China Export Advanced Quality Rapid HBsAg Test Strip

Overview
Product nameChina Export Advanced Quality Rapid HBsAg Test StripSpecimen Serum/Whole bloodAccuracyOver 99%Sensitivity4NCU/mlRead time3-5minStorageRoom Temperature 2--40Format / SizeStrip: 2.5mm 3.0mm 4.0mmPayment termL/C, T/T, Western Union and Paypal are all availableServiceOEM available
Intended use
Hepatitis B Surface Antigen Test is a lateral flow immunoassay for the simultaneous detection and differentiation of Hepatitis B Surface Antigen in human serum, plasma, or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HBV. Any reactive specimen with the Hepatitis B Surface Antigen Rapid Test must be confirmed with alternative testing method(s) such as ELISA or PCR.
Introduction
Hepatitis B Surface Antigen is the coat protein of Hepatitis B,it does not have infectivity. It is often associated with the presence of hepatitis b virus, so it is a sign of infected with hepatitis B virus.
In a typical Hepatitis B infection, HBsAg will be detected 2 to 4 weeks before the ALT level becomes abnormal and 3 to 5 weeks before symptoms or jaundice develop. HBsAg has four principal subtypes: adw, ayw, adr and ayr. Because of antigenic heterogeneity of the determinant, there are 10 major serotypes of Hepatitis B virus. The test utilizes a combination of monoclonal antibodies to selectively detect elevated levels of HBsAg in whole blood, serum or plasma.
1. Insert Each kit contains 1-50 test devices, each sealed in a foil pouch with two items inside:
a. 1 strip device.
b. 1 desiccant.
2. Sample diluent
3. One package insert (instruction for use).
Specimen collection
Consider any materials of human origin as infectious and handle them using standard biosafety procedures.
Plasma
1. Collect blood specimen into a lavender, blue or green top collection tube (containing EDTA,citrate or heparin, respectively in Vacutainer ) by veinpuncture.
2. Separate the plasma by centrifugation.
3. Carefully withdraw the plasma into new pre-labeled tube.
Serum
1. Collect blood specimen into a red top collection tube (containing no anticoagulants in Vacutainer ) by veinpuncture.
2. Allow the blood to clot.
3. Separate the serum by centrifugation.
4. Carefully withdraw the serum into a new pre-labeled tube.
Test specimens as soon as possible after collecting. Store specimens at 2 °C to 8°C if not tested immediately. The specimens could be stored at 2°C to 8°C up to 5 days. The specimens should be frozen at -20°C for longer storage. Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing.
Whole Blood
Drops of whole blood can be obtained in a clean container containing anti-coagulant (EDTA,citrate or heparin) by either fingertip puncture or veinpuncture. Do not use any hemolized blood for testing. Whole blood specimens should be stored in refrigeration (2℃ -8℃ ) if not tested immediately. The specimens must be tested within 24 hours of collection.
Test procedure
Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.
Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
Step 3: Be sure to label the device with specimen’s ID number.
Step 4:
For whole blood test
Lay the strip on a clean, dry, flat surface.Using the plastic dropper to draw a drop of sample into the bottom of the kit where the arrow indicated.
Then draw one drop of buffer provided into the same place.
For serum or plasma test
Immerse the strip into the sample with the arrow end pointing towards the sample. Do not immerse past the MAX (maximum) line. Take the strip out after 8-10 seconds and lay the strip flat on a clean, dry, flat surface.
Step 5: Set up timer.
Step 6: Results can be read in 15 minutes.
Don’t read result after 15 minutes. To avoid confusion, discard the test device after interpreting the result.
Interpretation of results
positive (+)
In addition to a pink colored control (C) band, a distinct pink colored band will also appear in the test (T) region.
Negative (-)
only one colored band appears on the control (C) region. No apparent band on the test (T) region.
Invalid
If a color band is not visible in the control region or a color band is only visible in the test region, the test is invalid. Another test should be run to re-evaluate the specimen. Please contact the distributor or the store, where you bought the product, with the lot number.
Note: There is no meaning attributed to line color intensity or width.
Company Information
Voyage Medical Co., Ltd is a professional company specialized in diagnostic rapid test devices and hospital beds. With our own factory, we provide worldwide customers the service of made-to-order manufacturing at competitive prices and good quality. Meet customer’s needs and achieve win-win situation has always been the goal of our efforts.
Our company has strong R & D team, rich experience and strong technical strength. The establishment of a joint laboratory with a number of colleges and universities outside the province, give full play to production, science research, combined the advantages of research focused on quick detection products.
Main Products
At present, voyage has infectious disease detection, tumor marker detection, drug abuse test, pregnancy and eugenics diagnosis and many other series of rapid qualitative diagnosis products, including AIDS, syphilis, hepatitis series test products, home hormone electronic probe, blood glucose test system, immune colloidal gold quantitative detection system, dry quantitative biochemical detection system.
Packaging & Shipping
To better ensure the safety of your goods, professional, environmentally friendly, convenient and efficient packaging services will be provided.
Our Services
Advantage:
1. Popular sell at home and abroad.
2. Nice assessment and feedback.
3. High return rate of single.
After-sales service
Rapid Test Service assurance
Service tenet: quick and decisive and thoughtful thorough and accurate;
Service objectives: service quality to win customer satisfaction;
Service efficiency: the period, we will have a dedicated staff to detect problems with the product for testing, and promptly get back to you;
Service principles: products in the course of product issues caused by improper operation, we will provide a solution.
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FAQ
1.Q:Are you a factory or trading company?
A:We are a trading company with our own factory.
2.Q:Where is your factory located? How can I visit there?
A:Our factory is located in Nantong City, Jiangsu Province, China, near to the Shanghai. You can fly to Shanghai airport directly.All our clients, from home or abroad, are warmly welcome to visit us!
3.Q:What is MOQ?
A: The MOQ depends on different products, generally speaking is 20.000pcs but we can do your requirement.
4.Q:How can I get some samples?
A: We are honored to offer you some free samples.
5.Q:How does your factory do regarding quality control?
A:"Quality is priority. We always attach great importance to quality controlling from the very beginning to the very end. Our factory has gained FSC, ISO13485 and most products have the CE and FDA certificates.
Contact us
China Export Advanced Quality Rapid HBsAg Test Strip