Ichroma Anti-Ccp Test

Intended use: Toxoplasma IGG/IGM rapid test is a rapid immunochromatographic test for the simultaneous detection of IGM and IGG antibodies to toxoplasma gondii in human serum/plasma. The test can be used as a screening test for toxoplasma infection and as an aid for differential diagnosis of the self limiting primary toxoplasma infections and the potentially fatal secondary toxoplasma infections in conjunction with other criteria. Test principle: The toxoplasma IGG/IGM rapid test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) A burgundy colored conjugate pad containing toxoplasma recombinant envelope antigens conjugated with colloid gold (toxoplasma 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-toxoplasma, t2 band is coated with antibody for the detection of igg anti-toxoplasma, and the c band is pre-coated with goat anti rabbit IGG. 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. Reagents and materials supplied : 1. Test cassette individually foil pouched with a desiccant. 2. Plastic dropper 3. Buffer 4. Package insert. Storage and stability: The kit must be stored at 2-30pc. Warning and precautions: 1. For in vitro diagnostic use only. Not for medicinal use. 2. Do not use beyond expiry date. 3. Read the instructions careful y before performing the test. 4. Handle all specimen as potential y infectious. 5. Follow standard biosafety guidelines for handling and disposal of potential y infective material.

Anti-SARS-CoV-2 Rapid Test, COVID-19 1. Easier: No special equipment needed, Intuitive visual interpretation. 2. Rapid: Quick sampling by fingertip blood, Results in 10-15min. 3. Accurate: Results with IgG and IgM respectively. 4. Application: as screening tool for potential suspect patients in large numbers. Testing kit is FDA Emergency Use Authorization (EUA) Approved Testing kit is CE MARKED-IVD * Instruction for Use * Interpretation Guide * SARS-CoV-2 immunoassays * Accuracy of the Anti-SARS-CoV-2 Rapid Test Kit * Anti-SARS Rapid Test Brochure * COVID-19 Catalog * EUA Approval Letter * Fact Sheet for Healthcare Providers * FDA Letter * Fact Sheet for Recipients * FAQ * CE IVD Notification Certificate Antibody Performance Measure Estimate of Performance 95% Confidence Interval IgM Sensitivity (PPA) 95.7% (289/302) (92.8%; 97.5%) IgM Specificity (NPA) 99.7% (311/312) (98.2%; 99.9%) IgG Sensitivity (PPA) 99.0% (299/302) (97.1%; 99.7%) IgG Specificity (NPA) 99.4% (310/312) (97.7%; 99.8%) Combined Sensitivity (PPA) 99.0% (299/302) (97.1%; 99.7%) Combined Specificity (NPA) 99% (309/312) (97.2%; 99.7%) Combined PPV at prevalence = 5% 84.4% (64.6%; 94.6%) Combined NPV at prevalence = 5% 99.9% (99.8%; 100%) Testing kit is FDA Emergency Use Authorization (EUA) Approved Testing kit is CE MARKED-IVD * Instruction for Use * Interpretation Guide * SARS-CoV-2 immunoassays * Accuracy of the Anti-SARS-CoV-2 Rapid Test Kit * Anti-SARS Rapid Test Brochure * COVID-19 Catalog * EUA Approval Letter * Fact Sheet for Healthcare Providers * FDA Letter * Fact Sheet for Recipients * FAQ * CE IVD Notification Certificate

Product Details: Brand : Boditech Med Incorporated Size : 25 T Samples : Human serum/plasma/ control Specimen volume : 75 Microliter stored at ; 4 - 30 DegreeC Cat No ; CFPC-44 T3 Assessing to diagnosis & to monitor thyroid diseases(T3) This test assesses the level of T3 in the blood to diagnose thyroid dysfunction, help to receive appropriate treatment, and help to confirm the treatment effect through periodic measurement. INTENDED USE : ichroma T3 is a fluorescence Immunoassay (FIA) for the quantitative determination of triiodothyronine (total T3) in human serum/plasma. It is useful as an aid in management and monitoring of determination of thyroid disorders. For in vitro diagnostic use only. PRINCIPLE : The test uses a competitive immunodetection method. In this method, the analyte in the sample binds to the fluorescence labeled (FL) detection antibody in detection buffer, to form the complex as sample mixture. This complex is loaded to migrate onto the nitrocellulose matrix, where the covalent couple of T3 and bovine serum albumin (BSA) is immobilized and interferes with the binding of analyte and fluorescence labeled (FL) antibody. If more analytes exist in the sample, less detection antibodies are accumulated, resulting in less fluorescence signal. MATERIALS SUPPLIED : REF CFPC-44 Components of ichroma T3 Cartridge Box: - Cartridge 25 - Detector tube 25 - Detector diluent 2 - ID chip 1 - Instruction for Use 1

Product Details: Brand : Boditech Med Incorporated Size : 25 T Specimen : Human serum/plasma/ control Specimen volume : 75 microliter stored at 4 - 30 DegreeC. Cat No : CFPC-26 T4 Assessing to diagnosis & to monitor thyroid diseases(T4) Thyroxine (T4) is a type of thyroid hormone. An abnormal amount of T4 may indicate thyroid disease. The T4 test measures total T4, including T4 bonded to protein and free T4. A T4 test will help determine what type of problem is affecting the thyroid. INTENDED USE : ichroma T4 is a fluorescence Immunoassay (FIA) for the quantitative determination of thyroxine (T4) in human serum/plasma. It is useful as an aid in management and monitoring of thyroid disorder. For in vitro diagnostic use only. PRINCIPLE : The test uses a competitive immunodetection method. In this method, the target material in the sample binds to the fluorescence (FL)-labeled detection antibody in detector, to form the complex as sample mixture. This complex is loaded to migrate onto the nitrocellulose matrix, where the covalent couple of T4 and bovine serum albumin (BSA) is immobilized on a test strip, and interferes with the binding of target material and FL-labeled antibody. If the more target material exists in blood, the less detection antibody is accumulated, resulting in the less fluorescence signal. MATERIALS SUPPLIED : REF CFPC-26 Components of ichroma T4 Cartridge Box: - Cartridges 25 - ID Chip 1 - Insert 1 - Detector tube (Granule) 25 - Detector diluent (5.5 mL) 1

Product Details: Brand ; Boditech Med Incorporated Size : 25 T Samples: human whole blood/serum /plasma Specimen volume human whole blood/serum/ plasma stored at 4-30 C Cat. No. : CFPC-66 Human Chorionic Gonadotropin (�²-hCG) Distinguish pregnancy and abnormal pregnancy The IhCG test can be used to confirm pregnancy, the age of the fetus, abnormal pregnancy (ectopic pregnancy), potential miscarriage, and down syndrome. INTENDED USE : ichroma -HCG Plus is a fluorescence Immunoassay (FIA) for the quantitative determination of -HCG in human whole blood/serum /plasma. It is useful as an aid in management and monitoring of beta human chorionic gonadotropin (hCG) level in human For in vitro diagnostic use only. PRINCIPLE : The test uses a sandwich immunodetection method; Dried antibodies in the detector tube, once diluted with the diluent, bind with antigens in the sample to form antigen-antibody complexes. These complexes then migrate through the nitrocellulose matrix and are captured by another sets of immobilized antibodies on the test line. The more antigens in the sample, the more antigen-antibody complexes, which leads to a stronger fluorescence signal. This signal then is interpreted by the reader to display the �²-HCG concentration in the sample. STORAGE AND STABILITY : The cartridge is stable for 20 months (while sealed in the original aluminum foil pouch) if stored at 4-30 C. The detector, diluent and sample diluent are stable for 20 months if stored at 2-8 C. After the cartridge pouch is opened, the test should be performed immediately. MATERIALS SUPPLIED : REF CFPC-66 Components of ichroma-HCG Plus Cartridge Box: - Cartridges 25 - ID Chip 1 - Instruction For Use 1 Buffer Box For ichorma II - Detectors (Capped with plastic lid) 25 - Diluent 1 For AFIAS-50 - Detectors (Sealed with aluminum foil) 25 - Diluent 1 Sample Diluent Box: - Sample Diluent Tubes 25

Product Details: Brand: Boditech Med Incorporated Size : 25 T Samples : human serum/plasma Specimen volume : 150 Microliter stored at 4 - 30 DegreeC. Cat. No : CFPC-22 Thyroid Stimulating Hormone (TSH) Diagnosing thyroid dysfunction One needs an adequate level of thyroid hormone. The excessive or insufficient level would cause various abnormalities in human physiology. The TSH test can deliver the required answer about the hormone level in 12 minutes with fingertip blood (US FDA 510k; AFIAS TSH). INTENDED USE : ichroma NT-proBNP is a fluorescence Immunoassay (FIA) for the quantitative determination of NT-proBNP in human whole blood/serum/plasma. It is useful as an aid in the diagnosis of persons suspected of having congestive heart failure. For in vitro diagnostic use only. PRINCIPLE : The test uses a sandwich immunodetection method; the detector antibodies in buffer bind to antigens in the sample, forming antigen-antibody complexes, and migrate onto the nitrocellulose matrix to be captured by the other immobilized-antibodies on test strip. More antigens in the sample will form more antigen-antibody complexes which lead to stronger fluorescence signal by detector antibodies, which is processed by instrument for ichromaâ?¢ tests to show NT-proBNP concentration in the sample. MATERIALS SUPPLIED : REF CFPC-77 Components of ichroma NT-proBNP Cartridge Box: - Cartridge 25 - ID Chip 1 - Instruction for Use 1 Buffer Box For ichroma II - Detector tube 25 - Detector diluent 1 For ichroma-50 - Detector tube 25 - Detector diluent 1

Product Details: Brand : Boditech Med Incorporated Size : 25 Test Samples : Whole blood Sample volume : 75 Microliter Cat No : CFPC-38 Storage Temperature ; 4 - 30 DegreeC HbA1c Assessing the level of glycated hemoglobin in the blood This test is certified by NGSP (National Glycohemoglobin Standardization Program). It helps diabetic diagnosis, treatment, and prognosis by measuring the glycated hemoglobin concentration (%) in a small amount of blood over the past 3 months. INTENDED USE ichroma HbA1c is a fluorescence Immunoassay (FIA) for the quantitative determination of HbA1c(Hemoglobin A1c) in human whole blood. It is useful as an aid in management and monitoring of the longterm glycemic status in patients with diabetes mellitus. For in vitro diagnostic use only. PRINCIPLE: The test uses a sandwich immunodetection method; the detector antibody in buffer binds to antigen in sample, forming antigen-antibody complexes, and migrates onto nitrocellulose matrix to be captured by the other immobilized-antibody on test strip. The more antigen in sample forms the more antigen-antibody complex and leads to stronger intensity of fluorescence signal on detector antibody. Instrument for ichromaâ?¢ tests displays the content of glycated hemoglobin in terms of percent of the total hemoglobin in blood.

Product Details: Brand : Boditech Med Incorporated Size : 25 T Samples : whole blood/serum/plasma Sample volume : 75 Microliter stored at 4 - 30 DegreeC Cat No i CHROMA PSA-25 Prostate Specific Antigen (PSA) Screening for the prostate cancer & monitoring the effects of the treatment This test helps in the early detection of prostate diseases such as enlarged prostate and prostatitis and prostate cancer by quantifying PSA in male blood, as well as observation of treatment effects and monitoring of recurrence.

Product Details: Brand ; Boditech Med Incorporated Size : 25 Test Samples : Serum/Plasma Recommended anticoagulant K2 EDTA, K3 EDTA, sodium heparin Storage Temperature : 4 - 30 DegreeC Cat No : CFPC-21 Progesterone Monitoring ovulation abnormalities and predicting miscarriage & ectopic pregnancy The progesterone test kit measures the level of progesterone in the blood. The progesterone test alone is not enough to diagnose a particular problem. But the result may help provide answers to causes of infertility, risk of miscarriage, ovulation, and ectopic pregnancy. PRINCIPLE : The test uses a competitive immunodetection method. In this method, the analyte in the sample binds to the fluorescence labeled (FL) detection antibody in detection buffer, to form the complex as sample mixture. This complex is loaded to migrate onto the nitrocellulose matrix, where the covalent couple of progesterone and bovine serum albumin (BSA) is immobilized, and interferes with the binding of analyte and fluorescence labeled (FL) antibody. If more analytes exist in the sample, less detection antibodies are accumulated, resulting in less fluorescence signal.