ranges will be updated when commercial lab is selected.

Children and Adults

Commercial Laboratory (to be determined)*

Contact:

Thyroid Hormones

Yes

Serum

0.5 ml


Thyroid Stimulating Hormone (TSH)

0.30-3.0 mIU/L 4

Free Total Thyroxine (Free T4)

0.8-2.0 ng/dL

Total Thyroxine (TT4)

4.5-12.5 µg/dL

Total Triiodothyronine (TT3)

80-180 ng/dL

Commercial Laboratory (to be determined)*

Contact:

Liver Tests

Yes

Serum

0.5 ml standard tests;

1 ml CK18



Alanine transaminase (ALT)

15-65 U/L 5

Aspartate transaminase (AST)

5-40 U/L

Alkaline phosphatase (ALP)

Female: 50-136 U/L;

Male: 40-136 U/L

Gamma-glutamyltransferase (GGT)

Female 5-55 U/L;

Male 5-85 U/L



Albumin (Alb)

3.4-5.0 g/dL


Critical Value: <1.5 g/dL

Critical Value: >7.9 g/dL

Total bilirubin (TBIL)

0.0 – 1.0 mg/dL


Critical Value: >12.9 mg/dL

Direct bilirubin (Conjugated Bilirubin)

0.0-0.3 mg/dL



Non-alcoholic fatty liver disease (NAFLD)/steatohepatitis


Cytokeratin 18 M30 (CK-18 M30)

Cytokeratin 18 M65 (CK-18 M65)

No evident liver disease: M30 <200 U/L and M65 <300 U/L

TASH: M30<200 U/L and M65 >300 U/L

Other liver disease: M30: >200 U/L

Laboratory and Contact

Analyte

* CLIA Cert.

Matrix

Volume

Reportable Range, Guidelines,

Critical Values

Reference ranges will be updated when commercial lab is selected.

Children and Adults

Commercial Laboratory (to be determined)*

Contact:

Sex Hormones

Yes

Serum

0.5 ml


Testosterone

Males6        

4-9 years: <7-20 ng/dL

10-11 years: <7-130 ng/dL

12-13 years: <7-800 ng/dL

14 years: <7-1,200 ng/dL

15-16 years: 100-1,200 ng/dL

17-18 years: 300-1,200 ng/dL

≥19 years: 240-950 ng/dL      


Females           

4-9 years: <7-20 ng/dL

10-11 years: <7-44 ng/dL

12-16 years: <7-75 ng/dL

17-18 years: 20-75 ng/dL

≥19 years: 8-60 ng/dL

Estradiol

CHILDREN7

Males

Tanner Stages

Reference Range

Stage I (>14 days and prepubertal)

<LOD-13 pg/mL

Stage II

<LOD-16 pg/mL

Stage III

<LOD-26 pg/mL

Stage IV

<LOD-38 pg/mL

Stage V

10-40 pg/mL



Females

Tanner Stages

Mean Age

Reference Range

Stage I (>14 days and prepubertal)

7.1 years

Undetectable-20 pg/mL

Stage II

10.5 years

Undetectable-24 pg/mL

Stage III

11.6 years

Undetectable-60 pg/mL

Stage IV

12.3 years

15-85 pg/mL

Stage V

14.5 years

15-350 pg/mL**


ADULTS

Males: 10-40 pg/mL

Females

Premenopausal: 15-350 pg/mL**

Postmenopausal: <10 pg/mL

**E2 levels vary widely through the menstrual cycle.

Sex hormone-binding globulin (SHBG)

CHILDREN8

Males

Tanner Stages

Reference Range

Stage I

31-167 nmol/L

Stage II

49-179 nmol/L

Stage III

5.8-182 nmol/L

Stage IV

14-98 nmol/L

Stage V

10-57 nmol/L


Females

Tanner Stages

Reference Range

Stage I

43-197 nmol/L

Stage II

7.7-119 nmol/L

Stage III

31-191 nmol/L

Stage IV

31-166 nmol/L

Stage V

18-144 nmol/L


ADULTS          

Males: 10-57 nmol/L

Females (non-pregnant): 18-144 nmol/L

Follicle stimulating hormone (FSH)

Males9

4-6 years: < or =6.7 IU/L

7-8 years: < or =4.1 IU/L

9-10 years: < or =4.5 IU/L

11 years: 0.4-8.9 IU/L

12 years: 0.5-10.5 IU/L

13 years: 0.7-10.8 IU/L

14 years: 0.5-10.5 IU/L

15 years: 0.4-18.5 IU/L

16 years: < or =9.7 IU/L

17 years: 2.2-12.3 IU/L

≥18 years: 1.0-18.0 IU/L

Females

15 days-6 years: < or =3.3 IU/L

7-8 years: < or =11.1 IU/L

9-10 years: 0.4-6.9 IU/L

11 years: 0.4-9.0 IU/L

12 years: 1.0-17.2 IU/L

13 years: 1.8-9.9 IU/L

14-16 years: 0.9-12.4 IU/L

17 years: 1.2-9.6 IU/L

≥18 years:

Premenopausal

Follicular: 3.9-8.8 IU/L

Midcycle: 4.5-22.5 IU/L

Luteal: 1.8-5.1 IU/L

Postmenopausal: 16.7-113.6 IU/L

Insulin-like growth factor (IGF-1)




Laboratory and Contact

Analyte

* CLIA Cert.

Matrix

Volume

Reportable Range, Guidelines,

Critical Values

Reference ranges will be updated when commercial lab is selected.

Children and Adults

Commercial Laboratory (to be determined)*

Contact:

Immune Function

Yes

Serum

1 ml


Ig A, Ig G, Ig M, Ig E


Commercial Laboratory (to be determined)*

Contact:

Glycemic Parameters

Yes




Glycosylated hemoglobin (HbA1c)

Whole Blood EDTA

1 ml;

plus 1 ml reserve

Diabetes Risk10

Normal: <5.7%

Increased Risk Diabetes: 5.7-6.4%

Diabetes: ≥6.5% (confirmation required)

Glucose, fasting, 8-hour

Serum

0.5 ml Glucose/

Insulin;

1 ml antibodies


Insulin

<17 µU/ml 8

Glutamate Decarboxylase -65 (Anti-GAD 65)

Negative Antibody: DK≤33 8

Positive Antibody: DK>33

Thyrosine Phosphatase-like Protein Autoantibodies (Anti-IA2)

Negative Antibody: DK<5 8

Positive Antibody: DK≥5

Children Only

Commercial Laboratory (to be determined)*

Contact:

Antibodies to measles, mumps, rubella, tetanus, and diphtheria

Yes

Serum

1 ml


Child Total

Serum - 9ml Whole Blood – 2 ml Urine – 16 ml

Red Top 2 x10 ml EDTA Lavender Top 3 ml



Adults Only

Commercial Laboratory (to be determined)*

Contact:

Autoimmune Parameters

Yes

Serum

2 ml (for all)


Rheumatoid Factor (RF)

< 15 IU/mL11

Antinuclear Antibody (ANA) screen

< or =1.0 U (negative)12

1.1-2.9 U (weakly positive)

3.0-5.9 U (positive)

> or =6.0 U (strongly positive)

Antinuclear Antibody (ANA) titer


Adult Total

Serum – 11 ml Whole Blood – 2 ml Urine – 16 ml

Red Top 3 x 10 ml EDTA Lavender Top 3 ml



4 University of Southern California Clinical Laboratories Endocrine Services.

5 University of Louisville Department of Medicine, Gastroenterology (updated 14 October 2015).

10 American Diabetes Association. Standards of Medical Care in Diabetes - 2011. Diabetes Care. January 2011;34(Supplement 1):S11-S61 (subject to periodic update).


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