Intended use The one step anti-dengue (igm & igg) tri-line test is a colloidal gold enhanced, rapid immunochromatographic assay for the qualitative detection of antibodies (igm & igg) to dengue virus (dv) in human whole blood, serum or plasma. This test is a screening test, and all positives must be confirmed using an alternate test such as western blot. The test is intended for healthcare professional use only.
INTENDED USE The HCG s/u Gold Rapid Screen Test(RST)is a chromatographic immunoassay for the early detection of human chronic gonadotropin (HCG) in serum/plasma or urine specimens. INTRODUCTION HCG is a glycoprotein hormone secreted by the developing placenta during pregnancy. The concentration of HCG in serum is approximately equal to the concentration in urine. The concentrations of HCG in urine and serum continue to rise during the first trimester of pregnancy to as high as 100,000 mIU/ml. HCG appears in urine shortly after conception, and continues to increase during the early stages of pregnancy, making it an excellent indicator for the detection of pregnancy. PRINCIPLE The membrane of the test device was coated with anti HCG antibodies on the test region and goat anti mouse IgG antibodies on the control region. During the test, urine specimen is allowed to react with the HCG monoclonal antibody-colloid gold conjugate, which was pre-dried on the test strip. The mixture then moves upward on the membrane chromatographically by capillary action. For a positive specimen, the conjugate binds to the HCG forming an antibody-antigen complex. This complex is captured by anti HCG antibody immobilized on the test region (T) and produces a pink color band when HCG concentration is equal to or greater than 25mIU/ml. Absence of this colored band in the test region suggests a negative result. To serve as a procedural control, a colored band at the control region(C) will always appear regardless the presence or absence of HCG. STORAGE The kits should be stored at temperature 4-30°C� the sealed pouch for the duration of the shelf life (24months).
Uncut Sheet H. Pylori (H.P)Ab Rapid Test Package:30sheets/pouch Specimen:Whole Blood/Specimen/Serum INTRODUCTION One Step H. Pylori Ab wb /serum/plasma test is a rapid test for the qualitative detection of antibodies specific to Helicobacter pylori in human serum/plasma and whole blood. In this test kit, the H. pylori antigen â?? colloid gold conjugate and specimen moves along the membrane chromatographically to the test region and forms a visible line as the antigenantibodyantigen gold particle complex forms with high degree of sensitivity and specificity. This one step test only takes about 1015 minutes. Test results are read visually without any instrumentation. SPECIMEN COLLECTION & PREPARATION Both whole blood (with or without anticoagulant), serum and plasma specimens can be used with this assay. Simply follow the standard clinical produres to collect whole blood, serum or plasma specimens. If the specimen cannot be tested on the day of collection, store the serum/plasma specimen in a temperature of 28 ºC for up to 72 hours. Stir and bring the specimens to room temperature before testing. Do not freeze whole blood specimens. Do not freeze and thaw the specimen repeatedly. Attention: Specimens and all materials coming in contact with them should be handling and disposed of as if capable of transmitting infection. Avoid contact with skin by wearing gloves and proper laboratory attire. REAGENTS AND MATERIALS SUPPLIED 1. Test kit 2. Specimen diluents in dropper bottle 3. Plastic dropper to dispense sample
Uncut Sheet Leishmania IgG/IgM Rapid Test Specimen:Whole Blood/ Serum/ Plasma INTENDED USE The Leishmania IgG/IgM Rapid Test is a lateral flow immunoassay for the qualitative detection of antibodies including IgG and IgM to the subspecies of the Leishmania donovani (L. donovani), the Visceral leishmaniasis causative protozoans in human serum or plasma. This test is intended to be used as a screening test and as an aid in the diagnosis of the disease of Visceral leishmaniasis. Any reactive specimen with the Leishmania IgG/IgM Rapid Test must be confirmed with alternative testing method(s). SUMMARY AND EXPLANATION OF THE TEST Visceral leishmaniasis, or Kala-azar, is a disseminated infection caused by several subspecies of the L. donovani. The disease is estimated by the World Health Organization (WHO) to affect approximately 12 million people in 88 countries1. It is transmitted to humans by bites of the Phlebotomus sandflies, which acquire infection from feeding on infected animals. Though it is a disease for poor countries, in Southern Europe, it has become the leading opportunistic infection in AIDS patients2-3. Identification of L. donovani organism from the blood, bone marrow, liver, lymph nodes or the spleen provides a definite means of diagnosis. However, these test methods are limited by the sampling method and the special instrument requirement. Serological detection of anti-L. donovani Ab is found to be an excellent marker for the infection of Visceral leishmaniasis. Tests used in clinic include: ELISA, fluorescent antibody and direct agglutination tests4-5. Recently, utilization of L. donovani specific protein in the test has improved the sensitivity and specificity dramatically6-7. The Leishmania IgG/IgM Rapid Test is a recombinant protein based serological test, which detects antibodies including IgG, IgM and IgA to the L. Donovani. This test provides a reliable result within 10 minutes without any instrumentation requirements.
Uncut Sheet HBsAg Rapid Test Package:30sheets/pouch Specimen:Whole blood/Serum/Plasma FOR THE QUALITATIVE ASSESSMENT OF HBsAg IN HUMAN SERUM, PLASMA OR WHOLE BLOOD INTENDED USE The HBsAg Rapid Test is a Chromatographic immunoassay (CIA) for direct qualitative detection of Hepatitis B type virus surface antigen (HBsAg) in human serum /plasma and whole blood. PRINCIPLE The HBsAg RST is a chromatographic immunoassay (CIA) for the detection of surface antigens of Hepatitis B in human serum/plasma and whole blood. Specific antibody against HBsAg is pre-coated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with anotherr specific antibody. If HBsAg is present, a pink colored band will develop on the membrane in proportion to the amount of HBsAg presented in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence or absence of HBsAg. REAGENTS AND MATERIALS PROVIDED 1.One sealed pouched cassette with desiccant and a disposable pipette.. 2.Blood diluent in a dropper bottle. Store at 2-8°C. 3.One piece of operating instruction with 40 test pouches..
Uncut Sheet HBsAb Rapid Test Package:30sheets/pouch Specimen:Whole Blood/Serum/Plasma FOR THE QUALITATIVE ASSESSMENT OF HBsAb IN HUMANSERUM, PLASMA OR WHOLE BLOOD INTENDED USE Rapid HBsAb Test is a chromatographic immunoassay for qualitative detection of the surface antibody of hepatitis B virus (Anti-HBs) in human whole blood samples. It is intended for use in medical institution as an aid for diagnosis and management of patients related to infection with hepatitis B as well for screening of blood donors or blood products PRINCIPLE Rapid HBsAb Test employs chromatographic lateral flow device. Colloidal gold conjugated surface antigen reactive to anti-HBs (sAg-Au) are dry-immobilized onto a nitrocellulose membrane strip. When the sample is added, it migrates by capillary diffusion through the strip rehydrating the gold conjugate. If present, anti-HBs will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by HBsAg immobilized there and a visible red line appears. If there is no anti-HBs in sample, no red line will appear in the Test Zone (T). The gold conjugate will continue to migrate alone until is captured in the Control Zone (C) from immobilized goat, anti-HBs antibody and aggregating in a red line, which indicates the validity of the test STORAGE Store the test device at 4 to 30°C. Do Not Freeze.
INTENDED USE The HCV Gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Hepatitis C type virus (HCV) in human serum/ plasma and whole blood. PRINCIPLE HCV RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HCV in human serum/plasma and whole blood. HCV recombinant antigens are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HCV recombinant antigens. If antibodies to HCV present, a pink colored band will develop on the membrane in proportion to the amount of HCV antibodies present in the specimen .Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a purple colored band in the control region will always appear regardless the presence of antibodies to HCV. REAGENTS AND MATERIALS PROVIDED 1. One pouched cassette with desiccant. 2. Blood diluent in a dropper bottle, stored at 4-30°C. 3. One piece of operating instruction. WARNING AND PRECAUTIONS 1. For in vitro diagnostic uses only. 2. All patient samples should be treated as if capable of transmitting diseases. 3. Do not interchange reagents from different lots or use test kit beyond expiration date. 4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results. STORAGE The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24 months).
INTENDED USE The HCV Gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Hepatitis C type virus (HCV) in human serum/ plasma and whole blood. PRINCIPLE HCV RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HCV in human serum/plasma and whole blood. HCV recombinant antigens are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HCV recombinant antigens. If antibodies to HCV present, a pink colored band will develop on the membrane in proportion to the amount of HCV antibodies present in the specimen .Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a purple colored band in the control region will always appear regardless the presence of antibodies to HCV. REAGENTS AND MATERIALS PROVIDED 1. One pouched cassette with desiccant. 2. Blood diluent in a dropper bottle, stored at 4-30°C. 3. One piece of operating instruction. WARNING AND PRECAUTIONS 1. For in vitro diagnostic uses only. 2. All patient samples should be treated as if capable of transmitting diseases. 3. Do not interchange reagents from different lots or use test kit beyond expiration date. 4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results. STORAGE The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24 months).
INTENDED USE The HCV Gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Hepatitis C type virus (HCV) in human serum/ plasma and whole blood. PRINCIPLE HCV RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HCV in human serum/plasma and whole blood. HCV recombinant antigens are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HCV recombinant antigens. If antibodies to HCV present, a pink colored band will develop on the membrane in proportion to the amount of HCV antibodies present in the specimen .Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a purple colored band in the control region will always appear regardless the presence of antibodies to HCV. REAGENTS AND MATERIALS PROVIDED 1. One pouched cassette with desiccant. 2. Blood diluent in a dropper bottle, stored at 4-30°C. 3. One piece of operating instruction. WARNING AND PRECAUTIONS 1. For in vitro diagnostic uses only. 2. All patient samples should be treated as if capable of transmitting diseases. 3. Do not interchange reagents from different lots or use test kit beyond expiration date. 4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results. STORAGE The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24 months).
Uncut Sheet HCG Urine/Serum Rapid Test SPECIMEN: Whole Blood/ Serum/ Plasma INTENDED USE The One Step TOXO IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Toxoplasma gondii in Whole Blood /Serum / Plasma to aid in the diagnosis of TOXO infection. Toxoplasma gondii is an obligate intracellular protozoan parasite with a worldwide distribution. Serological data indicates that approximately 30% of the population of most industrialized nations is chronically infected with the organism. A variety of serologic tests for antibodies to Toxoplasma gondii have been used as an aid in diagnosis of acute infection and to assess previous exposure to the organism. These tests are the Sabin-Feldman dye test, direct agglutination, indirect hemagglutination, latex agglutination, indirect immunofluorescence, and ELISA. Recently, lateral flow chromatographic immunoassay, such as The Toxo IgM/IgG Rapid Test (Whole Blood/Serum/Plasma) was introduced into the clinic for the serodiagnosis of Toxoplasma gondii infection. One step TOXO IgG/IgM Test is a simple, visual qualitative test that detects TOXO antibodies in human Whole Blood/serum/plasma. The test is based on immunochromatography and can give a result within 15 minutes. Storage and Stability Store as packaged in the sealed pouch at room temperature or refrigerated (4-30â?? or 40-86â??). The test device is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use.
1. INTENDED USE CDV + CPV Ag Combined Rapid Test is a combined cassette to diagnose the presence of Canine Disteimper virus antigen and Canine Parvovirus antigen in dogâ??s secretions, serum or feces. Assay Time: 5 - 10 min Sample: Secretions, serum or feces 2. PRINCIPLE OF THE ASSAY CDV + CPV Ag Combined Rapid Test is based on sandwich lateral flow immunochromatographic assay. The test device has two testing windows. Each testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough CDV antigen or CPV antigen in the sample, a visible T band will appear in the corresponding testing window. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of CDV antigen or CPV antigen in the sample. 3. KIT COMPONENT - 10Ã?foil pouches each containing a cassette, pipette and desiccant - 10Ã?assay buffer tubes (0.7 mL each) - 10Ã?assay buffer tubes (1.0 mL each) - 20Ã?swab sticks - Product Manual
1. INTENDED USE CPV + CCV +Giardia Ag Triple Test is a combined cassette to differentially diagnose the presence of Canine Parvovirus antigen, Canine Coronavirus antigen and Giardia antigen in dogâ??s feces or vomit. Assay Time: 5-10 min Sample: Feces or vomit 2. PRINCIPLE OF THE ASSAY CPV + CCV + Giardia Ag Triple Test is based on sandwich lateral flow immunochromatographic assay. The test device has three testing windows. Each testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough CPV antigen, CCV antigen or Giardia antigen in the sample, a visible T band will appear in the corresponding testing window. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of CPV, CCV or Giardia antigen in the sample. 3. KIT COMPONENT - 10Ã?foil pouches, each containing onecassette and a desiccant - 10Ã?assay buffer tubes (1.0 mL each) - 10Ã?pipettes - 10Ã?swab sticks - Product Manual
1. INTENDED USE CPV + CCV Ag Combined Test is a combined cassette to differentially diagnose the presence of Canine Parvovirus antigen and Canine Coronavirus antigen in dogâ??s feces or vomit. Assay Time: 5 -10 min Sample: Feces or vomit 2. PRINCIPLE OF THE ASSAY CPV + CCV Ag Combined Test is based on sandwich lateral flow immunochromatographic assay. The test device has two testing windows. Each testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough CPV antigen or CCV antigen in the sample, a visible T band will appear in the corresponding testing window. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of CPV antigen or CCV antigen in the sample. 3. KIT COMPONENT - 10Ã?foil pouches, each containing acassette, pipette and desiccant - 10Ã?assay buffer tubes (1.0 mL each) - 10Ã?swab sticks - Product Manual
Feline Leukemia Test INTENDED USE Feline Leukemia Virus AG Rapid Test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of Feline Leukemia Virus antigen in cat's blood. Assay Time: 5-10 min Sample: Serum,Plasma or Whole Blood Feline Leukemia Test PRINCIPLE Feline Leukemia Virus AG Rapid Test is based on sandwich lateral flow immunochromatographic assay. The test device has a testing window. The testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough feline leukemia virus antigen in the sample, a visible T band will appear. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of feline leukemia virus antigen in the sample. Feline Leukemia Test KIT COMPONENT 1. Foil pouches, each containing one cassette, one pipette and a desiccant 2. Assay buffer (2.0 mL) 3. Centrifugal tubes 4. Product Manual Feline Leukemia Test TEST PROCEDURE 1. Take cat's blood, serum or plasma as sample. 2. Take out the cassette from the foil pouch and place it horizontally. 3. Drip 1 drop of sample and immediately drip 2 - 3 drops of assay buffer into the sample hole "S". 4. Interpret the result in 10-15 minutes. Result after 15 minutes is considered as invalid.
Intended Use The Influenza A +B Test is a rapid chromatographic immunoassay for the qualitative detection of influenza type A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. This kit is intended to be used as an aid in the diagnosis of influenza A and influenza B virus in nasal swab specimens. Principle The Influenza A +B Test is a qualitative membrane strip based immunoassay for the detection of influenza type A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. In this test procedure, influenza type A antibody is immobilized in the A line, influenza type B antibody is immobilized in the B line. After a specimen is placed in the specimen well, it reacts with influenza type A antibody and/or B antibody 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 antibody. If the specimen contains influenza type A, a colored line will appear in the A line region indicating a influenza type A positive result. If the specimen contains influenza type B, a colored line will appear in the B line region indicating a influenza type B positive result. Absence of any T lines (A and B) suggests 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. Storage and Stability 1.Store as packaged in the sealed pouch at room temperature or refrigerated (4-30â?? or 40-86â??). The test device is stable through the expiration date printed on the sealed pouch. 2.The test must remain in the sealed pouch until use.
Specimen:Whole Blood /Serum / Plasma D-Dimer Rapid Test Device is used for the qualitative detection of D-dimer in human whole blood and plasma; The test is used as an aid in the assessment and evaluation of patients with suspected disseminated intravascular coagulation (DIC), deep vein thrombosis (DVT), and pulmonary embolism (PE). During blood coagulation process, fibrinogen is converted to fibrin by the activation of thrombin. The resulting fibrin monomers polymerise to form a soluble gel of non-cross-linked fibrin. This fibrin gel is then converted to cross-linked fibrin by thrombin activated Factor XIII to form an insoluble fibrin clot. Production of plasmin, the major clot-lysing enzyme, is triggered when a fibrin clot is formed. Although fibrinogen and fibrin are both cleaved by the fibrinolytic enzyme plasmin to yield degradation products, only degradation products from cross-linked fibrin contain D-dimer and are called cross-linked fibrin degradation products. Therefore, fibrin derivatives in human blood or plasma containing D-dimer are a specific marker of fibrinolysis. The D-Dimer Rapid Test Device (Whole blood//Plasma) detects D-Dimer through visual interpretation of color development in the internal strip. Anti-D-Dimer antibodies are immobilized on the test region of the membrane, and anti-mouse antibodies immobilized on the control region. During testing, the specimen reacts with anti-D-Dimer antibodies conjugated to colored particles and precoated onto the sample pad of the strip. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient D-Dimer in the specimen, a colored band will form at the test region of 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.
One-Step Adenovirus Ag Rapid Test Formats:Uncut Sheets , Bulk Package, 30Tests/Box ,OEM Specimen:Feces INTENDED USE The Adenovirus Rapid Test Device (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of adenovirus in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of adenovirus infection. INTRODUCTION Acute diarrheal disease in young children is a major cause of morbidity worldwide and is a leading cause of mortality in developing countries. Research has shown that enteric adenoviruses, primarily Ad40 and Ad41, are a leading cause of diarrhea in many of these children, second only to the rotaviruses. These viral pathogens have been isolated throughout the world, and can cause diarrhea in children year round. Infections are most frequently seen in children less than two years of age, but have been found in patients of all ages. Further studies indicate that adenoviruses are associated with 4-15% of all hospitalized cases of viral gastroenteritis. Rapid and accurate diagnosis of gastroenteritis due to adenovirus is helpful in establishing the etiology of gastroenteritis and related patient management. Other diagnostic techniques such as electron microscopy (EM) and nucleic acid hybridization are expensive and labor-intensive. With the self-limiting nature of adenovirus infection, such expensive and labor-intensive tests may not be necessary.
The Chagas Ab Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with T. cruzi. Any reactive specimen with the Chagas Ab Rapid Test must be confirmed with alternative testing method(s) and clinical findings. Chagas disease is an insect-borne, zoonotic infection by the protozoan T. cruzi, which causes a systemic infection of humans with acute manifestations and long term sequelae. It is estimated that 16-18 million individuals are infected worldwide, and roughly 50,000 people die each year from chronic Chagas disease (World Health Organization)1. Buffy coat examination and xenodiagnosis used to be the most commonly methods2,3 in the diagnosis of acute T. cruzi infection. However, both methods are either time consuming or lack of sensitivity. Recently, serological test becomes the mainstay in the diagnosis of Chagasâ??s disease. In particularly, recombinant antigen based tests eliminate false-positive reactions which are commonly seen in the native antigen tests4-5. The Chagas Ab Rapid Test is an instant antibody test which detects IgG antibodies the T. cruzi within 15 minutes without any instrument requirements. By utilizing T. cruzi specific recombinant antigen, the test is highly sensitive and specific.
INTENDED USE The neisseria gonorrhoeae antigen test card is a rapid visual immunoassay for the qualitative detection of neisseria gonorrhoeae in female endocervical swab and male urethral swab specimens. This kit is intended for use as an aid in the diagnosis of neisseria gonorrhoeae infection. PRINCIPLE The neisseria gonorrhoeae antigen test kit is designed to detect N. Gonorrhoeae through visual interpretation of the color development in the internal strip. The membrane was immobilized with gonococcal Antigen-specific polychonal antibody on the test region (T) and related antibodies on the control region(C). During testing, the specimen is added to the sample region (S) and reacts with anti-gonococcus antibodies conjugated to colored particles and precoated onto the sample pad of the test. Then, the mixture migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient gonococcus antigens in the specimen, a colored band will form at the test region (T) of 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.
INTENDED USE The One Step RV IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Rubella (Virus) in Whole Blood /Serum / Plasma to aid in the diagnosis of RV infection. The test is based on immunochromatography and can give a result within 15 minutes. PRINCIPLE The One Step RV IgG/IgM Test is a qualitative membrane strip based immunoassay for the detection of RV antibodies (IgG and IgM) in Whole Blood /Serum / Plasma. The test device consists of: 1) a burgundy colored conjugate pad containing RV recombinant envelope antigens conjugated with Colloid gold (RV conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with the antibody for the detection of IgM anti-RV, T2 band is coated with antibody for the detection of IgG anti-RV, and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG anti-RV, if present in the specimen, will bind to the RV conjugates. The immunocomplex is then captured by the reagent pre-coated on the T2 band, forming a burgundy colored T2 band, indicating a RV IgG positive test result and suggesting a recent or repeat infection. IgM anti-RV if present in the specimen will bind to the RV conjugates. The immunocomplex is then captured by the reagent coated on the T1 band, forming a burgundy colored T1 band, indicating a RV IgM positive test result and suggesting a fresh infection. Absence of any T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device. Storage and Stability Store as packaged in the sealed pouch at room temperature or refrigerated (4-30â?? or 40-86â??). The test device is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use.
