goals for serum thyroglobulin assays. Clin Chem
1996;42:164-73. 16) Spencer CA. Recoveries
cannot be used to authenticate thyroglobulin
(Tg) measurements when sera contain Tg
autoantibodies. Clin Chem 1996;42:661-3.
17) National Committee for Clinical Laboratory
Standards. Procedures for the collection of
diagnostic blood specimens by venipuncture;
approved standard. 4th ed. NCCLS Document
H3-A4, Wayne, PA: NCCLS, 1998. 18) Centers
for Disease Control. Update: Universal
precautions for prevention of transmission of
human immunodeficiency virus, hepatitis B virus
and other bloodborne pathogens in healthcare
settings. MMWR, 1988;37:377–82, 387–8.
19) Clinical and Laboratory Standards Institute
(formerly NCCLS). Protection of Laboratory
Workers From Occupationally Acquired
Infections; Approved Guideline - Third Edition.
Wayne, PA: Clinical and Laboratory Standards
Institute; 2005. NCCLS Document M29-A3.
20) Federal Occupational Safety and Health
Administration, Bloodborne Pathogens
Standard, 29 CFR 1910.1030.
Technical Assistance
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Tables and Graphs
Precision (ng/mL)
Within-Run
3
4
Mean
SD
1
10
0.48
2
59
3.5
3
13
0.82
4
20
1.0
5
279
19
IMMULITE 2000 Thyroglobulin (PIL2KTY-22, 2015-04-22)
1
2
Total
5
CV
SD
CV
4.8%
0.56 5.6%
5.9%
3.6
6.1%
6.3%
0.85 6.5%
5.0%
2.0
10%
6.8%
20
7.2%
Linearity (ng/mL)
1
2
Dilution
Observed
1
16 in 16
63
8 in 16
31
4 in 16
15
2 in 16
7.3
1 in 16
3.7
2
16 in 16
82
8 in 16
37
4 in 16
19
2 in 16
10
1 in 16
4.7
3
16 in 16
96
8 in 16
44
4 in 16
21
2 in 16
10
1 in 16
5.1
4
16 in 16
140
8 in 16
70
4 in 16
34
2 in 16
17
1 in 16
8.3
Specificity
2
Added
1
Compound
ng/mL
AFP
19,000
FSH
200
TSH
560
T2
48,000
T3
10,000
T4
10,000
5
ND: not detectable
3
4
Expected
%O/E
—
—
32
97%
16
94%
7.9
92%
3.9
95%
—
—
41
90%
21
91%
10
100%
5.1
92%
—
—
48
92%
24
88%
12
83%
6.0
85%
—
—
70
100%
35
97%
18
94%
8.8
94%
Apparent
% Cross-
3
4
ng/mL
reactivity
ND
ND
0.11
ND
0.09
ND
ND
ND
ND
ND
ND
ND
7