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Performance Characteristics of the Avecon Diagnostics,
Inc.
Tetanus Antibody Test Kit
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Target Concentration
(IU/mL)
|
Result
(IU/mL)
|
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0
|
0
|
| |
0
|
1
|
| |
0
|
1
|
| |
0
|
0
|
| |
0
|
0
|
| |
0
|
0
|
| |
0
|
0
|
| |
0
|
0
|
| |
0
|
0
|
| |
0
|
1
|
| |
0
|
0
|
| |
0
|
0
|
| |
0
|
0
|
| |
0
|
1
|
| |
0
|
1
|
| |
0
|
0
|
| |
0
|
0
|
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0
|
1
|
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0
|
0
|
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0
|
1
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Average
|
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0.35
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Standard Deviation
|
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0.48
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3 S.D.
|
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1.4
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Based on these results, it was determined that the sensitivity
of the Tetanus Antibody Test is 1.8 IU/mL tetanus antibody
(0.35 + 1.4).
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Linearity -
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|
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- The linearity of the Avecon Tetanus Antibody Test was
determined by running successively higher concentrations
of tetanus antibody added to negative serum, and determining
the concentration at which the curve ceased to form a
straight line. Tetanus antibody concentrations were quantitated
using the standard curve provided with the kit.
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Target Concentration
(IU/mL)
|
Result
(IU/mL)
|
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10
|
10
|
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15
|
15
|
|
25
|
25
|
|
50
|
56
|
|
75
|
90
|
|
100
|
111
|
|
125
|
111
|
|
150
|
107
|
|
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Based on these results, it was determined that
the Avecon Tetanus Antibody Test is linear up to 100 IU/mL
tetanus antibody. |
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Precision - |
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|
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The precision of the Tetanus Antibody Test was
determined by: |
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|
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- Assaying the quantity of tetanus antibody in the tetanus
antibody reference material provided by the National Institute
of Biological Standards and Controls (NIBSC, United Kingdom),
Lot # 76/589. Tetanus antibody concentrations were
quantitated using the standard curve provided with the
kit.
- Determination of inter- and intra- assay precision of
the test using negative serum to which was added tetanus
antibody at concentrations of 10, 15 and 25 IU/mL. Tetanus
antibody concentrations were quantitated using the standard
curve provided with the kit.
|
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A. NIBSC Tetanus Antibody Standard
Reference Material, Lot # 76/589 (n = 6) - |
| |
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Target Concentration
(IU/mL)
|
Result
(IU/mL)
|
| |
9.2
|
10
|
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9.2
|
10
|
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9.2
|
9
|
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9.2
|
9
|
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9.2
|
9
|
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9.2
|
8
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Mean
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9.2
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Standard Deviation
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0.69
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C.V. (%)
|
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7.5
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B. Inter-Assay Precision - Tetanus
antibody was added to negative serum at three (3) different
concentrations (10, 15 and 25 IU/mL) and each were run on
the same day (n = 20). Tetanus antibody concentrations were
quantitated using the standard curve provided with the kit.
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10 IU/mL
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15 IU/mL
|
25 IU/mL
|
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10
|
14
|
25
|
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10
|
14
|
25
|
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11
|
14
|
23
|
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10
|
15
|
25
|
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11
|
16
|
24
|
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10
|
14
|
23
|
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9
|
14
|
25
|
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11
|
15
|
24
|
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11
|
15
|
24
|
| |
10
|
14
|
25
|
| |
11
|
15
|
25
|
| |
10
|
15
|
26
|
| |
11
|
14
|
26
|
| |
10
|
15
|
24
|
| |
11
|
15
|
25
|
| |
11
|
15
|
25
|
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10
|
15
|
24
|
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11
|
14
|
24
|
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11
|
15
|
25
|
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Mean
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10.5
|
14.6
|
24.5
|
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Standard Deviation
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0.59
|
0.58
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0.8
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C.V. (%)
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5.6
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4
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3.3
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C. Intra-Assay Precision - Tetanus
antibody was added to negative serum at three (3) different
concentrations (10, 15 and 25 IU/mL) and each were assayed
once per day for 15 days (n = 15). Tetanus antibody concentrations
were quantitated using the standard curve provided with the
kit. The same Tetanus Antibody Test kit was used for
all analyses. |
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10 IU/mL
|
15 IU/mL
|
25 IU/mL
|
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11
|
15
|
23
|
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11
|
15
|
25
|
| |
10
|
15
|
24
|
| |
10
|
15
|
24
|
| |
10
|
15
|
24
|
| |
10
|
14
|
25
|
| |
11
|
15
|
24
|
| |
11
|
15
|
24
|
| |
11
|
15
|
24
|
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11
|
16
|
24
|
| |
10
|
15
|
25
|
| |
10
|
15
|
25
|
| |
11
|
15
|
25
|
| |
11
|
15
|
24
|
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11
|
14
|
23
|
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Mean
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10.6
|
14.9
|
24.2
|
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Standard Deviation
|
0.5
|
0.44
|
0.65
|
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C.V. (%)
|
4.7
|
3
|
2.7
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The effects of interfering substances on the
ability of the Tetanus Antibody Test to accurately determine
the quantity of tetanus antibody in biological specimens was
determined by the addition of triglycerides (750 mg/dL), hemoglobin
(1000 mg/dL) and bilirubin (25 mg/dL) to a serum specimen
containing 25 IU/mL tetanus antibody, and assaying the amount
of tetanus antibody in the adulterated specimens using the
standard curve provided with the kit. The results are
as follows: |
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A. Triglycerides, 750 mg/dL (n
= 7) - |
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|
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Target Concentration
(IU/mL)
|
Result
(IU/mL)
|
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25
|
22
|
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25
|
25
|
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25
|
28
|
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25
|
24
|
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25
|
27
|
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25
|
24
|
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25
|
26
|
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Mean
|
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25.1
|
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Standard Deviation
|
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1.9
|
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C.V. (%)
|
|
7.6
|
|
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B. Hemoglobin, 1000 mg/dL (n =
7) - |
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Target Concentration
(IU/mL)
|
Result
(IU/mL)
|
| |
25
|
27
|
| |
25
|
28
|
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25
|
27
|
| |
25
|
28
|
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25
|
27
|
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25
|
27
|
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25
|
26
|
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Mean
|
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27.1
|
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Standard Deviation
|
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0.64
|
|
C.V. (%)
|
|
2.4
|
|
| |
C.
Bilirubin, 25 mg/dL (n = 7) - |
| |
| |
Target Concentration
(IU/mL)
|
Result
(IU/mL)
|
| |
25
|
24
|
| |
25
|
23
|
| |
25
|
24
|
| |
25
|
25
|
| |
25
|
24
|
| |
25
|
25
|
| |
25
|
25
|
|
Mean
|
|
24.3
|
|
Standard Deviation
|
|
0.7
|
|
C.V. (%)
|
|
2.9
|
|
|
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|
   
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page last revised on
September 19, 2002
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