Pregnancy-testing kits

Bastian, L.A., K. Nanda, V. Hasselblad, and D. L. Simel. Diagnostic Efficiency of Home Pregnancy Test Kits A Meta-analysis. Archives of Eamily Medicine 7 no. 5 (1998) 465-469. 

There are several other HCG brands including veterinary. HCG always comes in two vials one contains a packed powder and the other contains sterile water. Once the product is mixed (swirled not shaken) it must be refrigerated. HCG was often what bogus Growth Hormone (GH) vials contained. A simple test for real GH was to buy a pregnancy test kit and drop a few drops into the test. If your test read pregnant, you are also screwed. This is because most test kits test for elevated gonadotropins and HCG will test as such, but GH will not. 

The term medical device is defined under section 2 of the Medicines Act 1981 and includes any device, instrument or apparatus (or its component parts) which is used principally in humans for a therapeutic purpose. It includes bandages and in vitro diagnostic agents. It should be noted that a number of products are defined as medicines in New Zealand which in other countries are controlled as medical devices (e.g., pregnancy test kits). 

In vivo diagnostic agents are medicines, while in vitro diagnostic products are mediccd devices (except pregnancy test kits, which are medicines). 

Hicks JM, losefsohn M. Reliability of home pregnancy-test kits in the hands of laypersons. N Engl J Med 1989 320 320-1. Erratum in N Engl J Med 1989 321 193. 

Medical devices can be anything from thermometers to artificial hearts to in-home pregnancy test kits. Devices, unlike drugs, are not dependent on a chemical action. Device inventors are more concerned with anatomy—skin, internal organs, tissue—and the compatibility of the device both within and on the surface of the body. 

Class II—Special Control Class-II devices, such as motorized wheelchairs, infusion pumps, surgical drapes, and some home pregnancy test kits, require additional regulation in order to ensure proper design and performance standards. Such devices may require special labeling and postmarket surveillance. Most medical devices fall into this category. 

J. M. Hicks and M. losefsohn. Reliability of Home Pregnancy-Test Kits in the Hands of Laypersons, New England Journal of Medicine, vol. 320, no. 5, pp. 320-321, 1989. 

Sometimes a man may act as a negative control when his partner uses a pregnancy test kit at liome. Teratoma of the testis has u peak incidence in men in their twenties. and this tumour frequently secretes large amounts of HCG. This will give rise to a positive pregnancy test in the man ... 

Hulisz DT, Urbanski CM. Home pregnancy testing kits. US Pharmacist 2002 21 22-32. 

The production of a small acidic protein, hCG or human chorionic gonadotropin during pregnancy is the basis of most pregnancy test kits. What method makes the most sense for detecting a known protein like this ... 

Most blood proteins do not show up in the urine, but hCG does. And it is produced very soon after the egg is fertilized, and then in increasing amounts as the pregnancy progresses. Sandwich ELISA (see Figure 4.35 in the text) is the ideal method for complex biological fluids, and it is relatively easy to produce two different monoclonal antibodies to epitopes on opposite sides of the protein. All home pregnancy test kits are based on variations of this method. 

A fnrther example is a simple dipstick assay, based on a test-paper-like platform with lateral-flow technology (Liu et al., 2006). This assay format is used mostly with antibody receptors (e.g., as in a well-known commercially available pregnancy test kit). The new aptamer dipstick was developed nsing the adenosine and cocaine aptamers described earlier (Huizenga and Szostak, 1995 Stojanovic et al., 2000). The cocaine test was also applied to human blood sernm samples (Lin et al., 2006). 

A priori, latices formed by the polymerization of dispersions of a water-insoluble monomer in aqueous media are expected to exhibit a wide distribution of particle sizes. In the 1950 s, chemists at the Dow Chemical Company discovered that a batch of polystyrene latex consisted of spherical particles that were uniform in diameter. At the time, this was considered a laboratory curiosity. Nowadays, monodisperse latices have found a wide variety of applications [74]. An early application was in pregnancy testing kits. Other uses are in diagnostic tests for various ailments and for the presence of illegal drugs. These microparticles are available in a variety of colors and with various functionalities along the polymer chains. They may be prepared as porous particles and as... 

In addition to incorporation in a BBIC format, the whole-cell bioreporter matrix can also be immobilized on something as simple as an indicator test strip. In this fashion, a home water quality indicator, for example, could be developed to operate in much the same way as a home pregnancy test kit. 

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