iFLASH SARS-CoV-2 IgM - India CDSCO Medical Device Registration

Product Information

The iFlash-SARS-CoV-2 IgM assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for qualitative determination of IgM antibody to SARS-CoV-2 in human serum or plasma using the iFlash Immunoassay Analyzer. The iFlash-SARS-CoV-2 IgM aids in the diagnosis of SARS-CoV-2 infection and the determination of immunity.,iFlash-Tg(YHLO)-The iFlash-Tg assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of thyroglobulin (YHLO) in human serum and plasma using the iFlash Immunoassay Analyzer. The iFlash-Tg assay is to be used as an aid in the detection of autoimmune thyroid diseases. Elevated Tg levels are present in a variety of thyroid disorders such as Graves’ disease, Hashimoto’s thyroiditis, and differentiated thyroid carcinoma (YHLO).,iFlash-Total PSA(YHLO)-The iFlash-Total PSA assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of total prostate specific antigen (YHLO) in human serum and plasma using the iFlash Immunoassay Analyzer. Elevated concentrations of PSA in serum are generally indicative of a pathologic condition of the prostate (YHLO). PSA testing has significant value in detecting metastatic or persistent prostate diseases in patients following surgical or medical treatment of prostate cancer. Persistent elevation of PSA following treatment, or an increase in a post-treatment PSA level is indicative of recurrent or residual disease. PSA testing is widely accepted as an adjunctive test in the management of prostate cancer patients. PSA tests lack sufficient sensitivity and specificity to be considered ideal or absolutely diagnostic for screening or early detection because PSA is not specific for prostate cancer. A number of studies have found that the % Free PSA (YHLO) was significantly lower in patients having prostate cancer than those with benign disease or normal controls. The ratio FPSA/TPSA has been demonstrated to improve the sensitivity and specificity in patients with TPSA values in the “gray zone” of 4-10 ng/mL.,iFlash-Free PSA(YHLO)-The iFlash-Free PSA assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for quantitative determination of free prostate specific antigen (YHLO) in human serum and plasma using the iFlash Immunoassay Analyzer. Elevated concentrations of PSA in serum are generally indicative of a pathologic condition of the prostate (YHLO). PSA tests lack sufficient sensitivity and specificity to be considered ideal or absolutely diagnostic for screening or early detection because PSA is not specific for prostate cancer. A number of studies have found that the % Free PSA (YHLO) was significantly lower in patients having prostate cancer than those with benign disease or normal controls. The ratio FPSA/TPSA has been demonstrated to improve the sensitivity and specificity in patients with TPSA values in the “gray zone” of 4-10 ng/mL.,iFlash-CA 19-9(YHLO)-The iFlash-CA 19-9 assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of Carbohydrate Antigen 19-9 (YHLO) in human serum and plasma using the iFlash Immunoassay Analyzer. CA 19-9 assay value is frequently elevated in the serum of subjects with various gastrointestinal malignancies, such as pancreatic, colorectal, gastric and hepatic carcinomas.,iFlash-CA 125(YHLO)-The iFlash-CA 125 assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of Cancer Antigen 125 (YHLO) in human serum and plasma using the iFlash Immunoassay Analyzer. Elevated values are sometimes found in various benign gynecological diseases such as ovarian cysts, ovarian metaplasia, endometriosis, uterus myomatosus and cervicitis. Markedly elevated levels have been found in benign liver diseases such as cirrhosis and hepatitis. Extreme elevations can occur in any kind of ascites due to malignant disease.,iFlash-CEA(YHLO)-The iFlash-CEA assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of carcinoembryonic antigen (YHLO) in human serum and plasma using the iFlash Immunoassay Analyzer. Carcinoembryonic antigen (YHLO) is an adhesion molecule (YHLO) for serum cells. Also, it is an immune glycoprotein associated with human tumor. Clinical relevance of the CEA assay has been shown in the management of patients with colorectal, gastric, breast, lung, prostatic, pancreatic, and ovarian carcinoma. Follow-up studies of patients with colorectal, breast, and lung carcinoma suggest that the preoperative CEA level has prognostic significance. CEA testing is not recommended as a screening procedure to detect cancer in the general population; however, use of the CEA test as an adjunctive test in predicting prognosis and as an aid in the management of cancer patients has been widely accepted.,iFlash-BNP(YHLO)-The iFlash-BNP assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of BNP in human serum and plasma using the iFlash Immunoassay Analyzer BNP as a quantitative marker of heart failure not only reflects left ventricular systolic dysfunction, also reflects left ventricular diastolic dysfunction, valvular dysfunction and dysfunction of the right ventricle,iFlash-PG II(YHLO)-The iFlash-PG II assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of Pepsinogen II in human serum and plasma using the iFlash Immunoassay Analyzer. Human pepsinogens have a diagnostic value for various gastroduodenal disorders, especially for peptic ulcer, atrophic gastritis and gastric cancer. The Pepsinogen I/ II ratio can provide even better information on the extent of chronic gastritis.,iFlash-PG I(YHLO)-The iFlash-PG I assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of Pepsinogen I in human serum and plasma using the iFlash Immunoassay Analyzer PG I level reliably correlates with the number of chief cells in the gastric corpus mucosa. Correspondingly, the loss of chief cells results in a linear decrease in PG I. The loss of chief cells is, on the other hand, a result of atrophic gastritis. So, PG I testing method is used for gastric mass screening in physical examination.,iFlash-Troponin-I(YHLO)-The iFlash-Troponin-I assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of Troponin-I in human serum and plasma using the iFlash Immunoassay Analyzer. For more than 15 years cTnI has been known as a reliable marker of cardiac muscle tissue injury. It is considered to be more sensitive and significantly more specific in diagnosis of the myocardial infarction.,iFlash-free beta hCG(YHLO)-The iFlash-free beta hCG assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of free βhCG in human serum using the iFlash Immunoassay Analyzer. Present studies have shown that free beta hCG can be used in the specificity assay of hCG and is significant to the assay of eccyesis and gestational trophoblastic disease. However, it cannot be used for auxiliary diagnosis of tumor. Nowadays, the major assay method of hCG is chemiluminescent immunoassay (YHLO) with the advantage of high sensitivity, wide-ranged detection, short reaction time and clinical fitting, which this reagent kit uses.,iFlash-CA 15-3(YHLO)-The iFlash-CA 15-3 assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of Cancer Antigen 15-3 (YHLO) in human serum and plasma using the iFlash Immunoassay Analyzer. Research studies have indicated that CA 15-3 assay values are frequently elevated in patients with breast cancer. Elevations of CA 15-3 assay values have been reported in individuals with nonmalignant conditions such as cirrhosis, hepatitis, autoimmune disorders, and benign diseases of the ovary and breast. The CA 15-3 assay may be of clinical value for monitoring the response of patients undergoing therapy because increasing and decreasing values correlated with disease progression and regression, respectively. Due to its high sensitivity for metastatic breast cancer, determination of CA 15-3 assay values is particularly important in the diagnosis of relapses and in monitoring relapse therapy.,iFlash-CYFRA21-1(YHLO)-The iFlash-CYFRA21-1 assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of Cytokerantin-19-fragment (YHLO) in human serum and plasma using the iFlash Immunoassay Analyzer. The main indication for CYFRA 21-1 is monitoring the course of non-small cell lung cancer (YHLO). Good specificity is shown by CYFRA 21-1 relative to benign lung diseases. Slightly elevated values (YHLO) are rarely found in marked benign liver diseases and renal failure. High CYFRA 21-1 serum levels indicate an advanced tumor stage and a poor prognosis. Successful therapy is documented by a rapid fall in the CYFRA 21-1 serum level into the normal range.,iFlash-AFP(YHLO)-The iFlash-AFP assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of Alpha1-fetoprotein (YHLO) in human serum and plasma using the iFlash Immunoassay Analyzer. More than 70% of patients with primary hepatocellular carcinoma have been reported to have elevated levels of serum AFP. Elevated AFP levels have occasionally been found in association with gastrointestinal tract cancers with and without liver metastases and only rarely in other tumors. Serum AFP has been found to be elevated during pregnancy, in diseases such as ataxia telangiectasia, hereditary tyrosinemia, teratocarcinoma and in benign hepatic conditions, such as acute viral hepatitis, chronic active hepatitis and cirrhosis. Elevation of serum AFP in benign hepatic diseases is usually transient.,iFLASH SARS-CoV-2 IgG(YHLO)-The iFlash-SARS-CoV-2 IgG assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for qualitative determination of IgG antibody to SARS-CoV-2 in human serum or plasma using the iFlash Immunoassay Analyzer. The iFlash-SARS-CoV-2 IgG aids in the diagnosis of SARS-CoV-2 infection and the determination of immunity.,iFlash-BNP(YHLO)-The iFlash-BNP assay is a paramagnetic particle chemiluminescent immunoassay (YHLO) for the quantitative determination of BNP in human and plasma using the iFlash Immunoassay Analyzer