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Diagnovir

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.

 

USAGE RESTRICTIONS

The device can only be used for in vitro Covid-19 (SARSCOV-2) diagnostic purposes with Diagnovir Analysis Kit and Transfer Kits

  • The test should be used in accordance with the instructions of the user manual,
  • The test can be performed by a trained health professional,
  • Eating or drinking is forbidden within 15 minutes before the test,
  • If there is a piercing, it must be removed.

 

 

 

 

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)

 

SAMPLING STAGES

  • Make sure that the person to be tested has not eaten or drank anything until 15 minutes before the test,
  • If there is a piercing, it must be removed,
  • Take a swab from the oral cavity (eg inner cheek) and nasal cavity (just the nasal vestibule) with a swab,
  • Open the transfer tube cover and dip the sampled swab into the solution,
  • Turn the swab right and left for 10 seconds, wait a few seconds,
  • Remove the swab stick and throw it into medical waste,
  • Drop 1 drop from sample into test kit.

 

DIAGNOVİR

  • It is faster,
  • Does not need a deep swab,
  • High accuracy rate,
  • Does not require a laboratory environment,
  • Gives correct results from the first moment of the disease,
  • It is safe,
  • It can be used in the detection of other pathogens in the future.

 

 

 

PRODUCT CONTENT

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:

 

For Analyzer

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℃