Icosagen AS
 
작성일 : 12-11-25
[Icosagen AS] Natural rubber latex allergens 검출 키트, FITkit®
Immunological test kit for measuring NRL(natural rubber latex) allergens
 
Natural rubber latex(NRL) allergens 검출 키트, FITkit®
 
Immunological test kit for measuring NRL(natural rubber latex) allergens
 
 
 
지난 20년 동안 NRL(Natural rubber latex) 알레르기 환자 수는 의료종사자의 17%, 전체 인구의 약 1%에 달해 세계적으로 심각한 문제가되고 있습니다.  NRL 알레르기의 증상은 주로 접촉성 두드러기이지만시, 심한 경우 과민성 쇼크를 일으켜 사망을 초래할 가능성도 있습니다.  의료용구(장갑, 마스크 등)은 주로 NRL로 만들어져 있기 때문에 주로 의료 종사자와 환자에게 알레르기가 많이 나타나고 있으나, NRL로 만들어진 풍선과 장난감 등을 접할 기회가 있는 사람에게는 누구나 알레르기가 나타날 수 있습니다.
 
FITkit® 시리즈는 다양한 물질(latex 장갑, catheter, dental dams, 풍선, 장남감 등)에서 NRL allergen을 감지 할 수 있습니다. 각 allergen의 단클론 항체를 이용하므로 간섭 또는 교차 반응을 일으키지 않고, 감수성이 높고, 훌륭한 결과를 얻을 수 있습니다.
 
 
 
 
 
 
FITkit® is an immunological test for measuring natural rubber latex (NRL) allergens from a variety of rubber products, such
as gloves, condoms, teats etc. This novel method is the first ever test for the measurement of clinically relevant NRL
allergens, and enables quantification of individual allergens. FITkit® technology is compliant on the ASTM International
standard D7427-08.
 
A separate FITkit® is available for measuring each of the major allergens: Hev b 1, Hev b 3, Hev b 5 and Hev b 6.02.
 
Applications of FITkit test vary from producers R&D or quality control needs to measure latex allergens in finished
products or those in different phases on production line, assess production development to different distribution
organizations purchasing departments tool of quality criteria. Newer approach has found FITkit applicable to synthetic
products contamination control. If absence of major NRL allergens in synthetic protective gloves or in other synthetic
rubber products with medical purpose of use requires verification, implementation of FITkit has offered a useful solution.
 
 
Features ;
  • Direct measurement of the relevant allergens individually
  • Unique sensitivity
  • Consistent and reliable results
  • Convenient procedure  and short assay time (< 2 hours)
  • No interference from other substances
 
 
Natural rubber latex allergens
 
Liquid latex from the rubber tree, Hevea brasiliensis, is the source of NRL and contains over 200 proteins; only 14 of
them have been identified as allergens. Only some allergens retain their allergenic properties through the manufacturing
processes. Thus, when trying to reduce the allergen content of NRL products, any good testing method must measure
all components with clinical relevance present in the final product. The NRL allergens that have been shown to be
clinically relevant to genuine NRL allergy, and present in the final NRL products with maintained allergenicity are Hev b 1,
Hev b 3, Hev b 5 and Hev b 6.02. According to latest studies, quantification of these four major allergens shows the
allergenic potential of rubber products.
 
 
References ;
  • Turjanmaa, K. et al., Allergy 51 (1996) 593 – 602;
  • Liss, G. M. and Sussman, G. L., Am. J. Ind. Med. 35 (1999) 196 –200
  • Poley Jr, G. E. and Slater, J. E., J. Allergy Clin. Immunol. 105 (1997) 1054 – 1062
  • Palosuo, T. Alenius, H. Turjanmaa, K: Quantification of Latex Allergens. Methods 27 2002; 52-58
  • Palosuo, T. et al, Latex allergy: the sum quantity of four major allergens shows the allergenic potential of medical gloves. Allergy, 2007, 62:781-786
  • International Union of Immunological Societies allergens list: http://www.allergen.org.  (Home> Plantae magnoliopsida > Malphigales > Hevea brasiliensis)
 
 
FITkit as a tool in risk management
 
 
Why do we need the latex allergen measurement tests (FITkit, ASTM D7427) at all?
 
The history of natural rubber latex (NRL) as the prime glove source material, with its excellent barrier and other
properties, is well known. Furthermore, a literature review reveals that NRL gloves, when compared with alternatives,
tend to be stronger, more flexible and preferred by some clinicians. Also, we utilize on a daily basis many other latex
products in healthcare and as consumers. However, NRL gloves have been under pressure for more than 20 years due to
the risk of allergies. Improvements in glove manufacturing and more extensive use of synthetic gloves have led to a marked decrease in allergy cases in developed countries in Europe and North America. Notwithstanding this diminishing trend, the
risk of allergy continues to be considered in every hospital’s risk management policy. In order to assess the source of
potential sensitization (a glove for instance), we need a tool for assessment. Since the total protein (ASTM 5712) or
antigenic protein (ASTM 6499) assays do not provide definitive data for the presence of allergenic proteins, the FITkit or
ASTM D7427 are the only currently available methods to directly provide this information. Specific allergen measurement
is considered the best option to assess potential risks of medical gloves (REF 1). A number of scientific reports reveal that
rubber products fulfilling the requirements for total protein (< 50 µg/g) or antigenic protein (<10 µg/g) can still contain
clearly significant concentrations of allergenic latex proteins (REF 2-6). Therefore, data on the allergen content of gloves
should be made available, and gloves with high allergen content (sum quantity of four major allergens over 1.15 µg/g,
(REF 7)) should not be recommended.
 
 
What is the difference between ASTM D7427 and FITkit?
 
ASTM D7427-08 is an ASTM standard defining properties of a generic test that allows for the reliable measurement of
clinically relevant latex allergens, Hev b 1, 3, 5 and 6.02, respectfully. ASTM has made available Industry Reference
Materials and guides via D7427 standard text, allowing everyone interested to create their own assay. FITkit is a
commercially available test that is compliant with ASTM D7427. FITkit is available as ready-to-use test reagents or a
testing service.
 
 
Impact of FITkit data on the quality of risk management
 
FITkit test data helps to reliably differentiate gloves (or any other latex products) with proven low allergen content from
others. Furthermore, available information about the allergen content of latex gloves raises the credibility of the
producer’s or distributor’s statement about glove properties. Logically, it will significantly improve users’ ability to choose
low allergen content gloves. This practice, on the other hand, will reduce the use of high allergen content gloves and,
in turn, lead to a decrease in the exposure of people to latex allergens. There are available reports revealing whether
gloves contain less than 0.15 µg/g (FITkit detection) of clinically relevant allergens, making it more than likely that they
can be used safely. Furthermore, products that contain such small amounts of the studied natural rubber allergens are
very likely suitable for a significant number of sensitized users, and the use of these gloves is not likely to create a risk in
most persons unaware of their allergy (REF 8, 9).
 
 
How can one be sure that the use of high quality protective gloves poses a minimal but acceptable risk for latex sensitive users?
 
Available guidelines typically recommend choosing synthetic alternatives instead of NRL gloves for sensitised users. At the same time there has been a search by manufacturers and health authorities for a methodology that would allow verifying
that synthetic products are free of NRL. The latex-free definition is becoming more complicated, as it is usually based only
on a manufacturer’s announcement, not on reliable test results. Synthetic gloves are recommended as safer alternatives,
because they, by definition, do not contain NRL proteins. A recent publication by M. Angeles Gonzalo Garijo et al
(REF 10) on NRL contaminated nitrile gloves in healthcare shows that this is sometimes not true. In this respect, to fulfil a
recommendation of being safer alternatives, synthetic gloves should be verifiably clean of NRL, i.e. under periodical
control. Currently, FITkit or D7427 would be a suitable method to convincingly demonstrate the absence of the four
major NRL allergens in gloves or other rubber products, when the need for such a statement emerges.
 
 
How gloves with proven low allergen content influence public safety?
 
Knowledge of the allergen content of available gloves will significantly improve users’ ability to choose low allergen
content gloves. This practice, on the other hand, will reduce the use of high allergen content gloves and, in turn, lead
to a decrease in the exposure of people to latex allergens. Eventually this development could have a marked public
health impact by further reducing the incidence of new cases of latex allergy. Limitations in predictability of sensitization
to NRL and resulting allergic reactions should not preclude attempts to overcome the problems associated with assessing
potential exposure risks to products containing NRL allergens. Latex allergen measurement is one of the specific tools
available for overcoming latex allergy concerns.
 
 
References:
  • Tomazic-Jezic, V. et al. Performance of Methods for the Measurement of Natural Rubber Latex (NRL) Proteins, Antigens and Allergens. J Allergy Clin Immunol 2004:113:S211
  • Kostyal, D. et al. Latex as a significant source of Hevea brasiliensis allergen exposure. Ann Allergy 2009
  • Yagami, A. et al. Hev b 6.02 is the most important allergen in HCW Sensitized Occupationally by NRL gloves. Allergology International 2009; 58:347-355
  • Mabe, D.O. et al. Allergenicity of latex rubber products used in South African dental schools. S Afr Med J 2009; 672-674.
  • Mok, K.L. Immunological Measurement of Four Major Allergens in Natural Rubber Latex Medical Gloves. 5th International Rubber Glove Conference 2010 paper
  • Koh, D.  et al. A study of natural rubber latex allergens in gloves used by healthcare workers in Singapore British Journal of Dermatology 2005 153, pp954–959
  • Palosuo, T. et al. Latex allergy: the sum quantity of four major allergens shows the allergenic potential of medical gloves. Allergy 2007; 62:781-6.
  • Turjanmaa, K, Kanto, M., Kautiainen, H., Reunala, T., Palosuo, T. Long-term outcome of 160 adult patients with natural rubber latex allergy. J Allergy Clin Immunol 2002; 110:S70-4.
  • Glove study 2005. Finnish National Agency for Medicines, www.nam.fi/english/publications.
  • Gonzalo Garijo M. A. et al. Hypersensitivity reactions due to nitrile gloves, J Allergy Clin Immunol 2011
 
 
Ordering information ;
 
Catalog No.
Product Name, Brochure (PDF)
Detection Limit
K3-350-020
FITkit® Hev b 1, Brochure (PDF)
1.2μg / L
K3-350-030
FITkit® Hev b 3, Brochure (PDF)
2.3μg / L
K3-350-040
FITkit® Hev b 5, Brochure (PDF)
0.5μg / L
K3-350-010
FITkit®  Hev b 6.02(Hevein), Brochure (PDF)
0.1μg / L
 
Each kit contains all reagents ready to use for testing 41 duplicate samples. These highly sensitive tests use specific
monoclonal antibodies developed against the clinically relevant latex allergens present in NRL products. The kits show
good correlation to the allergen content of gloves, measured by currently available patient IgE methods.