6.

Procedure of the test

1. Remove the test device from the foil pouch, place it on a flat, dry surface.
2. Using a micropipette, add 10 ul of plasma or serum specimen into the sample
well (s).
3. Add 4 drops of assay diluent into sample well (s).
4. As the test begins to work, you will see purple color move across the result
window in the center of the test device.
5. Interpret test results in 5-30 minutes.
7. Interpretation of the test

A color band will appear in the left section of the result window to show that
the test is working properly. This band is control line (C).
Color band will appear in the right section of the result window. This band is
the test line.
a. Negative result: The presence of only one band within the result
window.
b. Positive result: The presence of two color bands (T band & C band)
within the result window, no matter which band appears first.
c. Invalid result: If the purple color band is not visible within the result
window after performing the test, the result is considered invalid. Some
causes of invalid results are: not following the directions correctly or
the test may have deteriorated beyond the expiration date. It is
recommended that the specimen be re-tested using a new test kit.

8. Limitations of the test

A negative result does not preclude the possibility of infections with HCV.
Other clinically available tests are required if questionable results are
obtained. As with all diagnostic tests, a definitive clinical diagnosis should not
be based on the results of a single test, but should only be made by the
physician after all clinical and laboratory finding have been evaluated.

9. Performance Characteristics
1. Sensitivity and Specificity
The SD BIOLINE HCV have tested with positive and negative clinical
samples tested by confirmatory assay using RT-PCR.
Reference
Positive
Negative
Total Results
Sensitivity
Specificity

RT-PCR

2. Precision

SD BIOLINE HCV
Total
Positive
Negative
Results
157
0
157
6
1024
1030
163
1024
1187
157/157 x 100 = 100%
1024/1030 x 100 = 99.4%

Within run precision was determined by using 10 replicates of four

different specimens containing different concentrations of antibody.
The negative and positive values were correctly identified 100% of the
time.
Between run precision was determined by using the four different
specimens containing different concentrations of antibody in 3
different replicates with 3 different lots of test devices. Again negative
and positive results were observed 100% of time.