COVID-19 Rapid Diagnosis System
Diagnovir Rapid Diagnosis System is in vitro diagnostic medical device. It is a specific diagnostic system produced specific to COVID-19 (SARS-COV-2), which is easy to use and gives rapid results. Diagnovir test device (analyzer) consists of transfer kit (transfer tube, swab) and analysis kit.
The new nanotechnology-based diagnostic system can detect the COVID-19 virus in less than a minute with a swab taken from the mouth and just from the nasal vestibule. It is an optically based diagnostic and identification system that changes the color of the glow in the presence of the virus, thus detecting viruses with high selectivity. In this system, pathogens are detected in less than a minute by dynamically receiving a fluorescent signal via a pathogen detection chip developed specifically for a biosensor device. After samples taken from the patient, it is mixed with a special solution, dropped on the pathogen detection chip, and if there is a pathogen in the environment by the biosensor device, the presence of pathogens with high accuracy is detected by taking the fluorescent signal. Taking saliva samples from the mouth and mucosa samples from the nasal vestibule instead of taking swab samples from deep areas such as the oropharynx and nasopharynx will also make the use of the system preferable. Unlike the commonly used tests, the system is not based on sample replication, but on detecting the presence or absence of the virus with advanced optical methods. In the system, optical and electronic modules that provide both precise virus detection and high selectivity in detection, as well as high-level biotechnology and material science knowledge are used. The system has shown 99% success in virus detection.
In less than a minute, Diagnovir has a 99% reliability rate, eliminating the need for deep swabs used in current tests, providing accurate results even at the first time of the disease, being economical, working even with the presence of nano-level viruses, protecting healthcare teams and being able to be used in the detection of other pathogens in the future. It is a powerful alternative to the commonly used tests in coronavirus diagnosis.
INTENDED USE OF THE PRODUCT
The product is designed to detect Covid-19 (SARS-COV-2) virus with a saliva sample taken from the oral cavity (eg; inner cheek) and nasal cavity (just the nasal vestibule) via Diagnovir Antigen Rapid Diagnostic Test.
The device can only be used for in vitro Covid-19 (SARSCOV-2) diagnostic purposes with Diagnovir Analysis Kit and Transfer Kits
COLLECTION AND TRANSPORT OF SAMPLES
The swab stick included in the transfer kit should be collected from the oral cavity and by entering 1-2 cm from the nasal cavity of the person to be diagnosed. The swab is placed in the transfer tube without touching anywhere. It is removed from the tube turning right and left for 10 seconds, the used swab is thrown into the medical waste box and the cover of the transfer tube is closed. 1 drop of sample from the solution in the transfer tube is added to Diagnovir Analysis Kit. (One drop of the transfer tube is set to drop 20μL of sample)
Product Name: Diagnovir COVID-19 Rapid Diagnosis Kit (With Device)
Device: Diagnovir Analyzer
Test System Content: Analysis Kit (Test Chip)
Transfer Kit = Transfer Tube + Swab Stick
(Solution Tube) (Swabs)
Number of Analysis Kits: 30 Pcs/Package
Sampling: Oral cavity (eg; inner cheek) and nasal cavity (just the nasal vestibule)
Test Period: < 1 min.
Analysis Kit Shelf Life: 1 year under proper storage conditions
Storage conditions: 10-95% relative humidity, temperature 10-50℃
Working conditions: 30-85% relative humidity, temperature 10-40℃
For Analysis Kit
Storage Conditions:10-95% relative humidity, temperature 2-8℃
Operating Conditions: 30-85% relative humidity, temperature 10-40℃
For Transfer Kit
Storage Conditions : 10-95% relative humidity, temperature 4-30℃
Operating Conditions : 30-85% relative humidity, temperature 10-40℃