Performance Characteristics of the Avecon Diagnostics, Inc.
Tetanus Antibody Test Kit
 

Sensitivity -
   
 

The sensitivity of the Avecon Tetanus Antibody Test was defined as the average plus three (3) standard deviations of a series of negative serum specimens (n = 20) run with the test kit. Tetanus antibody concentrations were quantitated using the standard curve provided with the kit.

 
 
 

Target Concentration
(IU/mL)

Result
(IU/mL)
 
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
 
0
1
 
0
0
 
0
1
Average
  
0.35
Standard Deviation
  
0.48
3 S.D.
  
1.4
 

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).

 

Linearity -

   
 
  1. 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.
 

Target Concentration
(IU/mL)

Result
(IU/mL)
10
10
15
15
25
25
50
56
75
90
100
111
125
111
150
107
  Based on these results, it was determined that the Avecon Tetanus Antibody Test is linear up to 100 IU/mL tetanus antibody.
  Precision -
   
  The precision of the Tetanus Antibody Test was determined by:
   
 
  1. 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.
  2. 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.
 
Results
  A.    NIBSC Tetanus Antibody Standard Reference Material, Lot # 76/589 (n = 6) -
 
 

Target Concentration
(IU/mL)

Result
(IU/mL)
 
9.2
10
 
9.2
10
 
9.2
9
 
9.2
9
 
9.2
9
 
9.2
8
Mean
  
9.2
Standard Deviation
  
0.69
C.V. (%)
  
7.5
  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.
 
 

10 IU/mL

15 IU/mL

25 IU/mL
 
10
14
25
 
10
14
25
 
11
14
23
 
10
15
25
 
11
16
24
 
10
14
23
 
9
14
25
 
11
15
24
 
11
15
24
 
10
14
25
 
11
15
25
 
10
15
26
 
11
14
26
 
10
15
24
 
11
15
25
 
11
15
25
 
10
15
24
 
11
14
24
 
11
15
25
Mean
10.5
14.6
24.5
Standard Deviation
0.59
0.58
0.8
C.V. (%)
5.6
4
3.3
  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.
 
 

10 IU/mL

15 IU/mL

25 IU/mL
 
11
15
23
 
11
15
25
 
10
15
24
 
10
15
24
 
10
15
24
 
10
14
25
 
11
15
24
 
11
15
24
 
11
15
24
 
11
16
24
 
10
15
25
 
10
15
25
 
11
15
25
 
11
15
24
 
11
14
23
Mean
10.6
14.9
24.2
Standard Deviation
0.5
0.44
0.65
C.V. (%)
4.7
3
2.7
  Interfering Substances -
  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:
  A.    Triglycerides, 750 mg/dL (n = 7) -
 

 

Target Concentration
(IU/mL)

Result
(IU/mL)
 
25
22
 
25
25
 
25
28
 
25
24
 
25
27
 
25
24
 
25
26
Mean
  
25.1
Standard Deviation
  
1.9
C.V. (%)
  
7.6
  B.    Hemoglobin, 1000 mg/dL (n = 7) -
 
 

Target Concentration
(IU/mL)

Result
(IU/mL)
 
25
27
 
25
28
 
25
27
 
25
28
 
25
27
 
25
27
 
25
26
Mean
  
27.1
Standard Deviation
  
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