The HBsAg Rapid Test item
The HBsAg Rapid Test item is a qualitative,solid phase,two-site sandwich immunoassay for the
detection of HBsAg in serum, plasma or whole blood.The membrane is pre-coated with
anti-HBsAg antibodies on the test line region of the Device.During testing,the serum or plasma
specimen reacts with the particle coated with anti-HBsAg antibodies.The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-HBsAg
antibodies on the membrane and generate a colored line.This test is for in vitro diagnostic use
only, while its absence indicates a negative result. 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. The HCV Rapid Test item
The HCV Rapid Test item is a qualitative, membrane based immunoassay for the detection of antibody to HCV in serum, plasma or whole blood.The membrane is pre-coated with
recombinant HCV antigen on the test line region of the Device. During testing, the serum or plasma specimen reacts with recombinant HCV antigen conjugated colloid gold.The mixture migrates upward on the membrane chromatographically by capillary action to react with
recombinant HCV antigen on the membrane and generate a colored line.Presence of this
colored line indicates a positive result, while its absence indicates a negative result.To serve as a
procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. The HIV 1.2 Rapid Test item
The HIV 1.2 Rapid Test item is a qualitative,membrane based immunoassay for the detection
of antibodies to HIV 1.2 in serum, plasma or whole blood.The membrane is pre-coated with
recombinant HIV antigens.During testing,the serum or plasma specimen reacts with HIV antigen
coated particles in the test Device.The mixture then migrates upward on the membrane
chromatographically by capillary action and reacts with recombinant HIV antigen on the membrane in the test line region.If the specimen contains antibodies to HIV 1 and/or HIV 2, a
colored line will appear in the test line region,indicating a positive result. If the specimen does not contain HIV 1 and/or HIV 2 antibodies,a colored line will not appear in the test line region,
indicating a negative result. 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. The Syphilis Rapid Test item
The Syphilis Rapid Test item is a qualitative membrane strip based immunoassay for the
detection of TP antibodies (IgG and IgM) in serum, plasma or whole blood.In this test procedure, recombinant syphilis antigen is immobilized in the test line region of the strip.After a Serum/ Plasma specimen is placed in the specimen well, it reacts with syphilis antigen coated particles
that have been applied to the specimen pad.This mixture migrates chromatographically along
the length of the test strip and interacts with the immobilized syphilis antigen.If the specimen
contains TP antibodies, a colored line will appear in the test line region indicating a positive
result.The double antigen test format can detect both IgM and IgG in specimens.If the specimen
does not contain TP antibodies,a colored line will not appear in this region indicating a negative
result.To serve as a procedural control,a colored line will always appear at the control line region
indicating that proper volume of specimen has been added and membrane wicking has occurred.
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The HBsAg Rapid Test item The HBsAg Rapid Test item is a qualitative,solid phase,two-site sandwich immunoassay for the detection of HBsAg in serum, plasma or whole blood.The membrane is pre-coated with anti-HBsAg antibodies on the test line region of the Device.During testing,the serum or plasma specimen reacts with the particle coated with anti-HBsAg antibodies.The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-HBsAg antibodies on the membrane and generate a colored line.This test is for in vitro diagnostic use only, while its absence indicates a negative result. 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. The HCV Rapid Test item The HCV Rapid Test item is a qualitative, membrane based immunoassay for the detection of antibody to HCV in serum, plasma or whole blood.The membrane is pre-coated with recombinant HCV antigen on the test line region of the Device. During testing, the serum or plasma specimen reacts with recombinant HCV antigen conjugated colloid gold.The mixture migrates upward on the membrane chromatographically by capillary action to react with recombinant HCV antigen on the membrane and generate a colored line.Presence of this colored line indicates a positive result, while its absence indicates a negative result.To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. The HIV 1.2 Rapid Test item The HIV 1.2 Rapid Test item is a qualitative,membrane based immunoassay for the detection of antibodies to HIV 1.2 in serum, plasma or whole blood.The membrane is pre-coated with recombinant HIV antigens.During testing,the serum or plasma specimen reacts with HIV antigen coated particles in the test Device.The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with recombinant HIV antigen on the membrane in the test line region.If the specimen contains antibodies to HIV 1 and/or HIV 2, a colored line will appear in the test line region,indicating a positive result. If the specimen does not contain HIV 1 and/or HIV 2 antibodies,a colored line will not appear in the test line region, indicating a negative result. 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. The Syphilis Rapid Test item The Syphilis Rapid Test item is a qualitative membrane strip based immunoassay for the detection of TP antibodies (IgG and IgM) in serum, plasma or whole blood.In this test procedure, recombinant syphilis antigen is immobilized in the test line region of the strip.After a Serum/ Plasma specimen is placed in the specimen well, it reacts with syphilis antigen coated particles that have been applied to the specimen pad.This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized syphilis antigen.If the specimen contains TP antibodies, a colored line will appear in the test line region indicating a positive result.The double antigen test format can detect both IgM and IgG in specimens.If the specimen does not contain TP antibodies,a colored line will not appear in this region indicating a negative result.To serve as a procedural control,a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.