One-Step HBsAg Rapid Test is to detect the Hepatitis B Virus Surface Antigen in serum, plasma or whole blood.
Analytical sensitivity : 1ng/ml of HBsAg
Sensitivity :100% , Specificity : 100%
Specimen : Serum , Plasma or Whole Blood
Reading Time : 10 min
The HIV-1/2 Rapid Screen Test (RST) is a qualitative test for the detection of antibodies to Human Immunodeficiency Virus type 1 and 2(HIV-1/2) in human serum/plasma and whole blood. It is considered as an initial screening test for HIV-1/2 antibodies. All positive specimens must be confirmed with Western Blot or other qualified EIA.
PRECAUTION
1.For in vitro diagnostic uses only.
2.All patient samples should be treated as if capable of transmitting diseases.
3.Do not use test kit beyond expiration date.
4.Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.
SUMMARY AND EXPLANATION OF THE TEST
It has been shown that the acquired immunodeficiency syndrome (AIDS) is caused by viruses transmitted by sexual contact, transfusion, use of contaminated blood products and sharing contaminated needles. HIV-1 and HIV-2 viruses have been isolated from patients with AIDS and AIDS-related complex (ARC), high-risk persons for AIDS. HIV-1 and HIV-2 viruses delete T helper cells, a subpopulation of T cells for body defense, thus causing AIDS patients susceptible to opportunistic infections and developing malignant tumors. The incidence of specific antibodies to HIV-1/2 is high in AIDS, ARC and persons with high risk for AIDS. The HIV-1/2 Rapid Screen Test is designed to detect antibodies to HIV-1/2 in AIDS patients, ARC or high risk persons and identify any potential donors carrying these antibodies in serum specimens.
PRINCIPLE
HIV-1/2 RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HIV-1/2 in human serum/plasma and whole blood. HIV-1/2 specific 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 HIV-1/2 specific antigens. Antibodies to HIV-1/2, if present, a red colored band will develop on the membrane in proportion to the amount of HIV-1/2 antibodies present in the specimen. Absence of this red colored band in the test region suggests a negative result. To serve as a procedural control, red colored band in the control region will always appear regardless the presence of antibodies to HIV-1/2.
INTENDED USE
Canine Distemper Virus Ag Test is a sandwich lateral flow immunochromatographic assay for the qualitative
detection of canine Distemper virus (CDV Ag) in dog's secretions or serum.
Assay Time: 5-10 min
Sample: secretions or serum
PRINCIPLE
Canine Distemper Virus Ag 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 Distemper 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 Canine Distemper antigen in the sample.
Package: in bulk or unit box package for your options
Delivery date:7-10 days after receipt of the payment
Pouch design: white pouch / netrual/ OEM design/CE Marked
Payment:Westren Union,T/T
Packing Specifications
The kit is an in vitro immunochromatographic assay for the qualitative detection of Cov19, Influenza A and Influenza B virus antigens in human nasopharyngeal, oropharyngeal swab, and salvia samples.
Cov19 is an acute respiratory infectious disease that humans are easily infected with. According to current epidemiological investigations, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main symptoms are: fever, fatigue, dry cough, in a few cases can appear nasal congestion, sore throat, myalgia and diarrhea. Influenza, often called the flu is caused by the influenza virus. It is a highly contagious viral infection of the respiratory tract that can be spread by coughing or sneezing. Influenza outbreaks occur every fall and winter. There are influenza A, B and C viruses. Influenza A viruses are more prevalent than influenza B and Cand causes more severe illness.
Cov19 infection and Influenza virus infection have similar symptoms, such as fever, cough, etc. This kit can simultaneously detect the antigens of the three viruses and provides an easy workflow, short turnaround time, and rapid diagnosis of Cov19, Influenza A and influenza B virus infections using nasopharyngeal, oropharyngeal swab or salvia samples.
The kit is an immunochromatographic assay,based on double antibody sandwich method to detect Cov19 and Influenza A/B virus antigens. This method does not require expensive medical instruments and consumables. After adding the extracted specimen to the sample well on the test cassette, Cov19, Influenza A/B virus antigens in the sample will interact with the colloidal gold-labeled anti-CoV-2 and Influenza A/B antibodies on the conjugate pads. Then the conjugate pad will release re-solubilized conjugate onto the nitrocellulose membrane. The nitrocellulose membrane (NC membrane) diffuses it forward.
As the sample moves along the device binding reagents situated on the nitrocellulose membrane bind to the target at the test line. If the sample contains a COV19 antigen, it will bind to the colloidal goldanti-CoV-2 Np monoclonal antibody, diffuse forward, and then react with the anti-CoV-2 Np monoclonal antibody immobilized on the NC membrane detection line (COV19 Test line). Similarly, if the specimen contains Influenza A/Influenza B antigens, the antigens will react with antibody-coated particles, the conjugate migrate laterally forward, and cause a colored lines (A, B linesrespectively).
Product Name
Neutrophil Gelatinase-Associated Lipid Carrier Protein (NGAL)Test Kit (Immunofluorescence Chromatography)
Purpose
To detect the NGAL in human plasma/serum/whole blood in vitro quantitatively.For Professional Use only.
Principles of Detection
The NGAL Test is a fluorescent lateral flow immunoassay. The test consists of: 1) a conjugate pad containing NGAL antibody conjugated with fluorescent microspheres and a control antibody (goat anti-chicken IgY antibody) conjugated with fluorescence microspheres, 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with anotherNGAL antibody, and the C line is pre-coated with a control line antibody (chicken IgY antibody).
NGAL concentration in specimen is positively correlated with the fluorescent density of the microspheres, after the measure and calculation of the quantitative fluorescence immunoassay analyzer, then the analyzer would calculate the concentration of NGAL according to the preset calibration curve in the machine and display the result, detection unit is ng/mL. C line should appear in any cases, which indicates the reaction system is effective.
Reference range
Reference value: 37-180ng/mL; The reference value is verified by referring to similar products on the market. Due to ethnic and regional differences, each laboratory can establish its own reference interval according to the actual situation.
Antigen Detection Rapid Lateral Flow Test (latex bead-based)
AIVD Biotech's Ag test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein (NP) antigen in direct nasal swabs from individuals suspected of infection.
Description:
This kit utilizes the principle of latex bead immunochromatography to qualitatively detect the Np antigen in human nasal swabs. Lateral flow immunochromatographic assay provides an easy workflow, short turnaround time, and rapid diagnosis of suspected patients.
The test contains latex bead conjugate pad and a membrane strip pre-coated with antibodies specific to the antigen on the test lines (T). If novel NP antigen is present in the specimen, a visible band appears on the test lines (T) as antibody-antigen-antibody latex bead complex forms. The control line (C) is used for procedural control and should always appear if the test is performed correctly.
This method does not require expensive medical instruments and consumables. Just take the specimen and add it to the sample well. If sample contains the antigen, it will interact with the latex bead-labeled anti- NP antibodies on the conjugate pad.
Required components
1. A foil pouch with a desiccant and a single use test card, 1 piece
3. Sterile swab, 1 piece
3. Extraction buffer tube (1 ml), 1 tube.
4. Instructions for use, 1 piece.
Storage conditions
1. Store at the dark place, room temperature 18~28C with low humidity.
2. After opening the foil bag, please use the test cassette within 30 mins.
3. Expiration period 12 month
2.Specimen should be tested as soon as possible upon collection. If the sample has to be stored, store the swab sample at room temperature for up to 1 hour or 2~8C for up to 4 hours prior to testing.
Performance Characteristics
A total of 365 samples from suspected patients were tested by the RT-qPCR test. Testing results are shown in the following table:
PCR
AIVD Antigen Rapid Test Kit Positive Negative
Positive 59 8
Negative 6 292
Total: 65 300
1. Nasopharynx swab specimen, non-invasive
2. Very simple to use
3. Convenient, no devices required
4. Rapid, results within 20 minutes
5. Cost-efficient
6:Listed on German BfArm ,got approval by PEI
Clinical report from local CDC
Sensitivity is 97.14%, Specificity is 100%, total accuracy rate is 99.68%.
Bacterial Vaginosis Rapid Test Kit core Chromogenic Ingredient IBX-4041
IBX-4041 Testing vessel
BV Blue active ingredient
BVBlue active ingredient
BVBlue substrates
BV Blue substrates
Chromogenic substrate IBX-4041
chromogenic substrate of sialidase enzyme
Detection reagent for bacterial vaginosis (sialidase two-step method)
Shenzhen BST Science & Technology Co., Ltd sells and exports chromogenic substrate of sialidase enzyme IBX-4041.
Specification:
Appearance: Light yellow solid powder
Purity: 95% min
Application: Two-step chromogenic substrates of neuraminidase (sialidase)
BVBLUE Test Kit Component
1)BVBLUE Developer Solution: Water and Sodium hydroxide
2) BVBLUE Testing Vessel: Water, Potassium acetate, IBX-4041 (chromogenic substrate compound).
IBX-4041 is the key ingredient of BVBLUE test kit, BVBLUE test is a rapid sialidase test for bacterial vaginosis. BVBLUE test method is currently the only test method approved by the FDA for testing Bacterial Vaginosis(BV), The BV BLUE Test contains a chromogenic substrate of sialidase enzyme, IBX-4041.
BV Blue test is a commercially available test, it detects sialidase activity, an enzyme produced by BV-associated bacteria such as Gardnerella vaginalis, Bacteroides spp., Prevotella spp., and Mobiluncus spp. In the test procedure, a vaginal fluid sample is placed in the test vessel which contains a chromogenic substrate for sialidase. After incubation, a developer solution is added, and If the sample contained a high level of sialidase, a blue or green color is seen. Samples containing no sialidase, or low levels of this enzyme, will generate a yellow color in the reaction. The BV test has high specificity and sensitivity. The BVBlue test enables rapid detection of BV in a physician's office, and can thereby provide advantages over the Amsel methods and other methods requiring extensive laboratory testing.
Advantage of BVBLUE Test Kit
Compared to other diagnostic test methods for BV such as Amsel criteria, Nugent Gram-stain scoring system, Affirm�® Microbial Identification Test, BVBLUE Test Kit has following advantage:
1, BVBLUE Test is currently the only test method approved by the FDA for testing Bacterial Vaginosis(BV).
2, BVBLUE Test just take 10 minutes to 15 minutes to get the result.
3, High purity sialidase substrate with high specificity can reduce the occurrence of false positive.
4. Comparing with the gold standard, the coincidence rate is high, the relative sensitivity is 93%, and the specificity is 95%.
5. Easy to operate, do not need equipment.
6. The specimen does not need to pretreat.
This kit adopts the method of indirect competitive enzyme-linked immunoassay (ELISA) to detect Clenbuterol (CLE) in the sample such as urine, tissue and feed.
Package specification:96wells per kit
This kit is used to detect RBV antigen in saliva secretion of dogs and cats, and can be used for screening of RBV infection and auxiliary diagnosis. test time: 10- 15min
Package specification:20 tests/kit
This kit is using detecting canine parvovirus antigen in canine feces, rectum, vomitus, or saliva. It can be used for screening canine parvovirus infection ,auxiliary diagnosis and so on. Test time:5-10min
The kit uses colloidal gold immunochromatography assay (GICA) to detected antibodies against Brucella in cattle, sheep and goats.
The test duration is 10-15 minutes.
20tests/kit
The kit employs colloidal gold immunochromatography assay (GICA) and is specifically designed for the detection of NDV antigens in avian tracheal and cloacal secretions. It is suitable for screening NDV infections and can also be used as an adjunctive diagnostic tool. The test duration is 10-15 minutes.
Fapon Biotech provide gene engineering recombinant antigens and antibodys of HIV type 1¿¬¿«2 and group O, which can be used in ELISA and Rapid Test Kit, with high sensitive specific and stability.
for Rapid test
HCV Core+NS3+NS4+NS5 (IgG indirect)
HCV Core+NS3+NS4+NS5 (for coating, Sandwich)
HCV Core+NS3+NS4+NS5 (for conjugating, Sandwich)
Fapon Biotech provide gene engineering recombinant antigens of HCV, which can be used in ELISA, Rapid Test Kit and research, with high sensitive specific and stability.
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