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Quick Details

  • Type: Pathological Analysis Equipments, hepatitis b test
  • Brand Name: HIGHTOP
  • Place of Origin: Shandong, China (Mainland)
  • Model Number: H126-43W-LL01
  • Specimen: Serum/Plasma/Whole Blood
  • Reaction time: 15-20minutes
  • Format: Strip,card,combo
  • Expiration date: 24 months
  • Tademark: Our trademrk or OEM client's
  • Certificate: CE ,ISO13485,CFDA ,Free sales certificate
  • Packing: (strip100, card30,combo20)Pcs/Box
  • Scope: Hospital,lab,clinic,university
  • Storage temperature: 4-30 degree celsius

Packaging & Delivery

Packaging Details (strip100, card30,combo20)Pcs/Box
Delivery Time 3-7 working days after received advance payment.
 Product Description

 

Item Name : medical diagnostic test kits,rapid test kit,hepatitis b test kit

 

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.    

 

 

positive coincidence rate

negative coincidence rate

HBeAg

98.71%

100%

HBeAb

99.35%

99.86%

HBcAb

99.83%

99.50%

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

Store at room temperature 4-30 °C, avoid hot and sunshine, dry place, not frozen, valid for 24 months. This kit can be short-term room temperature transport, in summer and winter should take certain protective measures to avoid heat or freezing and thawing.

 

Packaging & Shipping

 

 

 

 

 

Our Services

 

1. Provide OEM service. We could do your own brnad packing according to your requiremnet.

2. Original manufacturer, competitive price.

3. Smooth delivery at Qingdao Port, by Sea, by Air, by Express.

4. Positive attitude to every customer, we would like to discuss more details by email, by phone or on line.

5. Free samples could be sent for your evaluation.

 

Sample Service Provide free samples for clients to test the quality (no more than 5pcs are for free).

OEM Service 

We are original manufacturer,OEM your own brand, and do the packing according to your requirement.

(The quantity is no less than 30,000pcs for each test kit)  

Company Information

We are manufactory of IVD rapid test kits .

products category:
Cardiac Markers Test,HBV Test,HCV Test,Fertility Test, Prepotency Test,

Sexually Transmitted Diseases Test,Tumor Markers Test,Drugs of Abuse Tests,
We have 3 factories in Shandong province.China
Most of our products passed ISO9001,ISO13485,cFDA,Free Sale Certificates and CE mark.
OEM Service is available ! Welcome contact me to talk about above items !
 


 

Attend Exhibition:

Our faces always appear In German ,Chicago ,Russia ,Dubai ,Sao Paulo, Mumbai,Shenzhen,

We are looking forword to seeing you !

 

 

Detail informations about this item ,welcome talk to us ! Glad to service you .

Laura Lee

Qingdao Hightop Biotech Co.,Ltd

E-Mail:    laura (at) hightopqd.com 

Skype:    lghbearing

Tel:         0086-0532-58710707

Mobile:   0086-15954805398 (whatapp and wechat are available)
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