Infectious Diseases, chlamydia, gonorrhea
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Automated Nucleic Acid Purification

NorDiag's sample preparation applications, current and in pipeline:

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Sexually Transmitted Infections
Chlamydia trachomatis is one of the most common sexually transmitted infections (STI). The national Centre for Disease Control and Prevention estimates that approximately 4 million men and women are infected by C.trachomatis in the U.S. alone each year. Chlamydial infection is easily treated with antibiotics, however, up to 75% of women and 50% of men infected with C.trachomatis are asymptomatic. Untreated chlamydial infection may have long-term consequences, especially in women in whom it is a well-established cause of pelvic inflammatory disease, ectopic pregnancy and infertility.  Therefore, routine screening and early diagnosis are essential in order to reduce the high prevalence of this infection.

Another common STI is Gonorrhoea, caused by the bacterium Neisseria gonorrhoea. Gonorrhoea grows and multiplies in moist, warm areas of the body such as the cervix, urethra, or rectum. For women, the cervix is the most common site of infection. However, it can also spread to the uterus or fallopian tubes, and can cause pelvic inflammatory disease (PID) which can lead to infertility, if untreated. Gonorrhoea can also infect the throat, rectum, and can also be spread to infants during delivery. This disease normally represents itself with mild initial symptoms, within 2 to 10 days after sexual contact. In some cases it is asymptomatic.

Diagnosis of the above microorganisms, using Nucleic Acid Technology (NAT) based detection systems, has relied on analysis using swab samples, which often require the assistance of a physician for sampling and often involves painful invasive procedures. Thus, a noninvasive method of screening for the presence of these pathogens is by the collection of urine samples. This  will promote an increase in screening and contribute to controlling the spread of Chlamydia and gonorrhoea infections. Available NAT systems, developed for C. trachomatis and Neisseria gonorrhoea diagnostics all include procedures using urine samples. However, nucleic acid preparation from urine samples has generally been associated with cumbersome manual procedures involving much hands-on time compared to the processing of swab samples, and the presence of amplification inhibitors present in urine.

BUGS´n BEADS™ STI and BUGS´n BEADS™ STI -fast, from Genpoint-NorDiag are automated methods for the isolation of DNA and RNA from bacteria causing sexual transmitted infections (Chlamydia trachomatis, Nesseria gonorrhoea, Mycoplasma genitalium and Ureaplasma urealyticum) using urine or material collected with a swab as samples.

MRSA
Hospital acquired methicillin-resistant Staphylococcus aureus (HA-MRSA), is a fast growing healthcare problem around the world. It is also becoming a problem outside hospitals, and is now an emerging pathogen as a community acquired disease (CA-MRSA). Because of the resistance to antibiotics, it is crucial to have a rapid and reliable method for detection of this organism. This will enable the correct treatment to be initiated and an immediate isolation of the patient to prevent the spread of infection. As a precautionary measure, many hospitals are isolating patients at the slightest indication of MRSA infection.  A fast and efficient method for testing would decrease the isolation time of non-infected patients and thus significantly reduce  healthcare costs.

BUGS´n BEADS™ MRSA from NorDiag is easy-to-perform and automated method for isolation of DNA and RNA from bacteria. The kit has successfully been used for the isolation of MRSA present in overnight cultures from nasal swab samples, containing antibiotics, together with analyses by PCR* amplification.

Tuberculosis
Tuberculosis (TB) is a lung disease caused by bacteria belonging to the Mycobacteria group (genus), M. tuberculosis is the most widespread. The bacterium can affect other tissues including bone, lymph nodes, brain and kidneys. It is estimated that one third of the worlds’ population is now infected with a latent form of the disease, and that 5-10% of infected individuals will develop TB at some point in their lifetime. In 2002 the WHO estimated a staggering 73 000 deaths from TB in Europe, and approximately 2 million deaths world wide.

The testing for M. tuberculosis is mainly done by microscopy and by conventional enrichment techniques. Microscopy has poor sensitivity, but represents a rapid method for screening and detecting highly infected patients. This allows for early treatment with antibiotics and the reduction of further spreading of TB. Enrichment is considered highly sensitive, but since M. tuberculosis is a slow growing organism, it can take as much as eight weeks to obtain a positive growth sample. NAT offers both a rapid and sensitive approach for TB testing. The implementation of molecular techniques in TB diagnosis has been hampered by the large amount of inhibitors present in the samples.

BUGS´n BEADS™ TB from NorDiag is an easy-to-perform and automated method for isolation of DNA and RNA from bacteria. The BUGS’n BEADS TB  kit has successfully been used for the isolation of TB present in sputum as well as other non respiratory samples, and can be combined with various downstream detection systems such as PCR*, Strand Displacement Amplification (SDA**) and NASBA*** amplification.


 

*PCR is a Registered Trademark of Roche, **SDA is a Registered Trademark of Becton Dickinson and company, ***NASBA is a Reigstered Trademark of BioMérieux