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 Specimen requirements: 1. Nasopharyngeal swab specimen. 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 Sensitivity: 90.7%; Specificity: 97.3%.
COV19/ FluA/ FluB Antigen Combo Rapid Test Kit (Colloidal Gold Method) 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.
Product Name Human Chorionic Gonadotropin (HCG) Test Kit (Immunofluorescence Chromatography) Purpose To detect the content of HCG in human plasma/serum/whole blood in vitro quantitatively.For Professional Use only. Principles of Detection The HCG Test is a fluorescent lateral flow immunoassay. The test consists of: 1) a conjugate pad containing HCG 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 another HCG antibody, and the C line is pre-coated with a control line antibody (chicken IgY antibody). HCG 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 HCG according to the preset calibration curve in the machine and display the result, detection unit is mIU/mL. C line should appear in any cases, which indicates the reaction system is effective. Storage conditions and shelf life Store in a sealed aluminum foil bag at 2 - 30 C. After unpacking the aluminum foil bag under temperature 20~30 C , humidity 35~65%, please use it immediately. Shelf life 18 months. Applicable instrument Avid fluorescent immunoanalyzer model: AI-IF 600
Product Name Triiodothyronine (T3) Test Kit (Immunofluorescence Chromatography) Purpose To detect the content of T3 in human plasma/serum/whole blood in vitro quantitatively.For Professional Use only. Principles of Detection The T3 Test is a fluorescent lateral flow immunoassay. The test consists of: 1) a conjugate pad containing T3 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 another T3 antigen, and the C line is pre-coated with a control line antibody (chicken IgY antibody). T3 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 T3 according to the preset calibration curve in the machine and display the result, detection unit is nmol/mL. C line should appear in any cases, which indicates the reaction system is effective. Storage conditions and shelf life Store in a sealed aluminum foil bag at 2~30�°C. After unpacking the aluminum foil bag under temperature 20~30 �ºC , humidity 35~65%, please use it immediately. Shelf life 18 months. Reference range Reference value:The 95% concentrations of T3 in 239 non-stationary subjects without any obvious thyroid dysfunction ranged from 1.34 to 2.73nmol/L, with a median of 1.81nmol/L;The reference value has been verified with reference to similar products already on the market. Each laboratory can build own reference range according to actual situation.
Product Name C-reactive Protein(CRP)Test Kit (Immunofluorescence Chromatography) Purpose To detect the content of CRP in human plasma/serum/whole blood in vitro quantitatively.For Professional Use only. Principles of Detection The CRP Test is a fluorescent lateral flow immunoassay. The test consists of: 1) a conjugate pad containing CRP antibody conjugated with fluorescent microspheres and a control antibody (goat anti-rabbit IgG 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 another CRP antibody, and the C line is pre-coated with a control line antibody (rabbit IgG antibody). CRP 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 CRP according to the preset calibration curve in the machine and display the result, detection unit is mg/L. C line should appear in any cases, which indicates the reaction system is effective. Reference range Reference values:
Product Name Fecal Occult Blood(FOB)Test Kit (Colloidal Gold Method) Purpose To detect the content of FOB in human fecal in vitro qualitatively.For Professional Use only. Principles of Detection The FOB Rapid Test is a one-step chromatographic sandwich immunoassay. The test consists of: 1) a conjugate pad containing HB monoclonal antibody conjugated with colloidal gold. 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with another HB antibody, and the C line is pre-coated with a control line antibody (goat-anti-mouse IgG antibody). After addition of the sample, FOB will bind with a colloidal gold-labeled antibody on the conjugate release pad. The resulting complex flows over the nitrocellulose membrane where a specific capture reagent is pre-coated and a red line can be seen at the test zone (T). Unreacted colloidal gold-labeled antibodies in the sample are captured at the control zone (C). The intensity and speed at which the color develops depend on the FOB concentration in the sample. Reference range This kit can detect FOB at a minimum of 50ng/ml. Performance Characteristics 1. Critical value and repeatability: 1) The quality control substance of FOB with a concentration of 50ug/mL was detected for 20 times, and the positive coincidence rate was â?¥95%, and the color uniformity, and the reaction results were consistent. 2) The quality control substance of FOB with a concentration of 10ng/mL was detected for 20 times, and the negative coincidence rate was â?¥95%, and the color uniformity, and the reaction results were consistent. 2. Analysis specificity: 500ug/mL bovine HB,500ug/mL pork HB,500ug/ mL chicken HB,500ug/mL goat HB,2000ug/mL Horseradish Peroxidase specific quality control substance were all negative. 3.HOOK effect: human FOB positive quality control substance of 2000ug/mL was detected and the result was positive.
Product Name Glycosylated Hemoglobin(HbA1c)Test Kit (Immunofluorescence Chromatography) Purpose To detect the content of HbA1c in human whole blood in vitro quantitatively.For Professional Use only. Principles of Detection The HbA1c Test is a fluorescent lateral flow immunoassay. The test consists of: 1) a conjugate pad containing HbA1c 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 another HbA1c antibody, and the C line is pre-coated with a control line antibody (chicken IgY antibody). HbA1c 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 HbA1c according to the preset calibration curve in the machine and display the result, detection unit is %units. C line should appear in any cases, which indicates the reaction system is effective. Storage conditions and shelf life Store in a sealed aluminum foil bag at 2~30�°C. After unpacking the aluminum foil bag under temperature 20~30 �ºC , humidity 35~65%, please use it immediately. Shelf life 18 months. Applicable instrument Avid fluorescent immunoanalyzer model: AI-IF 600 Manufacturer& After-Sales Company: Shenzhen Aivd Biotechnology Co., LTD. Address:C501,Building B5,China Merchants Guangming Science Park, #3009 Guanguang Road, Guangming District, Shenzhen,Guangdong Province, China Tel: 0755-26165742 Fax:0755-26401805 Specimen collection and preparation 1. Human whole blood samples can be used for this test. 2. Specimen collection:Collect blood specimen into a collection tube containing EDTA , evenly mixed before use. Do not use hemolyzed blood for testing. Whole blood specimens should be stored at 2-8�°C for no more than 4 hours if not test immediately. 3. Do not test patients' samples with severe hemolysis, lipemia and jaundice, all specimens should be treated as infectant. 4. Restore the specimen to 20-30�°C before the detection, cryopreserved specimen should be completely thawed, rewarmed and evenly mixed before use. Reference range Positive: reading value â?¥6%, a positive result. Negative: reading value 8%, poorly controlled blood glucose. The reference value is verified with reference to similar products that have been marketed. Due to ethnic and geographical differences, each laboratory can establish its own reference interval according to the actual situation.
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