【Product Name】 Full Range C-reactive Protein (FR-CRP) Test Kit (Immunofluorescence) 【Package specifications】 25 Tests /Box 【Storage and stability】 Sealed: The kit must be stored at 4-30℃, valid for 24 months. The sample diluent must be stored at 4-30℃, valid for 24 months. Opened: The cartridge must be used within 1 hour once its foil pouch is opened. The sample diluent is valid for 1 month once it is opened. 【Procedure】 Preparation Installation of the immunofluorescence quantitative analyzer and reagent strip incubator Please read the operator’s manual of the immunofluorescence quantitative analyzer and reagent strip incubator carefully before use. Calibration Card installation Each box contains a lot-specific Calibration Card to correct for lot-to-lot deviation. Turn on the power switch, according to the system self-test prompt, waiting for the instrument to display the main interface. press “Assay Management”. Insert the Calibration Card into the card slot following the direction of the arrow, then press “Read". Confirm the lot number of the Calibration Card with the reagent relevant information, then press "Ok". Press “Return” to the main interface. Cartridge needs to reach room temperature before opened. Test procedure Remove the cartridge (after reaching room temperature), draw in 10μL of whole blood or plasma to FR-CRP sample diluent. After gently mixing the sample, add 90μL of diluted whole blood or plasma into the sample well and incubate it for 5 minutes in the reagent strip incubator. After incubation insert the cartridge into the immunofluorescence quantitative analyzer using the cartridge arrows as a guide, and click start, then the instrument will scan the cartridge automatically.

【Product Name】 Triiodothyronine (T3) Test Kit (Immunofluorescence) 【Package specifications】 25 Tests /Box 【Intended use】 Triiodothyronine (T3) Test Kit (Immunoflurescence) is mainly for the in vitro quantitative determination of Total triiodothyronine content in human serum.Triiodothyronine (T3) is a thyroid hormone that is directly synthesized and secreted by the thyroid and converted from peripheral Thyroxine (T4). Its secretion is regulated by a negative feedback mechanism involving thyroid-pituitary-hypothalamus. For healthy people, the concentration of Triiodothyronine (T3) in the blood is 1/50 of T4, and 99.7% of Triiodothyronine (T3) is combined with Thyroxine-Binding Globulin (TBG) and albumin Such as protein binding exists. Compared withTetraiodothyronine (T4), Triiodothyronine (T3) is quick-acting, and its physiological effect is also several times more than that of T4[1], [2].Thyroid dysfunction can  cause excessive or insufficient T3 secretion. In addition, because thyroid function is directly affected by Thyroid Stimulating Hormone (TSH), the dysfunction of the pituitary gland or hypothalamus will affect the secretion of Triiodothyronine (T3).concentration changes are more sensitive than T4 in certain thyroid diseases, and the blood T3 concentration is more conducive to the identification of hyperthyroidism. Under the conditions of strong thyroid stimulation, T3 levels can also be a good assessment of the body's thyroid hormone reserves [3]. However, when the changes of pregnant women, estrogen and androgens affect the level of TBG, the level of Triiodothyronine (T3) cannot reflect the actual status of the thyroid [4], [5] . At present, the commonly used detection methods in laboratories include enzyme-linked immunoassay, immunofluorescence, colloidal gold and chemiluminescence. 【Accessories required but not provided】 ♢ Immunofluorescence quantitative analyzer ♢ Reagent strip incubator 【Storage and stability】 Sealed: The kit must be stored at 4-30℃, valid for 24 months. The sample diluent must be stored at 4-30℃, valid for 24 months. Opened: The cartridge must be used within 1 hour once its foil pouch is opened. The sample diluent is valid for 1 month once it is opened.

【Product Name】 Thyroxine (T4) Test Kit (Immunofluorescence) 【Package specifications】 25 Tests /Box 【Intended use】 This Thyroxine (T4) Test Kit is manly used for in vitro quantitative determination of total thyroxine (TT4) content in human serum. Thyroxine (T4) is a hormone synthesized and secreted by the thyroid gland, which plays an important role in the regulation mechanism. Thyroxine (T4) is combined with thyroglobulin and stored in the remnant cavity of thyroid follicles, secreted and released under the regulation of thyroid stimulating hormone (TSH), and participates in the circulation [1] . More than 99% of thyroxine (T4) in the serum is in the form of binding to thyroxine-binding globulin (TBG), albumin and other proteins.The concentration of transport protein in the serum is easily affected by exogenous and endogenous effects. Ignoring changes in the concentration of bound protein (such as pregnancy, taking estrogen or suffering from nephrotic syndrome, etc.) will lead to errors in the detection of thyroid metabolism. Results [2], [3]. Diseases in any part of the thyroid-pituitary hypothalamic system can cause excessive (hyperthyroidism) or insufficient (hypothyroidism) secretion of T4 or T3, Therefore, the determination of total thyroxine (T4) can be used for the diagnosis of primary and secondary hypothyroidism and the monitoring of thyroid stimulating hormone (TSH) suppression therapy [4] . At present, the commonly used detection methods in laboratories include enzyme-linked immunoassay, immunofluorescence, colloidal gold and chemiluminescence. 【Accessories required but not provided】 ♢ Immunofluorescence quantitative analyzer ♢ Reagent strip incubator 【Storage and stability】 Sealed: The kit must be stored at 4-30℃, valid for 24 months. The sample diluent must be stored at 4-30℃, valid for 24 months. Opened: The cartridge must be used within 1 hour once its foil pouch is opened. The sample diluent is valid for 1 month once it is opened.

【Product Name】 Progesterone (PROG) Test Kit (Immunofluorescence) 【Package specifications】 25 Tests /Box 【Intended use】 It is mainly used for quantitative determination of progesterone (PROG) in human serum, plasma and whole blood in vitro. Progesterone content is the main index to monitor female ovulation and placental function. Progesterone (PROG) is an important steroid hormone with a molecular weight of 314.5 Dalton. It is mainly produced by ovarian corpus luteum and placenta during pregnancy. The main function of progesterone is to ensure the implantation of uterine fertilized eggs and maintain pregnancy. During the follicular phase of the physiological cycle, the level of progesterone remained very low, while after reaching the luteal phase, the content of progesterone increased rapidly. If ovulation is abnormal, progesterone will decrease abnormally in the middle of luteal phase, leading to infertility and abortion. The abnormal increase of progesterone may be related to adrenocortical hyperfunction. The commonly used detection methods in clinic and laboratory include chemiluminescence, immunofluorescence and so on. 【Accessories required but not provided】 ♢ Immunofluorescence quantitative analyzer ♢ Reagent strip incubator 【Storage and stability】 Sealed: The kit must be stored at 4-30℃, valid for 24 months. The sample diluent must be stored at 4-30℃, valid for 24 months. Opened: The cartridge must be used within 1 hour once its foil pouch is opened. The sample diluent is valid for 1 month once it is opened.

【Product Name】 Total Beta-Human Chorionic Gonadotropin (β-HCG) Test Kit (Immunofluorescence) 【Package specifications】 25 Tests /Box 【Intended use】 Total Beta-Human Chorionic Gonadotropin (β-HCG) Test Kit (Immunofluorescence) is mainly for the in vitro quantitative determination of β-HCG in human serum for the early detection of pregnancy. Human Chorionic Gonadotropin (HCG) is a glycoprotein hormone normally produced by placenta during pregnancy. Structurally intact hCG molecules consist of two non-covalently linked polypeptide subunits, the alpha and beta chain subunits. The α-subunit is common to luteinizing hormone (LH), follicle stimulating hormone (FSH) and thyroid stimulating hormone (TSH), while the β-subunit is unique to hCG. Amino acid residues specific for the β-subunit of hCG confer the immunochemical specificity. HCG is synthesized by trophoblastic tissue of the placenta in pregnancy, although it can be produced by other cells in various disease states. Serum concentrations of biologically active hCG (nonnicked hCG) rise exponentially in the first trimester of pregnancy, doubling every 48h, to a peak at about 10 weeks of gestation (weeks since last menstrual period). Concentrations decrease from the 10th to the 16th week of gestation, reaching approximately one-fifth of peak concentrations, and remain around this concentration until term. The hormone is present in pregnancy  serum and urine samples, along with a variety of dissociated or degraded hCG. With the availability of sensitive quantitative assays for the measurement of serum β-HCG, it has been shown that β-HCG levels can be useful in prediction of spontaneous abortions, aiding in the detection of ectopic pregnancy and multiple gestation. 【Accessories required but not provided】 ♢ Immunofluorescence quantitative analyzer ♢ Reagent strip incubator ♢ Pipette 【Storage and stability】 Sealed: The kit must be stored at 4-30℃, valid for 24 months. The sample diluent must be stored at 4-30℃, valid for 24 months. Opened: The cartridge must be used within 1 hour once its foil pouch is opened. The sample diluent is valid for 1 month once it is opened.

【Product Name】 Rheumatism Combo 3 in 1 (ASO/RF/CRP) Test Kit (Immunofluorescence) 【Package specifications】 25 Tests /Box 【Intended use】 Rheumatism Combo 3 in 1 (ASO/RF/CRP) Test Kit (Immunofluorescence) is mainly for the in vitro quantitative determination of ASO/RF/CRP content in human serum. Streptolysin O is one of several toxic extracellular enzymes produced by group A β - hemolytic streptococcus. The rise of anti streptolysin O titer is usually an indicator of a group β - hemolytic streptococcus infection recently, so it has become a routine indicator of diagnosis and treatment of acute rheumatic fever and acute glomerulonephritis. About 80-85% of people with recent streptococcal infection or its sequelae show an increased titer of antistreptolysin O. Rheumatoid factors are a heterogeneous group of autoantibodies directed against the antigenic determinants on the Fc‑region of IgG molecules. They are important in the diagnosis of rheumatoid arthritis, but can also be found in other inflammatory rheumatic diseases and in various non rheumatic diseases. They are also found in clinically healthy persons over 60 years of age. Despite these restrictions, the detection of rheumatoid factors is a diagnostic criterion of the American College of Rheumatology for classifying rheumatoid arthritis. The autoantibodies occur in all the immunoglobulin classes, although the usual analytical methods are limited to the detection of rheumatoid factors of the IgM type. C-reactive protein (CRP) is an acute phase reaction protein, which is very low in healthy people and increases sharply when the body is infected and tissue damage. C-reactive protein is a marker of inflammation and tissue damage, and its elevation is associated with the degree of infection and can be used to detect routine inflammation and cardiovascular inflammation, providing information on the diagnosis, treatment and monitoring of inflammatory diseases. 【Accessories required but not provided】 ♢ Immunofluorescence quantitative analyzer ♢ Reagent strip incubator ♢ Pipette 【Storage and stability】 Sealed: The kit must be stored at 4-30℃, valid for 24 months. The sample diluent must be stored at 4-30℃, valid for 24 months. Opened: The cartridge must be used within 1 hour once its foil pouch is opened. The sample diluent is valid for 1 month once it is opened.

【Product Name】 C-reactive Protein/Serum Amyloid A (CRP/SAA) Test Kit (Immunofluorescence) 【Package specifications】 25 Tests /Box 【Intended use】 C-reactive Protein/Serum Amyloid A (CRP/SAA) Test Kit (Immunofluorescence) is mainly for the in vitro quantitative determination of C-reactive Protein and Serum Amyloid A (CRP/SAA) content in human serum. C-reactive protein (CRP) is an acute phase reaction protein, which is very low in healthy people and increases sharply when the body is infected and tissue damage. C-reactive protein is a marker of inflammation and tissue damage, and its elevation is associated with the degree of infection and can be used to detect routine inflammation and cardiovascular inflammation, providing information on the diagnosis, treatment and monitoring of inflammatory diseases. The common detection methods in Clinic are Turbidity method, Immunofluorescence method, colloidal gold method and Chemiluminescence method. Serum amyloid A (SAA) began to rise after an inflammatory reaction of about 8h, with a significant increase in SAA at the time of viral infection, while CRP did not rise in virus infection without bacterial infection or may have increased slightly within a narrow enclosure. Combined detection of SAA and CRP can make up for the difference of CRP level in virus infection without significant, which is beneficial to the early diagnosis of infectious diseases in children. The detection methods commonly used in SAA Clinic are turbidity method, Immunofluorescence method, colloidal gold method and Chemiluminescence method. 【Accessories required but not provided】 ♢Immunofluorescence quantitative analyzer ♢Reagent strip incubator 【Storage and stability】 Sealed: The kit must be stored at 4-30℃, valid for 24 months. The sample diluent must be stored at 4-30℃, valid for 24 months. Opened: The cartridge must be used within 1 hour once its foil pouch is opened. The sample diluent is valid for 1 month once it is opened.

【Product Name】 Myocardial Infarction (MI) 3-in-1(cTnI/CK-MB/MYO) Test Kit (Immunofluorescence) 【Package specifications】 25 Tests /Box 【Intended use】 Myocardial Infarction (MI) 3-in-1 Test Kit (Immunofluorescence) is mainly for the in vitro quantitative determination of cardiac Troponin I (cTnI), Creatine Kinase-MB (CK-MB), Myoglobin (MYO) content in human serum. Cardiac Troponin I (cTnI) as one of the units of cardiac troponin (cTn), only exists in the atrial and ventricular myocytes, when myocardial cell membrane is complete, cTnI cannot penetrate the cell membrane into the blood circulation; when myocardial cells become necrosis due to ischemia or hypoxia, cTnI can enter the cytoplasm through damaged cell membrane, then enter the bloodstream, so cTnI can be used as an acute diagnostic index for acute myocardial infarction (AMI). As one of the three isoenzymes of creatine kinase (CK), CK-MB is mainly located in the myocardium, and has 20% activity of CK. CK-MB is an important index in the diagnosis of acute myocardial infarction (AMI), which is largely secreted into the blood when the AMI attacks, the concentration of CK-MB rises as early as 3 to 6 hours after onset, peaks at between 12 and 24 hours, and returns to normal after 3 days, if there are complications, serum CK-MB concentration will maintain at a high level, if AMI happens again, CK-MB will rise again. Myoglobin (MYO) is an oxygen-binding heme protein, mainly distributed in the cardiac and skeletal muscle. Myoglobin releases into the circulation as early as 2 to 3 hours after acute myocardial injury, peaks at between 9 and 12 hours, and returns to normal within 24 to 36 hours. It is recommended to sample and detect continuously for patients with acute coronary syndrome (ACS), because there is a delay between symptom appearing and blood releasing of protein makers. MYO negative is helpful to eliminate AMI, so myoglobin is one of the most important indexes for early diagnosis of AMI, and is widely used in the diagnosis of AMI, prognosis judgment and disease prediction. 【Accessories required but not provided】 ♢ Immunofluorescence quantitative analyzer ♢ Reagent strip incubator ♢ Pipette 【Storage and stability】 Sealed: The kit must be stored at 4-30℃, valid for 24 months. The sample diluent must be stored at 4-30℃, valid for 24 months. Opened: The cartridge must be used within 1 hour once its foil pouch is opened. The sample diluent is valid for 1 month once it is opened.