IVD Infections disease diagnostic Hepatitis B Virus combo test kit HBsAg ,HBsAb,HBeAg ,HBeAb, HBcAb 5 in 1 test panel HB

IVD Infections disease diagnostic Hepatitis B Virus combo test kit HBsAg ,HBsAb,HBeAg ,HBeAb, HBcAb 5 in 1 test panel HBV combo test card
 

 
Introduction
 

 
 
Compositions
HBsAg test strip: anti-HBsAg monoclonal antibody A (solid gold standard material), anti HBsAg monoclonal antibody B (test line), goat anti-mouse IgG (control line).
HBsAb test strip: Purified HBsAg (solid gold standard material), purified HBsAg (test line), HBsAg monoclonal antibody (control line).
HBeAg test strip: anti-HBeAg monoclonal antibody A (solid gold standard material), anti-HBeAg monoclonal antibody B (test line), goat anti-mouse IgG (control line).
HBeAb test strip: anti-HBeAg monoclonal antibody A (solid gold standard material), anti-HBeAg monoclonal antibody B (test line), goat anti-mouse IgG (control line).
HBcAb test strips: Recombinant HBcAg (solid gold standard material), anti-HBcAg monoclonal antibody A (test line), recombinant HBcAg monoclonal antibody (control line).
 
Requirements on Specimen
1. Serum, plasma, whole blood samples collected by venous conventional methods, test samples must be collected with a clean container, can be used anticoagulant heparin, EDTA, sodium citrate,Sodium oxalate
2. After collection separate the serum and plasma as soon as possible, in order to avoid hemolysis. Use fresh specimens.
3. Serum, plasma, whole blood samples stored at 2-8 °C in refrigerator preferably not
more than 3 days, if not tested immediately should be stored at -20 °C.
 
Test Procedure
1. Remove the bag from the original packaging (Note: Open the bags should be preceded by the reagents and samples to room temperature. use it in 1 hour (20% -90% humidity, temperature:10 °C -50 °C)
2. Open the sealed foil pouch; remove the test panels, flat on the horizontal table number (corresponding with the specimen)
3. Drop (about 50ul) sample in the detection of sample holes on the card, and then drop two drops specimen buffer to each well.
4. 15-20 minutes of observation, the results no clinical significance after 20 minutes.
 
Result Judgment
HBsAg HBsAb HBeAg:
Positive: Two red band appears in the test area (T), another in the control area(C). The positive results show that: samples containing analysts.
Negative: Only control line (C) a red band appears in the detection zone (T) without the red band appears. The negative results show that: samples don’t containing analysts.
Invalid: Quality control area (C) does not appear red band, indicating that the operator error or reagent failure.
HBeAb HBcAb:
Positive: Only control line (C) a red band appears in the detection zone (T) without the red band appears. The positive results show that: samples containing analysts. If the quality control area C has a red band, the test area T has a very weak red band, which is called weakly positive, indicating that the samples contain a small amount of antibodies.
Negative: Two red band appears in the test area (T), another in the control area(C). The negative results show that: samples don’t containing analysts.
Invalid: Quality control area (C) does not appear red band, indicating that the operator error or reagent failure.
Performance indicators
The detection limit of three subtypes of HBsAg (ADR, ADW, AY) is not more than 2.5NG/ML The detection limit of HBsAg not higher than 30.0mlu/ml.

 
Attentions
1. Do not uses test kit beyond expiry date. Please check the package and the contents are complete before use, if damaged, cannot be used.
2. Serum, plasma, whole blood specimens were stored with the refrigerator 2-8 °C best not more than 3 days, if not timely detection then -20 °C frozen and the specimen is mixed melting and to avoid repeated freezing and thawing.
3. Test line color intensity level of the sample are not necessarily linked in the antibody titer, Positive results cannot be confirmed as a basis before further confirmatory testing done.
4. The strength of control line does not represent the quality of reagents, the reagent effective as long as its color clearly visible.
5. If the filtration speed is very slow or evens no filtration, please retreat the specimen and test again.
Storage and Expiry
Room temperature4-30 °C, avoid hot and sunshine, dry place, not frozen, valid for 24 months.