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membrane. All three lines in result window are not visible before applying any
samples. The Control Line is used for procedural control. Control line should
always appear if the test procedure is performed properly and the test reagents of
control line are working. A purple G and M lines will be visible in the result
window if there are enough IgG and/or IgM antibodies to Hepatitis A virus in the
sample. If IgG and/or IgM antibodies to Hepatitis A virus are not present in the
sample, there is no color appearance in G and/or M.
1. SD BIOLINE HAV IgG/IgM kit contains following items to perform the assay.
Test devices individually foil pouched with a desiccant
Assay diluent (5ml/vial)
5 capillary pipette
Instruction for use
2. Active ingredients of main components
1 test device included ; Gold Conjugates (as main component) : Mouse
monoclonal anti-Hepatitis A Virus-gold colloid (10.2), Test line G (as
main component) : Mouse monoclonal anti-human IgG (40.8), Test line
M (as main component) : Mouse monoclonal anti-human IgM (40.8),
Control line (as main component) : Goat anti-mouse IgG) (81.6)
Assay buffer include ; 100 mM Phosphate buffer, Tween 20 (0.1%),
Sodium azide (0.01%)
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Warnings
For in vitro diagnostic use only. DO NOT RE-USE test device.
Do not eat or smoke while handling specimens.
Wear protective gloves while handling specimens. Wash hands thoroughly afterwards.
Avoid splashing or aerosol formation.
Clean up spills thoroughly using an appropriate disinfectant.
Decontaminate and dispose of all specimens, reaction kits and potentially
contaminated materials, as if they were infectious waste, in a biohazard container.
7. Do not use the test kit if the pouch is damaged or the seal is broken.
8. The instruction must be followed exactly to get accurate results.
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Performance Characteristics
The performance of the SD BIOLINE HAV IgG/IgM Rapid test was evaluated with
commercial HAV IgM Rapid test. We used 125 samples for positive and 150 samples for negative. We found the relative sensitivity is 97.6% (122/125), the relative
specificity is 98.0% (147/150). The results are summarized in the following tables.
SD BIOLINE HAV
IgG/IgM Rapid
Positive
Specimens
Confirmed
by ELISA Negative
Specimens
Sensitivity
Specificity
Total
Positive
Negative
Positive
Negative
122
104
21
125
147
131
19
150
97.6 % (122/125)
98.0 % (147/150)
83.2 % (104/125)
87.3 % (131/150)