HBcAb ELISA Test Kit
INTENDED USE
The purpose of the HBcAb ELISA Test is intended for the qualitative detection of antibodies to hepatitis B virus Core
antigen in human serum/plasma.
The TP Ab ELISA is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of antibodies to
T.pallidum in human serum or plasma. It is intended for screening blood donors and diagnosing patients related to
infection with T.pallidum virus.
Summary
As part of the Hepadnaviridae family, HBV is an enveloped, double-stranded DNA virus that is a primary cause of
hepatitis transmission through blood. The effects of HBV infection range anywhere from mild to severe hepatitis, which
includes chronic liver problems, such as carcinoma and cirrhosis. In order to classify hepatitis B infection, the
serological markers need to be identified during the three phases of the infection - incubation, acute, and convalescent.
The main component of the virus is Hepatitis B core antigen (HBcAg). This core antigen is comprised of a single
polypeptide of approximately 17kD that is discharged upon disaggregation of the core particles. At least one
immunological determinant is present in the antigen. Shortly after the onset of HBsAg, antibodies to HBcAg (anti-HBc
total antibody and IgM) appear and never go away. In isolated cases, a Hepatitis B infection can be contracted without
immunologically detectable anti-HBc. This is found usually in immunosuppressed patients. Screening for anti-HBc
yields data on the prevalence of hepatitis B in various populations. This is because anti-HBc is a marker of acute,
chronic, or resolved HBV infection. The identification of anti-HBc is vital when being diagnosed in a clinical setting.
Together with other hepatitis B tests, the anti-HBc marker allows correct diagnosis and proper monitoring of progress
of the virus. Anti-HBc may possibly be the only indicator of a hepatitis B infection (including other tests of HBsAg
negative patients).
| Product details |
Description |
| Delivery |
Within 48 hours |
| Packaging Specifications |
8 x 12 strips, 96 wells |
| Country Of Origin |
China |
| Manufacturer |
18 months |
| Preservation method |
2℃-8℃ |
| Specimen |
Whole blood |
| Assification |
class1 |
| Type |
HBcAb ELISA Test Kit |
STORAGE AND STABILITY
The components of the kit will remain stable through the expiration date indicated on the label and package when
stored between 2-8°C, do not freeze. To assure maximum performance of this ELISA kit, during storage, protect the
reagents from contamination with microorganism or chemicals.
PRECAUTIONS AND SAFETY
TO BE USED ONLY FROM QUALIFIED PROFESSIONALS
The ELISA assays are time and temperature sensitive. To avoid incorrect result, strictly follow the test procedure
steps and do not modify them.
1. Do not exchange reagents from different lots or use reagents from other commercially available kits. The
components of the kit are precisely matched for optimal performance of the tests.
2. Make sure that all reagents are within the validity indicated on the kit box and of the same lot. Never use reagents
beyond their expiry date stated on labels or boxes.
3. CAUTION - CRITICAL STEP: Allow the reagents and specimens to reach room temperature (18-30°C) before use.
Shake reagent gently before use. Return at 2-8°C immediately after use.
4. Use only sufficient volume of sample as indicated in the procedure steps. Failure to do so, may cause in low
sensitivity of the assay.
5. Do not touch the bottom exterior of the wells; fingerprints or scratches may interfere with the reading. When reading
the results, ensure that the plate bottom is dry and there are no air bubbles inside the wells.
6. Never allow the microplate wells to dry after the washing step. Immediately proceed to the next step. Avoid the
formation of air bubbles when adding the reagents.
7. Avoid assay steps long time interruptions. Assure same working conditions for all wells.
8. Calibrate the pipette frequently to assure the accuracy of samples/reagents dispensing. Use different disposal
pipette tips for each specimen and reagents in order to avoid cross-contaminations.
9. Assure that the incubation temperature is 37°C inside the incubator.
10. When adding specimens, do not touch the well’s bottom with the pipette tip.
11. When measuring with a plate reader, determine the absorbance at 450nm or at 450/630nm.
12. The enzymatic activity of the HRP-conjugate might be affected from dust and reactive chemical and substances
like sodium hypochlorite, acids, alkalis etc. Do not perform the assay in the presence of these substances.
13. If using fully automated equipment, during incubation, do not cover the plates with the plate cover. The tapping out
of the remainders inside the plate after washing, can also be omitted.
14. All specimens from human origin should be considered as potentially infectious. Strict adherence to GLP (Good
Laboratory Practice) regulations can ensure the personal safety.
15. WARNING: Materials from human origin may have been used in the preparation of the Negative Control of the kit.
These materials have been tested with tests kits with accepted performance and found negative for antibodies to
HIV 1/2, HCV, TP and HBsAg. However, there is no analytical method that can assure that infectious agents in the
specimens or reagents are completely absent. Therefore, handle reagents and specimens with extreme caution
as if capable of transmitting infectious diseases. Bovine derived sera have been used for stabilizing of the positive
and negative controls. Bovine serum albumin (BSA) and fetal calf sera (FCS) are derived from animals from
BSE/TSE free-geographical areas.
16. Never eat, drink, smoke, or apply cosmetics in the assay laboratory. Never pipette solutions by mouth.
17. Chemical should be handled and disposed of only in accordance with the current GLP (Good Laboratory Practices)
and the local or national regulations.
18. The pipette tips, vials, strips and specimen containers should be collected and autoclaved for not less than 2 hours
at 121°C or treated with 10% sodium hypochlorite for 30 minutes to decontaminate before any further steps of
disposal. Solutions containing sodium hypochlorite should NEVER be autoclaved. Materials Safety Data Sheet
(MSDS) available upon request.
19. Some reagents may cause toxicity, irritation, burns or have carcinogenic effect as raw materials. Contact with the
skin and the mucosa should be avoided but not limited to the following reagents: Stop solution, the Chromogens,
and the Wash buffer.
20. The Stop solution 0.5M H2SO4 is an acid. Use it with appropriate care. Wipe up spills immediately and wash with
water if come into contact with the skin or eyes.
21. ProClinTM 300 0.1% used as preservative, can cause sensation of the skin. Wipe up spills immediately or wash
with water if come into contact with the skin or eyes.
INDICATIONS OF INSTABILITY DETERIORATION OF THE REAGENT: Values of the Positive or Negative controls,
which are out of the indicated quality control range, are indicators of possible deterioration of the reagents and/or
operator or equipment errors. In such case, the results should be considered as invalid and the samples must be
retested. In case of constant erroneous results and proven deterioration or instability of the reagents, immediately
substitute the reagents with new one.
PROCEDURE
Reagents preparation: Allow the reagents to reach room temperature (18-30°C). Dilute the Wash buffer (20X) as
indicated in the instructions for washing. Use distilled or deionized water and only clean vessels to dilute the buffer. All
other reagents are READY TO USE AS SUPPLIED.
1. Preparation: Format the microplate’s wells for control and patient specimen to be assayed. Replace any unused
microwell strips back into the aluminum bag seal and store at 2-8°C.
2. Adding Sample: Add 50μl of the control or the samples into the assigned well.
3. Adding Conjugate: Add 50μl of CONJUGATE into each well except the Blank.
4. Incubating: Cover the plate with the plate cover and incubate for 30 minutes at 37°C.
5. Washing: At the end of the incubation, remove and discard the plate cover. Wash each well 5 times with diluted
Wash Buffer. Each time allow the microwells to soak for 30-60 seconds. After the final washing cycle, turn down
the plate onto blotting paper or clean towel and tap it to remove any remainders.
6. Adding Substrate: Add 50μl of Substrate Solution A and 50μl of Substrate Solution B into each well. Incubate for
10 minutes at 37°C avoiding light.
7. Adding Stop Solution: Using a multichannel pipette or manually, add 50μl of Stop Solution into each well and
mix gently.
8. Measuring the Absorbance: Calibrate the plate reader with the Blank well and read the absorbance at 450nm. If
a dual filter instrument is used, set the reference wavelength at 630nm. Calculate the Cut-off value and evaluate
the results. (Note: read the absorbance within 10 minutes after stopping the reaction).
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