Russian term (edited): ���������

Just an idea.

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Note added at 6 mins (2004-07-01 15:51:17 GMT)
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Although... There is more than 700 cases in Google:

... Applicability of a set of diagnostic tests in indoor air health research International
Journal of Hygiene and Environmental Health February 2004, vol. 207, no. ...
www.ingenta.com/.../ExpandTOC/ingenta?issue=pubinfobike:/ /urban/441/2004/00000207/00000002&index=4

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Note added at 6 mins (2004-07-01 15:51:29 GMT)
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... 1-TuffTEST-Lite is comprised of the most thorough and rigorous set of diagnostic
tests and functions for Main Memory, the first 8 MB of Extended Memory (#1 ...
www.tufftest.com/tt01-lite.htm

Russian term (edited): ���������

There are two case in this question. The 1-st is about "combination-tests" for detecting HIV-1 and HIV-2(but they are only for serum). The 2-nd is combination collection and testing device.
*To address this issue, commercially available HIV-1/2 "combination tests," which incorporate antigens from both viruses, can be used to screen sera in an attempt to identify either infection. The subsequent differentiation of HIV-1 and HIV-2 infections necessitates the use of highly specific ELISA (e.g., synthetic peptide-based), Western blot, radio-immunoprecipitation assays, or the polymerase chain reaction.*
* This test, the OraQuick (OraSure Technologies/Epitope), is a combination collection and testing device. Consisting of an absorbent (porous) pad on a stick coupled to a lateral flow testing device, it is used to swab once around the gums, and placed in a vial of buffer solution. Following a 20 minute incubation, the results are read like other lateral flow rapid tests (a control line is included also). The manufacturer claims a 100% sensitivity and a specificity that is equivalent to ELISA HIV tests. This device can also be used for testing serum, whole venipuncture blood, or blood collected via fingerstick, thereby giving flexibility for different testing situations.*
http://hivinsite.ucsf.edu/InSite?page=kb-02-02-01Types of HIV Tests: Oral Fluid Test
On December 23, 1994, the FDA approved the first HIV oral test system in the United States, intended for use in subjects 13 years of age or older. This test is not as accurate as the approved HIV-antibody tests used on blood. Studies show that for every 100 persons infected with HIV, the oral-fluid-based test will miss one or two, and for every 100 persons who are not infected, test results will be incorrectly positive in approximately two. The test system includes a specially treated cotton pad on a stick and a preservative solution in a plastic container. A trained collector instructs the subject to place the pad between the lower gum and cheek to obtain a sample of oral fluid. The pad is then stored in the preservative until the sample is processed and analyzed by a qualified laboratory using an enzyme-linked immunosorbent assay (ELISA) specifically licensed for testing oral fluid samples. FDA approved this HIV test system with the following restrictions:
• The test system is available for purchase and distribution only through physicians.
• The test system may be administered only by individuals properly trained in its use.
• The test must not be provided to subjects for home use.
• Testing of the oral fluid samples for HIV antibodies may be carried out only with the Oral Fluid Vironostika HIV-1 Microelisa® System, manufactured by Organon Teknika Corporation of Durham, NC.
• The test may be used for diagnosis only and must not be used to screen blood donors.
• Before the oral fluid specimen is collected, subjects must be given information on HIV prevention and transmission, as well as technical information regarding the oral test. Because there are no confirmatory tests that use oral fluid samples, subjects must be informed that in the event of a positive oral fluid sample, they should have blood samples drawn and tested to verify their HIV status. http://www.vnh.org/PreventionPractice/ch40.htmlhttp://www.vn...

So, the question is about the 2-nd case and there are tha combination the collection and testing device. But I didn't see anything about HIV 1,2.



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Note added at 7 hrs 15 mins (2004-07-01 23:00:50 GMT)
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http://www.fda.gov/cber/products/testkits.htm
Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
Abbott HIVAB HIV-1/HIV-2 (rDNA) EIA EIA Serum / Plasma Donor Screen Abbott Laboratories
Abbott Park, IL
US License 0043 2/14/1992
Genetic Systems HIV-1/HIV-2 Peptide EIA EIA Serum / Plasma / Cadaveric Serum Donor Screen Bio-Rad Laboratories Blood Virus Division
Redmond, WA
US License 1109 12/9/2000
Genetic Systems HIV-1/HIV-2 Plus O EIA EIA Serum / Plasma Donor Screen Bio-Rad Laboratories Inc
Hercules, CA
US License 1109 8/5/2003 -
Это все, что утверждено ФДА по поводу обоих типов вируса( данные по 2003 год)- слюны нет.
Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay)
Oral Fluid Vironostika HIV-1 Microelisa System EIA Oral Fluid Non-Donor Screen bioMerieux, Inc
Durham, NC 27712
12/23/1994
Product: OraSure HIV-1 Western Blot Kit
Applicant: Epitope, Inc., Beaverton, OR
PMA number: BP950004
Indication for use: In-vitro qualitative assay for the detection of antibodies to HIV-1 in human oral fluid specimens obtained with the Orasure HIV-1 Oral Specimen Collection Device; and as an additional, more specific test for HIV-1 antibodies in OraSure specimens collected from individuals found to be repeatedly reactive by the Oral Fluid Vironostika HIV-1 Microelisa System screening test manufactured by Organon Teknika Corp.
Approval Date: 6/3/96
Applicant: OraSure Technologies, Inc, Bethlehem, PA
Product: OraQuick Rapid HIV-1 Antibody Test
PMA number: BP010047
Indication for Use: Detection of HIV-1 antibodies in fingerstick whole blood specimens
Approval Date: 11/7/2002

Эта же фирма есть в списке, но только по поводу ВИЧ-1. Кстати, они в своих сайтах указывают, что уже получили утверждение, и ФДА в своей информации предупреждает легковерных. Системы в стадии испытаний, но, возможно, они продаются (4-стадия предусматривает широкий охват ).