FastPack® IP

The FastPack System is a proprietary diagnostics platform launched by Qualigen in 2001. This novel, rapid and highly accurate immunoassay testing system consists of the FastPack Analyzer and the FastPack test pouch; a single-use, disposable, foil packet which includes the FastPack reagent chemistry. Since the initial conception of the system, the Company has developed two versions of its analyzer and test pouch (1.0 and IP) and has expanded its assay menu to 10, including tests for prostate cancer, thyroid function, metabolic disorders and research applications. 

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FastPack® IP Vitamin D Immunoassay

Vitamin D, known as the sunshine vitamin, is part of a group of fat‑soluble prohormones which encourage the metabolism of calcium and phosphorus in the body. Increasing research is now uncovering evidence illustrating the importance of vitamin D in the protection against a whole host of health issues. It is also estimated that as much as half the population in the world is deficient in vitamin D. The FastPack® IP Vitamin D immunoassay is intended for the quantitative determination of total 25‐hydroxyvitamin D and other hydroxylated metabolites in human serum and plasma. This assay is designed for use with the FastPack® IP System which is designed specifically for use in the practice laboratory setting.

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FastPack® IP Testo Immunoassay

Testosterone is a steroid hormone present in mammals that is primarily produced by the testes in males and the ovaries in females. The determination of testosterone levels in the body is crucial in the assessment of hypogonadal states, tumor detection and in monitoring hormone replacement. The FastPack® IP Testo Immunoassay is a chemiluminescent immunoassay for the in-vitro quantitative determination of total testosterone in human serum and plasma. The FastPack® IP Testo Immunoassay is designed for use with the FastPack® IP System.

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  FastPack® IP SHBG Immunoassay

Sex Hormone Binding Globulin (SHBG) is a glycoprotein that binds estrogens and androgens. The biologically active forms of these hormones are free, or unbound from SHBG. Therefore, accurately quantifying the SHBG level is critical in understanding overall hormone levels for patients undergoing hormone replacement.  The FastPack® IP SHBG Immunoassay is a chemiluminescent Immunoassay for the in-vitro quantitative determination of Sex Hormone Binding Globulin in human serum and plasma, and it is designed for use with the FastPack® IP System which is designed specifically for use in the practice laboratory setting.

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FastPack® IP Total PSA Immunoassay

The ability to test for Prostate Specific Antigen (PSA) has revolutionized the diagnosis and management of prostate disease. It is highly recognized that PSA testing plays a fundamental role in the early detection and monitoring of prostate disease, which many times will dictate the manner in which patients are treated. FastPack® IP Total PSA makes this test available to you at your fingertips. The FastPack® IP Total PSA immunoassay is a chemiluminescent immunoassay for the in-vitro quantitative determination of PSA in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack® IP Total PSA immunoassay is designed for use with the FastPack® IP System.

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  FastPack® IP Free PSA Immunoassay

FastPack® IP Free PSA immunoassay is a chemiluminescent immunoassay for the in-vitro quantitative determination of free prostate-specific antigen (free PSA) in human serum. FastPack® IP Free PSA immunoassay is designed for use in conjunction with the FastPack® IP System for calculating the ratio of free/total PSA, expressed as a percentage (percent free PSA).  The percent free PSA, as measured by the FastPack® IP System, is intended for use as an aid to differentiate between prostate cancer and benign prostatic conditions.

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FastPack® IP TSH Immunoassay

Realizing the importance of the thyroid hormones involved in regulating many of the systems found in the body, it becomes essential to have the ability to conveniently measure these values. The FastPack® IP TSH immunoassay is a chemiluminescent immunoassay for the in-vitro quantitative determination of thyroid stimulating hormone (TSH) in human serum and plasma. Measurements of TSH produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The FastPack® IP TSH immunoassay is designed for use with the FastPack® IP System and will provide these important quantitative test values.

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FastPack® IP Free T4 Immunoassay

In addition to thyroid stimulating hormone, Qualigen has made available the FastPack® IP Free T4 immunoassay. Determining Free T4 levels in the blood is essential in estimating the actual amount of T4 flowing in the blood and ultimately estimating the function of the thyroid gland. FastPack® IP Free T4 is a chemiluminescent immunoassay for the in-vitro quantitative determination of free thyroxin (fT4) in human serum. The FastPack® IP Free T4 immunoassay is designed for use with the FastPack® IP System.

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FastPack® IP hCG Immunoassay

The rapid rise in the production of Human Chorionic Gonadotropin (hCG) during the first trimester of a normal human pregnancy has made hCG a dependable indicator of the presence or absence of an implanted embryo. In addition to pregnancy testing, the ability to quantitate levels of hCG is useful in the evaluation of ectopic pregnancies and in monitoring germ cell and trophoblastic tumors. The FastPack® IP hCG Immunoassay is a chemiluminescence assay based on the “sandwich” principle which provides a quantitative value in measuring the level of hCG in human serum or plasma. The FastPack® IP hCG Immunoassay is designed for use with the FastPack® IP System.

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  FastPack® IP αGST Immunoassay

It is found that the detection of GST subclass levels in biological fluids would be of significant use in monitoring the integrity of specific hepatic regions in the liver. Since αGST has been found to be equally distributed in both the centrilobular and periportal regions of the liver, αGST would be a more sensitive indicator of hepatic status in a variety of clinical conditions including Allograft Rejection, Viral Hepatitis, Chronic Active Hepatitis and Hepatotoxicity. The FastPack® IP αGST Immunoassay is for the in-vitro quantitative determination of αGST in human serum and plasma. Measurement of αGST can be used as an aid in the assessment of liver damage. The FastPack® IP αGST Immunoassay is designed for use with the FastPack® IP System.

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