Raj Biosis Private Limited

STANDARD F C. difficile GDH FIA qualitatively analyzes Clostridium difficile Glutamate Dehydrogenase (GDH) antigen in human stool specimen using Fluorescent Immunoassay (FIA). With a simple test method, the test result can be obtained within 15 minutes with its high sensitivity and specificity.

Vitamin B12, also called cobalamin, is a water-soluble vitamin. Cobalamin can be found in animal products such as meat, eggs, milk and other dairy products. During the intake process, cobalamin conjugates with a factor known as the combining binding-protein in the stomach, then absorbed by the ileum. Intrinsic factor is necessary for absorption process, once getting into the circulation; the cobalamin is stored in the liver. When being required, the cobalamin will be released into the plasma by the VB12 binding protein. VB12 is normally involved in the metabolism of every cell of the body, especially affecting the DNA synthesis and regulation but also fatty acid synthesis and energy production. However, many (though not all) of the effects of functions of VB12 can be replaced by sufficient quantities of folic acid (vitamin B9), since VB12 is used to regenerate folate in the body. Most VB12 deficiency symptoms are actually folate deficiency symptoms, since they include all the effects of pernicious anemia and megaloblastosis, which are due to poor synthesis of DNA when the body does not have a proper supply of folic acid for the production of thymine. The lack of VB12 can be caused by a variety of reasons. The most common reason is a lack of intrinsic factor, resulting in that VB12 cannot be absorbed from food. This condition is called anemia, mostly affecting people over the age of 50 years. The gastric resection is another reason of VB12 deficiency, after surgery or malabsorption caused by various bacteria or inflammatory disease affecting the small intestine. VB12 uptake has a positive correlation with the functional length of small intestine. The lack of VB12 is rarely caused by abnormal dietary, unless no animal food is consumed in years.

Use CMV IgG value as a kind of auxiliary material for other testing data when in diagnosis. Assay results should be utilized in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions. A skillful technique and strict adherence to the instructions are necessary to obtain reliable results. Bacterial contamination of samples or repeated freeze-thaw cycles may affect the test results. Assay results should be utilized in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions. 

STANDARD F Rota/Adeno Ag FIA is a fluorescent immunoassay for the qualitative detection of the presence of Rotavirus and/or Adenovirus antigens in fecal specimens. STANDARD F Rota/Adeno Ag FIA should be used with STANDARD F Analyzers manufactured by SD BIOSENSOR.

<p>STANDARD F Norovirus Ag FIA is a fluorescent immunoassay for the detection of Norovirus antigen in human fecal sample. The test kit is for in vitro use only.</p>

The TSH test is often the test of choice for evaluating thyroid function and/or symptoms of hyperthyroidism or hypothyroidism. It is frequently ordered along with or preceding a T4 test. Other thyroid tests that may be ordered include a T3 test and thyroid antibodies (if autoimmune-related thyroid disease is suspected). TSH testing is used to: Diagnose a thyroid disorder in a person with symptoms; Screen newborns for an underactive thyroid; Monitor thyroid replacement therapy in people with hypothyroidism Diagnose and monitor female infertility problems; Help evaluate the function of the pituitary gland (occasionally); Screen adults for thyroid disorders, although expert opinions vary on who can benefit from screening and at what age to begin; The doctor may order a TSH test when someone has symptoms of hyperthyroidism or hypothyroidism and/or when a person has an enlarged thyroid gland.

INTENDED USEThe kit has been designed for the quantitative determination of free β-chains of human chorionic gonadotropin (free β-HCG) in human serum. The method can be used for samples over the range of 1.1-200 ng/ml. The test has to be performed on the Fully-auto chemiluminescence immunoassay (CLIA) analyzer MAGLUMI (Including Maglumi 600,Maglumi 1000,Maglumi 1000 Plus, Maglumi 2000,Maglumi 2000 Plus,Maglumi 3000 and Maglumi 4000). 
SUMMARY AND EXPLANATION OF THE TEST Human chorionic gonadotropin (HCG) is a dimeic glycoprotein with a molecular weight of 37,000 Dalton consisting of an α and a β-subunit. The α–subunit of HCG is nearly identical with the analogous subunit of the pituitary hormones LH, FSH, and TSH. HCG is produced by the syncytiotrophoblast of the placenta and can be detected in maternal serum immediately upon nidation. HCG is responsible for maintain the function of the ovarian corpus luteum. In normal pregnancy, HCG concentrations rapidly increase with a doubling rate of approximately two days. Pathologically decreased values indicate abnormal pregnancy (e.g. ectopic pregnancy). A sudden fall of HCG levels before the 8th -10th week of gestation should be considered as a serious indicator of imminent abortion. If pregnancy can be excluded, HCG levels above normal are highly likely to indicate the presence of malignant neoplasms, particularly germ-cell tumors (e.g. testicular tumors, chorionic or ovarian carcinoma. For use as a tumor marker, the test system has to recognize both HCG and β-HCG, since testicular and chorionic carcinomas mainly secrete the free β-chains rather than the intact HCG molecule
PRINCIPLE OF THE TESTSandwich immunoluminometric assay: Use an anti-free-β-HCG monoclonal antibody to label ABEI, and use another monoclonal antibody to label FITC. Sample, Calibrators, or Control with ABEI Label, FITC Label and magnetic microbeads coated with anti-FITC are mixed thoroughly and incubated at 37℃, forming a sandwich; After sediment in a magnetic field, decant the supernatant, cycle washing for 1 time. Subsequently, the starter reagents are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as RLU within 3 seconds and is proportional to the concentration of free-β-HCG present in samples. 

Use an anti-PRL monoclonal antibody to label ABEI, and use another monoclonal antibody to Nano Magnetic Microbeads. Sample, Calibrator or Control with ABEI Label, and magnetic microbeads are mixed thoroughly and incubated at 37℃, forming a sandwich; after sediment in a magnetic field, decant the supernatant, then cycle washing for 1 time. Subsequently, the starter reagents are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as RLU within 3 seconds and is proportional to the concentration of PRL present in samples.

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Use an anti-FSH monoclonal antibody to label ABEI and use another monoclonal antibody to coat magnetic microbeads. Sample, Calibrator or Control with ABEI Label, and magnetic microbeads are mixed thoroughly and incubated at 37℃, forming a sandwich; After sediment in a magnetic field, suck the supernatant and then cycle wash it for 1 time. Subsequently, Starter 1+2 substrates are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as RLU within 3 seconds and is proportional to the concentration of FSH present in samples.

Use an anti-T3 monoclonal antibody to label ABEI, and use a purified T3 antigen to label Nano Magnetic Microbeads. Sample, Calibrator, or Control ,ABEI Label, and Buffer are mixed thoroughly and incubated at 37℃, Then add Nano Magnetic Microbeads and incubated, the Sample and Nano Magnetic Microbeads competitively binding the ABEI Label, forming a immuno-complex ,after sediment in a magnetic field, decant the supernatant, then cycle washing for 1 time. Subsequently, the starter reagents are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as RLU within 3 seconds and is proportional to the concentration of T3 present in samples.&nbsp;

PRINCIPLE OF THE TEST Competitive immunoluminometric assay: Use a purified 25-OH Vitamin D antigen to label ABEI, and use 25-OH Vitamin D monoclonal antibody to label FITC. Sample, Calibrator or Control with Displacing reagent, FITC Label and magnetic microbeads coated with anti-FITC are mixed thoroughly and incubated at 37℃, forming antibody-antigen complexes; After sediment in a magnetic field, decant the supernatant, then cycle washing for 1 time. Then add ABEI Label, incubation and washing for the 2nd time, sample antigen and ABEI labeled antigen compete to combine with FITC labeled monoclonal antibody, forming antibody-antigen complexes. Subsequently, the starter reagents are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as RLU within 3 seconds and is proportional to the concentration of 25-OH Vitamin D present in controls or samples.

Toxoplasmosis is a quite widespread infectious disease caused by an intracellular protozoan parasite, called Toxoplasma gondii. The disease, affecting both man and warm-blooded animals, can be transmitted by ingestion of food infected or contaminated by oocysts; direct contagion from domestic animals; or transplacental infection. Transmission of Toxoplasma through blood transfusions or organ transplantation has also been reported in the literature. In the normal adult population, toxoplasmosis has a generally benign course, being largely asymptomatic; sometimes mildly symptomatic (headache, sore throat, asthenia); or in rare cases accompanied by lymphadenitis. Exceptionally, severer disorders may be present, like myocarditis, hepatitis, pneumonia, meningoencephalitis and retinochoroiditis. The prevalence of positive serological tests increases with age, indicating past exposure. Cell-mediated immunity is generally involved in protecting from parasite infection. As a consequence, a symptomatic course is generally more frequent in patients undergoing immune -suppressive therapy, either to prevent organ rejection or as an anti-tumor therapy. Toxoplasmic encephalitis has proved to be a significant cause of death in patients with acquired immuno -deficiency syndrome.

Use an anti-LH monoclonal antibody to label ABEI, and use another monoclonal antibody to coat magnetic microbeads. Sample, Calibrator or Control, with ABEI Label and magnetic microbeads are mixed thoroughly and incubated at 37℃, forming a sandwich; After sediment in a magnetic field, suck the supernatant and then cycle wash it for 1 time.Subsequently, the starter reagents are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as RLU within 3 seconds and is proportional to the concentration of LH present in samples.

Use an anti-T4 monoclonal antibody to label ABEI, and use a purified T4 antigen to coat Nano Magnetic Microbeads. Sample, Calibrator, or Control ,Buffer, mixed thoroughly with ABEI Label, and Nano Magnetic Microbeads and incubated at 37℃, then the Sample and Nano Magnetic Microbeads competitively binding the ABEI Label, forming a immuno-complex, after sediment in a magnetic field, decant the supernatant, then cycle washing for 1 time. Subsequently, the starter reagents are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as RLU within 3 seconds and is proportional to the concentration of FT4 present in samples. 

Total T4 and free T4 are two separate tests that can help a doctor evaluate thyroid function. The total T4 test has been used for many years to help diagnose hyperthyroidism and hypothyroidism. It is a useful test but can be affected by the amount of protein available in the blood to bind to the hormone. The free T4 test is a newer test that is not affected by protein levels. Since free T4 is the active form of thyroxine, the free T4 test is thought by many to be a more accurate reflection of thyroid hormone function and, in most cases, its use has replaced that of the total T4 test. Whichever thyroxine measurement is ordered, it is usually ordered along with or following a TSH test. This helps the doctor to determine whether the thyroid hormone feedback system is functioning as it should, and the results of the tests help to distinguish between different causes of hyperthyroidism and hypothyroidism. Sometimes a T3 test will also be ordered to give the doctor additional diagnostic information. A T4 and TSH test may be ordered to help evaluate a person with a goiter and to aid in the diagnosis of female infertility. If a doctor suspects that someone may have an autoimmune-related thyroid condition, then thyroid antibodies may be ordered along with a T4 test. In those with known thyroid dysfunction, T4 and/or TSH tests may be ordered to monitor thyroid function. Newborns are commonly screened for T4 levels as well as TSH concentrations to check for congenital hypothyroidism, which can cause mental retardation if left untreated. A total T4 or free T4 test is primarily ordered in response to an abnormal TSH test result. Sometimes the T4 will be ordered along with a TSH to give the doctor a more complete evaluation of the adequacy of the thyroid hormone feedback system. These tests are usually ordered when a person has symptoms of hyperthyroidism or hypothyroidism. Signs and symptoms of hyperthyroidism may include: Increased heart rate; Anxiety; Weight loss; Difficulty sleeping; Tremors in the hands; Weakness; Diarrhea (sometimes); Light sensitivity, visual disturbances. The eyes may be affected: puffiness around the eyes, dryness, irritation, and, in some cases, bulging of the eyes. Symptoms of hypothyroidism may include: Weight gain, Dry skin, Constipation, Cold intolerance, Puffy skin, Hair loss, Fatigue, Menstrual irregularity in women. Severe untreated hypothyroidism, called myxedema, can lead to heart failure, seizures, and coma. In children, hypothyroidism can stunt growth and delay sexual development. Sometimes they are ordered as screening tests during routine blood testing, but expert opinions vary on who can benefit from screening and at what age to begin. In those with known thyroid disorders, the TSH and sometimes T4 are ordered at intervals to monitor the effectiveness of treatment. In pregnant women with thyroid disorders, the doctor is likely to order thyroid testing early and late in the pregnancy and for a time period following delivery to monitor the mother and baby. Thyroid hormone screening is commonly performed on newborns as part of newborn screening programs

Mouse anti-human IgG is used to label ABEI, and use purified Rubella antigen to coat nano magnetic microbeads. Sample, Calibrator or Control with Buffer（goat Anti-human IgM, goat Anti-human IgA） and nano magnetic microbeads coated with Rubella antigen are mixed thoroughly and incubated at 37℃ and cycle washing for 1 time. Then add ABEI Label, incubation and form a sandwich, then washing for the 2nd time. Subsequently, the starter reagents are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as RLU within 3 seconds and is proportional to the concentration of Rubella IgG present in samples

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This is a screening test that quantifies microalbumin from the first urine in the morning or random concentrated urine to check the extent of kidney damage and predict the progression to kidney failure. Continuous measurement of microalbumin concentration can help patients receive appropriate treatment and confirm treatment effects.

STANDARD F Legionella Ag FIA test system (Analyzer + Test device) detects Legionella pneumophila serogroup 1, 3, 5, 6 and 8 antigens via urine sample. Without any further sample processing, STANDARD F Legionella Ag FIA performs highly sensitively, and the test is not affected by Rheumatoid factor.Advantage Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance Objective result - Eliminates the subjectivity of a visual result Automatic strip recognition by reading the information stored in 2D barcodeTime saving by early detection - in case of high titer samples, the analyzer automatically show the test results in 5 minutes.

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.

 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. 

STANDARD F TB-Feron FIA (IFN-gamma) aids to diagnosis of Tuberculosis infection. TB Antigens coated in TB-Feron Tube stimulate T cells in heparinized whole blood from patients with symptoms of Tuberculosis (TB), and T cells secrete interferon-γ (IFN-γ). The concentration of IFN-γ is measured by fluorescent immunoassay (FIA) to identify in vitro responses to those recombinant TB Antigens that are associated with M.tuberculosis infection.Advantage Test result can be provided in 15 minutes with STANDARD F analyzer Kit can be stored at room temperature 

Lyme disease is caused by bacteria, Borrelia burgdorferi that are transmitted through black-legged or deer tick. STANDARD F Lyme IgM/IgG FIA is a fluorescent immunoassay for the detection of B. burgdorferi specific IgM and IgG antibodies in human whole blood, serum, and plasma samples.Advantage  Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance Objective result - Eliminates the subjectivity of a visual result Automatic strip recognition by reading the information stored in 2D barcode Reagents can be stored at room temperature

STANDARD F U-Albumin FIA is a test for the quantitative measurement of microalbumin in human urine. This test is to aid to the prediction of diabetic nephropathy and cardiovascular diseases (CVD).
Advantage Able to perform accurate quantitative analysis using fluorescent substance Reagents can be stored at room temperature Automatic strip recognition by reading the information stored in 2D barcode

Standard F NT- Pro BNP FIA is a quantitative test for the determination of the N-terminal pro brain-type natriuretic peptide (NT-proBNP) level in human serum and whole blood(EDTA). Advantage Early diagnosis of acute heart failure Risk stratification of heart failure Useful tool to guide referral of chronic heart failure Significant cost savings due to shorter stays in the ED.

STANDARD F Zika IgM FIA qualitatively analyzes Zika virus specific IgM antibodies in serum, plasma and whole blood using fluorescent immunoassay. Screening test results can be obtained within 15 minutes with high sensitivity and specificity. Advantage Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance Objective result - Eliminates the subjectivity of a visual result Automatic strip recognition by reading the information stored in 2D barcod

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.

STANDARD F LH FIA is a fluorescent immunoassay for the quantitative measurement of LH level in human serum, plasma and whole blood. This test is performed to help evaluate fertility issues, function of reproductive organs (ovaries or testicles), or to detect the ovulation.Advantage Automatic strip recognition by reading the information stored in 2D barcode Reagents can be stored at room temperature Whole blood, serum and plasma specimens available

STANDARD F Strep A Ag FIA performs qualitative analysis by detecting Group A streptococcal antigens in samples using fluorescence immunochromatography. This product&amp;rsquo;s performance is much higher than that of other products that use the existing Gold conjugate; through STANDARD F Analyzer, test results with high sensitivity and specificity can be obtained.&lt;br /&gt;&lt;br /&gt;Advantage &lt;ul&gt; &lt;li&gt;Able to perform accurate quantitative analysis using fluorescent substance&lt;/li&gt; &lt;li&gt;Objective result - Eliminates the subjectivity of a visual result&lt;/li&gt; &lt;li&gt;Automatic strip recognition by reading the information stored in 2D barcode&lt;/li&gt; &lt;/ul&gt;

This product performs qualitative analysis on NS1 antigen of Dengue virus in serum, plasma and whole blood. Advantage Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance Objective result - Eliminates the subjectivity of a visual result Automatic strip recognition by reading the information stored in 2D barcode  Time saving by early detection

Human Chorionic Gonadotropin (&beta;-hCG) Distinguish pregnancy and abnormal pregnancy. The &beta;-hCG test can be used to confirm pregnancy, the age of the fetus, abnormal pregnancy (ectopic pregnancy), potential miscarriage, and down syndrome.

STANDARD F TSH-II FIA is a quantitative test for the determination of the thyroid stimulating hormone (TSH) level in human serum and whole blood(EDTA). Advantage Diagnosis of thyroid disorders Monitoring treatment of hypothyroidism and hyperthyroidism 

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.

STANDARD F Adeno Respi FIA test (Analyzer+Test device) is a rapid diagnostic test that can use commercially. It has high accuracy, and provides the test result in 15 minutes with the STANDARD F analyzer.&lt;br /&gt;&lt;br /&gt;Advantage &lt;ul&gt; &lt;li&gt;Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance&lt;/li&gt; &lt;li&gt;Objective result - Eliminates the subjectivity of a visual result&lt;/li&gt; &lt;li&gt;Automatic strip recognition by reading the information stored in 2D barcode&lt;/li&gt; &lt;li&gt;Reagents can be stored at room temperature&lt;/li&gt; &lt;/ul&gt;

Scrub typhus is a disease caused by Orientia tsutsugamushi that is spread through chiggers (larval mites). STANDARD F Tsutsugamushi IgM/IgG FIA is a fluorescent immunoassay for the detection of O. tsutsugamushi bacteria specific IgM and IgG antibodies in human whole blood, serum, and plasma samples.Advantage Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance Automatic strip recognition by reading the information stored in 2D barcode Objective result - Eliminates the subjectivity of a visual result Reagents can be stored at room temperature

Oscar reagent kit-Sodium reagent kit Phosphorus Reagent kit glucose reagent kit Uric acid Reagent kit Urea ( End point Reagent kit) Urea-kinetic reagent kit Total protein Reagent kit potassium reagent kit hdl triglyceride Reagent kit

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).

STANDARD F Vitamin D FIA is an in vitro diagnostic for the quantitative measurement of total 25-hydroxy Vitamin D (25-OH Vitamin D) in human serum and plasma.

Evaluating ovarian function & predicting controlled ovarian hyperstimulation AMH levels help predict the remaining egg reserve. This can tell a lot about the reproductive issues, including the onset of menopause, amenorrhea, polycystic ovary syndrome. This test also tells the expected response to controlled ovarian hyperstimulation to achieve pregnancy in IVF.