【INTENDED USE】
HBeAg Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of Hepatitis B envelope antigen (HBeAg) in human serum, plasma, or whole blood. This assay provides only a preliminary result. Clinical expertise and professional judgment should be sought to further evaluate the result of the test.
【INTRODUCTION】
HBeAg is the “soluble” or extractable part of the “core” antigen of the hepatitis B virus (HBV). The presence of HBeAg indicates that the virus is actively multiplying and is highly contagious. HBeAg appears in the blood shortly after HBsAg. It stays in the blood for about 3 to 6 weeks after the acute (symptomatic) phase of the disease and may persist for a long time or reappear in the case of active chronic hepatitis. Therefore, the HBeAg test is most often used to indicate the level of contagiousness. It is also useful in monitoring the efficacy of a treatment. A positive (reactive) HBeAg result combined with a negative (non-reactive) anti-HBe result confirms a high degree of contagiousness. When the anti-HBe is also reactive, this means the individual is in the process of healing and is less contagious. A non-reactive HBeAg result (with a reactive anti-HBe result) in a person with hepatitis B indicates that the infection is in its initial phase, before peak replication of the virus. If the anti-HBe is reactive, it may indicate that viral replication is now very low.
【PRINCIPLE】
This product is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing anti-HBeAg antibody conjugated with colloid gold (HBeAg Ab conjugates), 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with non-conjugated HBeAg antibody, and the C band is pre-coated with goat anti-mouse IgG antibody. When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the test cassette. HBeAg, if present in the specimen, will be bound to the anti-HBeAg antibody conjugates. The immunocomplex is then captured on the membrane by the pre-coated non-conjugated HBeAg antibody, forming a burgundy colored T band, indicating a HBeAg positive test result. Absence of the T band suggests a negative result. The test contains an internal control (C band), which should exhibit a burgundy colored band of the immunocomplex of goat anti-mouse IgG /HBeAg Ab-gold conjugate regardless of the presence of colored T band. Otherwise, the test result is invalid and the specimen must be retested with another cassette device
【MAIN CONTENTS】
• Rapid test cassette with desiccant.
• Disposable pipettes
• Buffer
• Package insert
【STORAGE AND STABILITY】
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
【SAMPLE COLLECTION】
• The HBeAg Test is intended for use with human whole blood, serum or plasma specimens only.
• Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated assoon as possible to avoid hemolysis.
• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
• Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.
【DIRECTION OF USE】
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use. 1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour. 2. Using the provided disposable pipette, transfer 1 drop of whole blood, serum or plasma, then add 1 drop of buffer and start the timer. Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window. As the test begins to work, color will migrate across the membrane. 3. Wait for the colored band(s) to appear. The result should be read in 15 minutes. Do not interpret the result after 20 minutes.
【INTERPRETATION OF RESULTS】
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of 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.
【LIMITATIONS】
1. The Test Procedure and the Interpretation of Results sections must be followed closely when testing for the presence of HBeAg in serum, plasma or whole blood from individual subjects. Failure to follow the proceduremaygiveinaccurate results.
2. The HBeAg Test Kit is limited to the qualitative detection of HBeAginhumanserum, plasma or whole blood. The intensity of the test line does not havelinearcorrelation with the HBeAg titer in the specimen.
3. A negative or non-reactive test result does not preclude the possibilityof exposureto or infection with HBV.
4. A negative or non-reactive result can occur if the quantity of HBeAgpresentinthe specimen is below the detection limits of the assay or if the antibodythataredetected are not present during the stage of disease in which a sample is collected.
5. Some specimens containing unusually high titers of heterophile antibodiesorrheumatoid factor may affect expected results.
6. If the symptoms persist and the result from HBeAg Test Kit is nonreactive, itisrecommended to re-sample the patient a few days later or test withanalternativedevice.
7. The results obtained with this test should only be interpreted in conjunctionwithother diagnostic procedures and clinical findings.
【PERFORMANCE CHARACTERISTIC】
Clinical Performance HBeAg Rapid Test vs. EIA:
Relative Sensitivity: 97.50%
Relative Specificity: 99.50%
Overall Agreement: 98.50%
Cross-Reactivity
The HBeAg Rapid Test can detec tPositive Serum of Dengue (10), HAV(10), HCV(10), HIV (10), Syphilis(10), TB (10), H. pylori (10), ANA(6), HAMA(4), RF(≤2,500 IU/ml) (3) and showed no cross-reactivity.
Interference
Common substances (such as pain and fever medication and blood components)mayaffect the performance of the HBeAg Test Kit. This was studied byspikingthesesubstances into three levels of HBeAg standard controls. The results are presentedinthe following table and demonstrate that at the concentrations tested, thesubstancesstudied do not affect the performance of the HBeAg Test Kit.
For further operation or performance details, please refer to final instruction manual.
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