A self-diagnostic test for Hepatitis B infection. 

Our hepatitis B test kit is a convenient and accurate option for testing for this common liver infection in the privacy of your own home. The kit comes with everything you need, including a finger-prick test and a dropper for transferring a sample to the testing strip. Simply follow the instructions provided and wait for your results, which are available in just minutes. This test is highly accurate and provides reliable results, giving you the information you need to seek treatment and protect your health. Whether you are looking to take control of your sexual health or have been experiencing symptoms, our hepatitis B test kit is an effective option.

The Parsagen Home Hepatitis B Test Kit offers you a discreet method of Hepatitis B testing at your own convenience. This is the exact test kit that is being used in government clinics and test labs. Each pack contains a cassette, micro pipette, alcohol preparation pad, diluent bottle (chemical), lancet (needle) and silicon gel (for keeping contents dry).

Product summary

• Detects hepatitis B surface antigen (HBsAG).
• High clinical accuracy. Specificity: 98.8% sensitivity: 98.9%.
• Detection limit of HBsAg is 2.5 ng/ml
• For field & health care professional use.
• Tested by certified laboratories worldwide.
• ISO 13485 & GMP certifications.
• Over 98% accuracy
• TÜV ISO 13485 (ISO’s International Medical Devices Standard) Certified
• GMP (Good Manufacturing Practices) Certified
• Easy to Use
• Total Privacy

Product Description

CATALOG

Product Name	Specimen	Catalog No.	Quantity per box
HBcAb Cassette	Serum/Plasma	PS-D-0110	25T

KEY POINTS

Detection for: Hepatitis B Core Antibody (HBcAb) in serum or plasma;

Specimen volume: 75 μL;

Reading time: 15 minutes;

Relative Sensitivity: 96.9% (95%CI*: 94.4%-98.5%)

Relative Specificity: 96.8% (95%CI*: 92.6%-98.9%)

Accuracy: 97.0% (95%CI*: 95.0%-98.3%)

INTRODUCTION

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 core antibody is a viral protein secreted by HBV infected cells. Its presence indicates high levels of virus in the blood, and it is an indicator of the infectiousness of the carrier. If this test is negative, but a person is known to be HBcAb positive, then it indicates low levels of virus in the blood or an “integrated phase” of HBV in which the virus is integrated into the host’s DNA.

INTENDED USE

Parsagen^® 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.

TEST PROCEDURE

Allow test cassette, serum or plasma specimen, and/or controls to equilibrate to room temperature (15-30℃) prior to testing.

1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the assay is performed immediately after opening the foil pouch.

2. Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 μL) to the specimen well of test device and start the timer. Avoid trapping air bubbles in the specimen well. See illustration below.

3. Wait for the colored line is appeared. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

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

Method		ELISA		Total Results
Parsagen® HBcAb Cassette (Serum/Plasma)	Results	Positive	Negative
	Positive	327	5	332
	Negative	10	150	160
Total Results		337	155	492

Relative Sensitivity: 96.9% (95%CI*: 94.4%-98.5%)

Relative Specificity: 96.8% (95%CI*: 92.6%-98.9%)

Accuracy: 97.0% (95%CI*: 95.0%-98.3%)                                         

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of three specimens containing negative, low positive and high positive. The negative and positive values were correctly identified 99% of the time.

Inter-Assay

Between-run precision has been determined by using the same three specimens of negative, low positive and high positive of HBcAb in 15 independent assays. Three different lots of Parsagen® HBcAb Rapid Test Cassette (Serum/Plasma) has been tested over a 3-month period using negative, low positive and high positive specimens. The specimens were correctly identified 99% of the time.

Cross-reactivity

Parsagen^® HBcAb Rapid Test Cassette (Serum/Plasma) has been tested by HAMA, Rheumatoid factor (RF), HAV, Syphilis, HIV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity

Interfering Substances

Parsagen^® HBcAb Rapid Test Cassette (Serum/Plasma) has been tested for possible interference from visibly hemolyzed and lipemic specimens. No interference was observed.

In addition, no interference was observed in specimens containing up to 2,000 mg/dL Hemoglobin, 1000 mg/dL Bilirubin, and 2000 mg/dL human serum Albumin.

LIMITATIONS

1. Parsagen^® HBcAb Rapid Test Cassette (Serum/Plasma) is for in vitro diagnostic use only. This test should be used for the detection of HBcAb in serum or plasma specimen.

2. Parsagen^® HBcAb Rapid Test Cassette (Serum/Plasma) will only indicate the presence of HBcAb in the specimen and should not be used as the sole criteria for the diagnosis of Hepatitis B viral infection.

3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.