Medical Infectious Disease Blood Tests Strip , HBcAb Blood Test For Bacteria

One Step HBcAb Rapid Diagnostic Test , to detect Hepatitis B Core Antibody ,gold colloidal method

Product Name:

One Step HBcAb Rapid Diagnostic Test Cassette

Intended Use:

The HBcAb Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B Core Antibody (HBcAb) in serum or plasma.

Summary:

Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus (HAV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV). Hepatitis B e antibody is a viral protein secreted by HBV-infected cells. The presence of antibody against hepatitis B viral e antigen is used as an indicator for early HBs antigenemia before the peak of viral replication and early convalescence when HBeAg has declined below detectable levels. It is also useful to confirm a seroconversion. The seroconversion from HBeAg positive to anti-Hbe positive indicates a reduced level of infectious virus because virus replication has decreased. The HBeAbRapid Test Cassette (Serum/Plasma) is a rapid test to qualitatively detect the presence of HBeAb in serum or plasma specimen. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of HBeAb in serum or plasma. This one step test is very sensitive and only takes about 10-20minutes. Test results are read visuallywithout any instrument.

TEST PRINCIPLE

The HBcAb test is immunoassay based on the principle of competitive binding. During testing, the mixture migrates upward on the membrane chromatographically by capillary action. The membrane is pre-coated with anti-HBcAg on the test line region of the strip. During testing, if HBcAb present in the specimen, will compete with particle coated HBcAg antibody for limited amount of anti-HBcAg on the membrane. No line will form in the test region. And a visible colored line will form in the test region if there is no HBcAb in the specimen because all the antibody coated particles will be captured by the antigen coated in the test line region. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

Performance

Sensitivity and Specificity

The HBcAb Rapid Test Cassette (Serum/Plasma) was compared with a leading commercial ELISA HBcAb test, the result show that the HBcAb Rapid Test Cassette (Serum/Plasma) has a high sensitivity and specificity.

Relative Sensitivity: 97.8% (95%CI*: 95.7%-99.1%)

Relative Specificity: 97.7% (95%CI*: 94.1%-99.4%)

Accuracy: 97.8% (95%CI*: 96.1%-98.8%)

*Confidence Intervals

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.