Intended Use

The HIV(1/2/O), HBsAg and HCV Combo Rapid Test(Serum/Plasma/Whole blood) is a rapid visual immunoassay for the qualitative, presumptive detection of anti-HCV antibodies, HBsAg, and anti-HIV antibodies in human whole blood, serum or plasma specimens. HCV and HBsAg and HIV 3 in 1 Rapid Test is intended for use as an aid in the diagnosis of HCV, HBV and HIV infections.
HIV is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virus is surrounded by a lipid envelope that is derived from host cell membrane. Several viral glycoproteins are on the envelope. Each virus contains two copies of positive-sense genomic RNAs. HIV 1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy people with high potential risk for developing AIDS. HIV 2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals.Both HIV 1 and HIV 2 elicit immune response. Detection of HIV antibodies in serum or plasma is the most efficient and common way to determine whether an individual has been exposed to HIV and to screen blood and blood products for HIV. Despite the differences in their biological characteristics, serological activities and genome sequences, HIV 1 and HIV 2 show strong antigenic cross-reactivity. Most HIV 2 positive sera can be identified by using HIV 1 based serological tests.
Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus, Hepatitis B virus (HBV) or Hepatitis C virus. The complex antigen found on the surface of HBV is called HBsAg. Previous designations included the Australia or Au antigen. The presence of HBsAg in serum, plasma or whole blood is an indication of an active Hepatitis B infection, either acute or chronic. 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. Hepatitis C Virus is a small, enveloped, positive-sense, single-stranded RNA Virus. HCV is now known to be the major cause of parenterally transmitted non-A, non-B hepatitis. Antibody to HCV is found in over 80% of patients with well-documented non-A, non-B hepatitis. Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens. Compared to the first generation HCV EIAs using single recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross-reactivity and to increase the sensitivity of the HCV antibody tests. The HIV(1/2/O), HBsAg and HCV Combo Rapid Test(Serum/Plasma/Whole blood) is a rapid visual immunoassay for the qualitative, presumptive detection of anti-HCV antibodies, HBsAg, and anti-HIV antibodies in human whole blood, serum or plasma specimens. HCV and HBsAg and HIV 3 in 1 Rapid Test is intended for use as an aid in the diagnosis of HCV, HBV and HIV infections. The HIV 1/2 Rapid Test Cassette (Serum/Plasma/Whole blood) is a rapid test to qualitatively detect the presence of Hepatitis B surface antigen (HBsAg), antibodies to Hepatitis C Virus and antibodies to HIV type 1, type 2 and subtype O in Whole blood, serum or plasma.The HIV(1/2/O), HBsAg and HCV Combo Rapid Test(Serum/Plasma/Whole blood) detects anti-HCV antibodies, HBsAg, and anti-HIV antibodies through visual interpretation of color development on the internal strip. Recombinant HCV antigen, anti-HBsAg antibody, and recombinant HIV antigen are immobilized in the test region of HCV, HBsAg and HIV respectively on the membrane.During testing, the specimen and then buffer reacts with mixture of recombinant HCV antigen conjugate, anti-HBsAg antibody conjugate and recombinant HIV antigen conjugate precoated onto the sample pad of the assay. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there is enough target antigen or antibody in the specimen, a colored band will form at the each test region on the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The HIV(1/2/O), HBsAg and HCV Combo Rapid Test(Serum/Plasma/Whole blood) detects anti-HCV antibodies, HBsAg, and anti-HIV antibodies through visual interpretation of color development on the internal strip. Recombinant HCV antigen, anti-HBsAg antibody, and recombinant HIV antigen are immobilized in the test region of HCV, HBsAg and HIV respectively on the membrane.During testing, the specimen and then buffer reacts with mixture of recombinant HCV antigen conjugate, anti-HBsAg antibody conjugate and recombinant HIV antigen conjugate precoated onto the sample pad of the assay. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there is enough target antigen or antibody in the specimen, a colored band will form at the each test region on the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
Specification
| Read time | 10-20 min |
|
Shelf life |
36 months |
| Store temperature | 2-30℃ |
| Operation temperature | 15-30℃ |
| Sensitivity | 99.9%(HIV)/100.0%(HCV)/100.0%(HBsAg) |
| Specificity | 99.3%(HIV)/99.6%(HCV)/100.0%(HBsAg) |
| Accuracy | 99.5%(HIV)/99.4%(HCV)/100.0%(HBsAg) |
Why To Test
1. Why is a Triple (HIV/HBV/HCV) Combo Test Important?
HIV, HBV, and HCV are three serious blood-borne pathogens. They share similar transmission routes-primarily through contact with infected blood, unprotected sexual contact, and from mother to child during pregnancy or delivery. A significant challenge is that infections can present with lengthy asymptomatic periods, meaning individuals may unknowingly carry and transmit the virus for years without showing clear signs. This makes proactive screening crucial .
Using a triple rapid test allows for the simultaneous initial screening of all three viruses from a single sample. This integrated approach significantly enhances screening efficiency, saving time and resources compared to conducting three separate tests. It is particularly valuable in settings like emergency departments, pre-operative assessments, and public health screening programs for high-risk populations, enabling quicker identification of infected individuals and facilitating timely intervention and referral for confirmatory testing .
2. What are HIV, HBV, and HCV?
- HIV (Human Immunodeficiency Virus): HIV attacks and weakens the body's immune system by destroying specific white blood cells. Without effective treatment, the immune system becomes severely compromised, making the individual susceptible to opportunistic infections and certain cancers, a stage known as AIDS .
- HBV (Hepatitis B Virus): HBV causes an infection that inflames the liver. While some healthy adults can clear the virus acutely, others develop a chronic infection that can lead to serious long-term health issues, including cirrhosis (scarring of the liver) and liver cancer. A safe and effective vaccine is available to prevent HBV infection .
- HCV (Hepatitis C Virus): HCV also primarily causes liver inflammation. Unlike HBV, most HCV infections become chronic. However, highly effective direct-acting antiviral (DAA) medications are now available that can cure over 95% of people with chronic HCV infection .
3. How are these viruses transmitted and what are the symptoms?
The viruses are transmitted through contact with infected body fluids .
- HIV: Transmission occurs through unprotected sexual contact, sharing needles or syringes, transfusion with contaminated blood products, and from mother to child during pregnancy, childbirth, or breastfeeding. Early symptoms may resemble the flu (fever, fatigue, swollen glands), followed by a long period with few or no symptoms. Without treatment, it progresses to AIDS, characterized by severe illness .
- HBV: Spread via contact with infected blood or body fluids, including through sexual contact, sharing personal items like razors, from mother to child, and through unsafe medical procedures. Acute infection can cause fatigue, nausea, abdominal pain, and jaundice (yellowing of skin and eyes). Many chronic carriers may feel perfectly healthy for years while the virus damages the liver .
- HCV: Primarily spread through direct blood-to-blood contact (e.g., sharing needles, unsafe injection practices, transfusion before routine screening). Sexual and mother-to-child transmission are less common. Acute infection is often mild or asymptomatic. Chronic infection typically progresses silently for decades until symptoms of advanced liver disease, such as fatigue and jaundice, appear .
4. Who is recommended to use this triple test?
Based on the shared transmission characteristics, combined screening is particularly advised for :
- Individuals with potential exposure risks: Those with a history of unprotected sex, multiple sexual partners, or men who have sex with men; people who inject drugs or have shared needles; and individuals with a history of other sexually transmitted infections (STIs).
- Patients undergoing medical procedures: Individuals scheduled for surgery, organ transplantation, or those requiring blood transfusions, to ensure patient and healthcare worker safety.
- Routine health screenings: Pregnant women during prenatal check-ups, and as part of occupational health screenings for professionals in certain fields (e.g., healthcare).
- Other at-risk groups: Individuals born in or travelers to regions with high prevalence of these viruses.
5. What should I do if the test result is positive?
It is crucial to understand that a reactive (positive) result from a rapid test is a preliminary indication and must be confirmed with more specific supplemental tests performed in a laboratory . If you receive a reactive result, you should:
Consult a healthcare professional immediately. They will guide you on the necessary steps for confirmatory testing.Do not panic. A preliminary positive result requires confirmation.Follow medical advice. Until a confirmed diagnosis is received, a healthcare provider can offer support and information on next steps, which may include further testing and counseling.
Test Method

POSITIVE: * Two distinct colored lines appear. One line should be in the control region (C) and another line should be in the test region (T).
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of HIV antibodies present in the specimen. Therefore, any shade of colored in the test region (T) should be considered positive.
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Catalog
|
Product Name |
Model |
Catalog Number |
Components |
Sample Type |
Strip Type |
|
The HIV(1/2/O), HBsAg and HCV Combo Rapid Test(Serum/Plasma/Whole blood) |
FS13-102 |
FS13-102-1 |
Test Cassettes Disposable specimen droppers Package insert Buffers |
Serum/Plasma/Whole blood |
Cassette |
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