Hi, rathiagaraja-ga:
I found two manufacturers of microalbuminuria test kits from this
site:
[Diabetes Forecast - Resource Guide 2003 Urine Testing]
(see second page)
http://www.diabetes.org/main/community/forecast/ResourceGuide2003/2003ResourceGuide_PDF/UrineTest.pdf
[ADA Resource Guide - Manufactures and Exclusive Distributors]
http://www.diabetes.org/main/community/forecast/ResourceGuide2003/Manufacturers.jsp
The first is Matria Laboratories (Matria Healthcare):
Matria Laboratories, Inc.
P.O. Box 2975
Shawnee Mission, KS 66201
1-888-593-2747
Fax: 1-877-836-5089
www.matria.com
whose product is called Appraise Microalbumin Diabetes Monitoring
System (formerly manufactured by ChoicePoint Health Systems, Inc.).
The second is FlexSite Diagnostics, Inc.
FlexSite Diagnostics, Inc.
3543 SW Corporate Pkwy.
Palm City, FL 34990
(772) 221-8893
1-877-212-8378
info@flexsite.com
www.flexsite.com
whose product is called KidneyScreen at Home:
[KidneyScreen at Home]
http://www.flexsite.com/images/kidney2.jpg
Detection of microalbumin (protein) in urine is an early indication of
kidney damage. These test kits can be purchased over-the-counter and
self-collected at home, but require laboratory processing and
physician interpretation of the results. In this respect these
procedures are more cumbersome than those for detecting glucose and
ketones in urine.
Many urine test strips include a panel for detecting protein,
including some by Roche (Chemstrip) and Bayer (Uristix et al, such as
Ames Multistix) which you are already aware of. Here is an additional
manufacturer of products of this kind:
[Quidel (Quickvue Urinchek)]
http://www.quidel.com/Products/productdisp.php?prod=69§ion=pro
Note that certain urine test strips manufacutured abroad are subject
to US import blocking for what the FDA considers improper labelling,
in particular the use of "metric" units of measurement:
[Import Alert - Urine Test Strips]
http://www.fda.gov/ora/fiars/ora_import_ia7501.html
With this caveat I can point out an additional manufacturer of urine
test strips which detect protein, BHR in England:
BHR
BHR Pharmaceuticals Ltd
41 Centenary Business Centre
Hammond Close
Attleborough Fields, Nuneaton
Warwickshire
CV11 6RY
Tel: (024) 7635 3742
Fax: (024) 7632 7812
Email: info@bhr.co.uk
whose product is called Medi-Test Protein 2.
The use of regular urine reagent test strips for the detection of
microalbuminuria has been the subject of some critical medical
studies:
[The utility of conventional dipsticks for urinary protein
for screening of microalbuminuria in diabetic patients]
http://www.clib.psu.ac.th/acad_43/ssup1.htm
[Screening for microalbuminuria in type 2 diabetic patients:
the evaluation of a dipstick test in general practice]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=7587002
I hope these links provide the information you were seeking. If
additional information is needed, please use the Request for
Clarification feature.
regards, mathtalk-ga
Search Strategy
Keywords: urine test strips protein manufacturer
://www.google.com/search?hl=en&lr=&ie=UTF-8&oe=UTF-8&q=urine+test+strips+protein+manufacturer&btnG=Google+Search
Keywords: Matria Laboratories
://www.google.com/search?hl=en&ie=UTF-8&oe=UTF-8&q=Matria+Laboratories&btnG=Google+Search
Keywords: "appraise microalbumin"
://www.google.com/search?hl=en&ie=UTF-8&oe=UTF-8&q=%22appraise+microalbumin&btnG=Google+Search |
Request for Answer Clarification by
rathiagaraja-ga
on
16 Jul 2003 00:56 PDT
Dear Mathtalk
Thank you for your update. I just wonder whether you can source
for Microalbuminuria test strips manufacturers from India, Taiwan,
Korea and Italy.
I will appreciate your contribution.
Thanks
Regards
RA.Thiagaraja
|
Clarification of Answer by
mathtalk-ga
on
16 Jul 2003 10:16 PDT
Hi, rathiagaraja-ga:
Just to be sure, you are interested specifically in the
microalbuminuria test kits, and not in the much more widely available
protein urine test strips?
thanks, mathtalk-ga
|
Request for Answer Clarification by
rathiagaraja-ga
on
16 Jul 2003 19:46 PDT
Dear Mahtalk
Currently Im only interested with Microalbuminuria test strips. (
Most Needed). But at the same time if the Manufacturer has proteinuria
strips I will considers as well if their price is acceptable.
Priority will be Microalbuminuria test strips.
Thanks
Regards
RA.Thiagaraja
|
Clarification of Answer by
mathtalk-ga
on
17 Jul 2003 10:06 PDT
Hi, rathiagaraja-ga:
This may be of interest. I located another manufacturer of
microalbuminuria test strips, this time a Canadian firm (with US
presence) called Diagnostic Chemicals Limited:
Diagnostic Chemicals Limited
800-565-0265 (Canada) - Charlottetown, PE, Canada C1E 2A6,
902-566-1396
Fax 902-566-2498
800-325-2436 (USA) - Oxford, Connecticut, USA 06478, 203-881-2020
Fax 203-888-1143
e-mail: sales@dclchem.com
http://www.dclchem.com
whose product is called ImmunoDip Stick for Microalbuminuria:
[ImmunoDip Stick - CLIA Waiver]
http://www.dclchem.com/Diagnostic/Reag_Lit/790-700.1SP%20waived.pdf
I'm unclear about how you mean to extend the question, which initially
asked about identifying additional urine test strip manufacturers
besides Roche and Bayer.
Because you raised the issue of "price", I'm wondering if the focus
should be on the location of suppliers, rather than manufacturers. It
would normally be the best approach, particularly in a geographically
isolated region, to establish a market presence through a wholesale
outlet for a product (rather than through retail channels).
I had originally understood your main interest to be manufacturers and
the corresponding differences in technology and effectiveness.
Also, please shed some light on the specific countries named (India,
Korea, Taiwan, and Italy). Are you interested in manufacturing or in
supply? Are you equally interested in finding a "source" for each
country, or simply in finding one country which has a manufacturer (or
supplier)?
regards, mathtalk-ga
|
Request for Answer Clarification by
rathiagaraja-ga
on
19 Jul 2003 00:02 PDT
Dear Mahtalk
Thank you for your reply. I would like to know manufacturers (
first choice) because they should be able to provide full support for
any clarifications in future.
But if u cant source manufacturers then suppliers will do but
they have to be a reliable suppliers . I'm looking for a manufacturers
and suppliers from India, Korea , Taiwan and Italy. I want to know
from above mention countries therefore I can compare and source most
reliable and ecceptable quality.
I would appreciate if could assist me on this.
Thank You
Reagards
RA.Thiagaraja
|
Clarification of Answer by
mathtalk-ga
on
19 Jul 2003 09:40 PDT
Hi, rathiagaraja-ga:
I believe that in order to provide the assistance you request, a great
deal more time would need to be spent than is commensurate with the
list price that you offered for this question.
Originally you posted a question asking about manufacturers, other
than Roche and Bayer, of "test strips to test for microalbuminuria and
protein uria". I was able to identify some additional manufacturers
of both kinds. Certainly this demonstrates that a variety of
proprietary products are available.
You now want further assistance with "Microalbuminuria test strips
manufacturers from India, Taiwan, Korea and Italy". Before proceeding
it would probably be a good idea to pin down some definitions and
assumptions. A 1999 study in the British Medical Journal:
[Systematic review of near patient test evaluations in primary care]
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=28237
defines "near patient testing" in this way:
"Near patient testing is defined as any investigation carried out in a
clinical setting or the patient's home for which the result is
available without reference to a laboratory and perhaps rapidly enough
to affect immediate patient management."
This study references a 1995 paper comparing the efficacy of Roche's
Micral test, "a semiquantitative dipstick test," versus a quantitative
nephelometer in screening for microalbuminuria:
[Screening for microalbuminuria in type 2 diabetic patients: the
evaluation of a dipstick test in general practice.]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=7587002
The results, based on three days of repeated tests using both
techniques, were that the Micral test produced a false negative in 30%
of cases where microalbuminuria is present and a false negative in 10%
of cases where it is not present. (An additional "Area under Curve"
analysis is suggested for improving on the Micral test's predictive
power.)
Roche's Chemstrip Micral test strips are packaged 30 to a "bottle",
for which the retail price is (in round numbers) $100. Roche in this
case is sometimes referred to by Boehringer Mannheim Diagnostics, a
subsidiary acquired in 1997, as for example here:
[DCL's ImmunoDip vs. Roche's Micral test strips]
http://www.dclchem.com/Pointofcare/immunocomp.htm
DCL's claims suggest that their ImmunoDip "dipstick" devices are
significantly more accurate than Roche's Micral strips and easier to
use. DCL packages these in a unit of 25 individual foil pouches.
In any case we would clearly group ImmunoDip and Micral test strips as
relatively similar "semiquantitative test" products In contrast
Bayer's Micro-Bumintest, as illustrated by this DCL comparison, is
considered qualitative:
[DCL's ImmunoDip vs. Bayer's Micro-Bumintest]
http://www.dclchem.com/Pointofcare/immunocomp2.htm
Indeed the ImmunoDip and Micral tests are so similiar in "methodology"
that they share a Current Procedural Terminology (CPT) code, 83518QW,
by FDA directive:
[Medicare Report: September 2002]
(see under Speciality News subsection, about 1/8th of the way down)
http://www.hgsa.com/professionals/med-reports/mr0902-m.html
I was unable to find a price quote on the Web for DCL's ImmunoDip
stips, but this article gives a favorable price comparison between
ImmunoDip and Micral:
[Microalbuminuria Advice by George Bakris]
http://www.physiciansmarketplace.com/AdviceBakrisMicroalbuminuria.htm
"ImmunoDip® is a new generation immunoassay dipstick specifically
designed to detect the lower levels of albumin in spot urine in an
office or clinic setting. The sensitivity of this test ranges from
98%-100%, with a specificity of 96%-98%.7 The cost of the ImmunoDip is
$3.00-$4.00 per test and offers the advantage of a built-in control to
ensure confident test results. This method also incorporates
self-sampling and self-timing features to reduce operator error.
"The Micral II® is a dipstick method again specifically designed to
detect the lower levels of albumin in the spot urine. The sensitivity
of the test ranges from 88%-95%, with specificity of 92%-95%.8 The
cost of microalbumin determination using the Micral II® stick ranges
from $4.00-$7.00 per strip used."
This article partly addresses the international availability of DCL's
ImmunoDip:
[Rapid Diagnostics: When Time Is Of The Essence]
http://www.responsebio.com/media/mapr00.htm
"Headquartered on Prince Island, Diagnostic Chemicals Limited has
developed and patented its innovative ImmunoDip® device for running
immunochromatographic assay strips...
"The ImmunoDip Test for Urinary Albumin is sold for clinical use in
Canada, the United States, Japan, the United Kingdom and Spain. DCL
seeks distribution and marketing partners in other regions of the
world and expects to receive regulatory clearance in the U.S. shortly
for Physician's Office use and, longer term, for home testing."
While I was also able to find a reference for ImmunoDip's availability
in Brazil, I did not find specific availability in Italy, Korea,
Taiwan, or India. Nonetheless the above shows that Mediterranean and
Asian suppliers do exist, and that at least some work is ongoing in
seeking regulatory approval in other markets.
Which brings me back to the crux of my suggestion. If you would like
assistance in contacting manufacturers to check availability of their
products in the four countries named (Italy, Korea, Taiwan, and
India), this effort will be a great deal more costly than the $10 you
offered (and I accepted) for the original question, that did not
require such contacts to answer. The best approach, in my opinion,
would be to post a new question stating your more specific goals (and
perhaps referencing this thread for the sake of summarizing all the
background information that I've collected for you).
For the Google Answer's pricing guidelines, please view this link:
[Google Answers: How to price your question]
http://answers.google.com/answers/pricing.html
Those guidelines suggest that a $10 question might be answered with 30
minutes of work. I hope that you have gotten a great deal of value
from the much more extensive amount of work that I've put into
answering this particular question.
This is the first question you've posted here, and I certainly want it
to be a good experience for you. Keep in mind that if you are not
satisfied with the first answer, you have an option to request a
refund within 30 days. This satisfaction guarantee is intended to
encourage you to offer a price for information commensurate with the
value it has for you. In this case the price you set does not
realistically allow me to provide further information about these
products in four different countries, and because I've already
answered the question, the price cannot be changed at this time.
regards, mathtalk-ga
|
Clarification of Answer by
mathtalk-ga
on
19 Jul 2003 10:08 PDT
Hi, rathiagaraja-ga:
Here is yet another manufacturer, Vancouver Biotech Ltd. (VBL), a
"spin-off" from the University of British Columbia:
[Vancouver Biotech LTD.]
http://www.vancouverbiotech.com/about/
General inquiries
info@vancouverbiotech.com
Mailing Address:
Vancouver Biotech LTD.
9121 Shaughnessy Street
Vancouver, BC Canada
V6P 6R9
Tel. (604) 325-4602
Fax. (604) 325-4677
[Vancouver Biotech Ltd. - Catalog]
http://www.vancouverbiotech.com/catalog/
"Vancouver Biotech LTD is growing very rapidly and has committed to
expanding throughout Asia. Currently, our products are being
distributed in China, Taiwan, and Korea. Please download our 2001
product catalog."
I phoned this company and spoke with a very helpful representative,
who confirmed that the cataloged products shown are still available.
Note in particular this one:
[VBL One Step Urinary HSA Test Strip]
http://www.vancouverbiotech.com/products/diagnostic/hsa.pdf
"VBL ONE STEP Urinary HSA Test Strip is a colloidal gold/antibody
complex
based immunoassay designed for the semi-quantitative determination of
human
serum albumin (HSA) in urine. It is intended for the early detection
of
microalbuminuria (slightly elevated quantities of albumin in urine)
before the
appearance of overt symptoms of renal disease."
Other than the simple drawings shown there, I was unable to find an
illustration of this product on the Web. The company's representative
encouraged inquiries by direct email on the topics of interest to you,
ie. pricing in markets such as Italy, Taiwan, Korea, and India.
regards, mathtalk-ga
|
Clarification of Answer by
mathtalk-ga
on
19 Jul 2003 10:29 PDT
This appears to be a supplier based in Italy of many medical products:
[DiagnosticWorld.IT]
http://www.diagnosticworld.it/
Among the products that they carry is this:
[One-Step Urinary Albumin Cassette Test]
http://www.glysby.com/nuova_pagina_10.htm
Although the test device is referred to as a "cassette", I believe
that this may be the same as "test strip" because of a poor
translation from the Romanance language (Italian) to English.
Elsewhere on the page we find:
"The One-Step Urinary Albumin Cassette Test strip consists of a
chromatographic absorbent device and a specific monoclonal antibody
against human serum albumin. In ten minutes, elevated levels of HAS in
the urine is detected."
regards, mathtalk-ga
|
