STD Direct Flow Chip is an in vitro diagnostic kit for the detection of pathogenic organisms causing sexually transmitted diseases (STD) in humans. The organisms causing these infections are often difficult to detect and include viruses, bacteria or parasites, usually occurring co-infections. The methods that are currently used for their diagnosis are very laborious and not always show a 100% specificity. The STD Direct Flow Chip allows the simultaneous detection of 11 pathogens: Chlamydia trachomatis1* , Haemophilus ducreyi, Herpes simplex virus 1 and Herpes simplex virus 2, Mycoplasma genitalium, Mycoplasma hominis, Neisseria gonorrhoeae, Treponema pallidum, Trichomonas vaginalis and Ureaplasma2 (urealyticum/parvum). The STD Direct Flow Chip kit allows the direct detection of these infectious agents from different types of clinical samples (urine, semen, liquid-based endocervical cytologies; and urethral, endocervical, vaginal, anal and pharyngeal swabs) without previous extraction of DNA, as well as from purified DNA of these type of clinical samples.
The STD Direct Flow Chip kit is based on a methodology consisting of the simultaneous amplification of bacterial, viral and protozoal DNA by multiplex PCR in only one step and directly from cellular extracts, followed by hybridization on a membrane with specific DNA probes using the DNA-Flow technology for HybriSpot platforms, both automated and manual. The biotinylated amplicons generated after the multiplex PCR are hybridized in membranes containing an array of specific probes for each human pathogen, as well as amplification and hybridization control probes. Unlike conventional hybridization on surfaces, the DNA-Flow technology allows a very fast binding of the PCR product and its specific probe in a three-dimensional porous environment. Once the binding has occurred between the specific amplicons and their corresponding probes, the signal is visualized by a colorimetric immunoenzymatic reaction with
Streptavidin-Phosphatase and a chromogen (NBT-BCIP), which generates insoluble precipitates on the membrane in the positions in which there has been hybridization. The results are analyzed automatically with the HybriSoft software.
STORAGE AND STABILITY CONDITIONS:
The STD Direct Flow Chip kit consists of three components that are supplied in separate boxes:
- STD Direct Flow Chip kit (PCR Reagents): Shipment at 2-8 °C*. Upon receipt, they must be stored at -2-8 °C. They will be stable until the specified expiration date. The PCR reagents must be stored in areas free of DNA or PCR products contamination. Once the package containing the tubes strip with the lyophilized PCR mix is opened, store the remaining tubes up to a maximum of one week at 2-8°C in the original package.
- STD Chips: Sent and stored between 2-8°C*. Do not freeze. The Chips are stable until their indicated expiration date.
- Hybridization reagents: Sent and stored between 2-8°C*. Do not freeze. The hybridization reagents are stable until their indicated expiration date.The hybridization reagent A must be preheated at 41°C in a thermostatic bath or heater (only for manual format) before use while The rest of the hybridization reagents must be used at room temperature (20-25°C).Once the packaging containing the chips has been opened, keep the cylindrical foam and sorbent packet inside until end of use to ensure the adequate preservation of the membranes.
Please refer to the user manual above for more detailed information.
STD Direct Flow Chip Kit (PCR Reagents) Kemenkes RI AKL 20303027804
VITRO Flow Chip Hybridization Reagents Type I (Auto) KEMENKES RI AKL 20303025507