A rapid test for the qualitative detection of Hepatitis B surface
antigen(HBsAg),antibodies to Hepatitis C Virus, antibodies to HIV
type 1, type 2 and syphilis- antibodies (IgG and IgM) to Treponema
Pallidum (TP)in serum or plasma CE certified
The HBsAg /HCV /HIV /Syphilis Combo Rapid Test Cassette(Serum
/Plasma) is a rapid chromatographic immunoassay for the qualitative
detection of Hepatitis B surface antigen(HBsAg),antibodies to
Hepatitis C Virus, antibodies to HIV type 1, type 2 and syphilis
antibodies (IgG and IgM) to Treponema Pallidum (TP) in serum or plasma.
The HBsAg Rapid Test (Serum /Plasma) is a rapid test to qualitatively detect the presence of HBsAg in
serum or plasma specimen. The test utilizes a combination of
monoclonal and polyclonal antibodies to selectively detect elevated
levels of HBsAg in serum or plasma.
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.1The presence of HBsAg in serum or plasma 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.
The HCV Rapid Test (Serum /Plasma) is a rapid test to qualitatively detect the presence of antibody
to HCV in a serum or plasma specimen. The test utilizes colloid
gold conjugate and recombinant HCV proteins to selectively detect
antibody to HCV in serum or plasma. The recombinant HCV proteins
used in the test kit are encoded by the genes for both structural
(nucleocapsid) and non-structural proteins.
Hepatitis C Virus (HCV) 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
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.2,3Compared 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.4,5
The HIV 1.2 Rapid Test (Serum /Plasma) is a rapid test to qualitatively detect the presence of antibody
to HIV 1 and/or HIV 2 in whole blood, serum or plasma specimen. The
test utilizes latex conjugate and multiple recombinant HIV proteins
to selectively detect antibodies to the HIV 1.2 in serum or plasma.
HIV is the etiologic agent of Acquired Immune Deficiency Syndrome
(AIDS). The virion 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.6 HIV 2 has been isolated from West African AIDS patients and from
seropositive asymptomatic individuals.7 Both HIV 1 and HIV 2 elicit immune response.8 Detection of HIV antibodies in serum, 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.9 Despite the differences in their biological characteristics,
serological activities and genome sequences, HIV 1 and HIV 2 show
strong antigenic cross-reactivity.10,11Most HIV 2 positive sera can be identified by using HIV 1 based
The Syphilis Rapid Test (Serum /Plasma)utilizes a double antigen combination of a Syphilis antigen coated
particle and Syphilis antigen immobilized on membrane to detect TP
antibodies (IgG and IgM) qualitatively and selectively in serum or
Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a
spirochete bacterium with an outer envelope and a cytoplasmic
membrane.12Relatively little is known about the organism in comparison with
other bacterial pathogens. According to the Center for Disease
Control (CDC), the number of cases of Syphilis infection has
markedly increased since 1985.13Some key factors that have contributed to this rise include the
crack cocaine epidemic and the high incidence of prostitution among
drug users. One study reported a substantial epidemiological
correlation between the acquisition and transmission of the HIV
virus and Syphilis.
Multiple clinical stages and long periods of latent, asymptomatic
infection are characteristic of Syphilis. Primary Syphilis is
defined by the presence of a chancre at the site of inoculation.
The antibodies response to the TP bacterium can be detected within
4 to 7 days after the chancre appears. The infection remains
detectable until the patient receives adequate treatment.14
How to use?
Allow test cassette, specimen, and/or controls to equilibrate to
room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove
the test cassette from the sealed pouch and use it as soon as
possible. Best results will be obtained if the assay is performed
within one hour.
2. Place the test cassette on a clean and level surface. Hold the
dropper vertically and transfer 2 drops of serum or plasma
(approximately 50mL) to the specimen area, then add 1drop of buffer
(approximately 40mL), respectively. Start the timer. See the
3. Wait for the colored line(s) to appear. The test result should
be read at 10 minutes. Do not interpret the result after 20
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE: * Two distinct colored lines appear. One color line should be in
the control region (C) and another color line should be in the test
*NOTE: The intensity of the color in the test line region (T) will vary
depending on the concentration of HCV antibodies present in the
specimen. Therefore, any shade of red in the test region should be
NEGATIVE: One color line appears in the control region (C). No apparent red
or pink 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.
Internal procedural controls are included in the test. A color line
appearing in the control region (C) is an internal positive
procedural control. It confirms sufficient specimen volume and
correct procedural technique.
Control standards are not supplied with this kit; however, it is
recommended that positive and negative controls be tested as a good
laboratory practice to confirm the test procedure and to verify
proper test performance.