n-FasT Fast-PCR Covid Test Kit

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SKU:
NG11FBX
  • n-FasT Fast-PCR Covid Test Kit
  • n-FasT Fast-PCR Covid Test Kit
  • n-FasT Fast-PCR Covid Test Kit
  • n-FasT Fast-PCR Covid Test Kit
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Description

The n-Fast rapid diagnostic kit using colorimetric technology, allowing the result to be obtained within 30 minutes after swabbing. Thanks to the colorimetric technology, the result is easily visible and distinguishable.

The 8 mixes in the kit are mixed in appropriate proportions (proportions and key points are included in the prospectus) and the swab samples are added and placed in a dry heating block. Color change is observed within 30 minutes.

There are 100 reactions in the n-FasT kit, in which 100 people can be tested with a box of n-FasT. The swab (100 pieces) required to take the swab sample and the Vnat solution (100 pieces) to store the sample until the test is sent with the n-FasT.

For detailed information, you can write to info@nanografi.com

The N-FasT Covid-19 diagnostic kit, which was developed by Nanografi Nano Teknoloji A.Ş., tested by Hacettepe University Faculty of Medicine, and approved by the Public Health Center, was produced with a much higher performance than all the qualities of its counterparts after an intensive R&D study. The reaction, which is performed without the need for a PCR device, can produce results within a period of 30 minutes after swabs. N-FasT, which emerged with the support of advanced nano technology materials, shows superior performance values ​​than all the kit studies currently carried out in the world.

Unlike rapid antibody diagnostic kits and screening kits with long-term results and low accuracy, the N-FasT diagnostic kit differs from its counterparts with the advantage of being able to give results at the bedside after swab collection. The N-FasT test kit, which eliminates the negativities such as long queues in screening tests, public health risk caused by free movement of positive cases when they wait for results after swab operations, costs, limited number of tests that can be performed in a limited time, will be able to respond quickly to high volume needs with its ease of mass production. . . With an accuracy rate of more than 98% in the screening test at the bedside, the N-FasT diagnostic platform will be an important solution in other diagnostic kits.

All scientific and bureaucratic process in Turkey towards the use of diagnostic kits had successfully completed the required eligibility for the use in worldwide completed. For detailed information about the n-FasT diagnostic kit, you can write here.

The n-FasT diagnostic kit, which is brought into use with high performance values ​​as a result of intensive R&D studies of expert scientists in the field, contains a transformable-functionalized technology for different infections. The platform of n-FasT technology, which will open a new era in diagnostic technologies, can be used for common infections in the society, especially influenza. Nanografi will continue to provide effective solutions in other areas where it is needed by meeting the diagnosis need for Covid-19.

 LAMP Lights Up COVID-19 Testing

The N-FasT diagnostic kit, which successfully passed all tests and performed clinical trials at Hacettepe University and approved by the Public Health Center, was approved by the relevant authorities of the Ministry of Health. Nanografi Nano Teknoloji A.Ş., which has Medical Device Sales Center Authorization Certificate approval. will meet the needs with the assurance. With its expert engineers, researchers, sales support experts, Nanografi Nano Teknoloji A.Ş. continues its biotechnology studies on preventive and diagnostic studies in the fight against Covid-19. Click to get information.

 

 

The n-FasT is a manual method utilizing loop-mediated isothermal amplificaton (LAMP) technology to detect SARS-CoV-2 viral RNA qualitatively. The test uses one specific SARS-CoV-2 set, designed to uniquely detect SARS-CoV-2 RNA.

Gently mix each component by pipetting. Ensure that any formation of bubble is resuspended.

RNA is isolated from upper respiratory specimens using a swab kit. Extracted RNA is transferred to PCR tube and RT-LAMP reaction is set up on a heat block. Incubation and data collection is performed on NGLab Heat Block.

Master mix, Primer mix, Reagent A1, Reagent A2, Positive and Negative controls and Quicklysis Buffer are mixed and placed on a cold rack at 4-8°C on ice. Storage conditions of n-FasT should be at -20°C before using test.

Swab specimens are placed in a tube containing VNAT solution. 10µl of VNAT and swab specimen is mixed with Quicklysis buffer. This mixture is incubated for 5 minutes at 95°C and then 1µl of each individual reaction is mixed with a mixture prepared with solutions described  in Table 1 and incubated at 65°C for 5 minutes. Allow reactions to cool from 65°C for 5 minutes for improved color contrast. DO NOT open the reaction vessels.

The n-FasT is a real-time reverse transcription polymerase chain reaction (rRT -PCR) test.  The SARS-CoV-2 primer and probe set(s) is designed to detect RNA from the SARSCoV-2 in nasopharyngeal and oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider. Sequences and formulas for each primer are indicated below: 

 

COMPONENT

#1.

NO TEMPLATE CONTROL

#2.

POSITIVE

CONTROL

#3.

SARS-CoV-2

TEST SAMPLE

Master Mix

18.5 µl

18.5 µl

12.5 µl

Primer Mix

2.5 µl

2.5 µl

2.5 µl

Reagent A1

2.5 µl

2.5 µl

2.5 µl

Reagent A2

0.5 µl

0.5 µl

0.5 µl

SARS-CoV-2 Positive Control

(Quicklysis Buffer + VNAT)

-

1.0 µl

-

Negative Control (Quicklysis Buffer + VNAT)

1.0 µl

-

-

Test Sample

1.0 µl

Verify that all starting reactions are pink. A sample can only be judged fort he presence or absence of SARS-CoV-2 RNA if the NC reaction is fuchia and PC reaction is yellow. 

 

Required But Not Included Equipment/Materials

Disposable powder-free gloves and any additional PPE required

P2/P10, P200, and P1000 aerosol barrier tips

Sterile, nuclease-free 1.5 ml microcentrifuge tubes

Sterile, nuclease-free 0.6 ml tubes

0.2 ml PCR reaction tube

Acceptable surface decontaminants, for example: (dilution of commercial 70% ethyl alcohol)

Laboratory marking pen

Appropriate disposal containers

White paper or light background for optimal visualization of colorimetric reaction (e.g., typical printer paper)

Micropipettes (2 or 10 μl, 200 μl and 1,000 μl)

-20°C Freezer (frost-free or nonfrost), 4°C Refrigerator

Thermocycler, heat block or device that can be set to 65°C

Internal Control (optionally can be purchased from NG Genetics)

Controls that will be provided with the test kit include:

a)      Negative Control (NC): contains Quicklysis Buffer + VNAT intended to evaluate cross contamination of the kit, supplements, reagents and PCR instrument used in the test.

Detection accuracy can be evaluated with the NC. The Negative control should be run using 1 µL in one well per test.

 b)      Positive Control (PC):contains plasmids with insert of SARS-CoV-2 N gene that is intended to evaluate RNA extraction and Analytical and Clinical performance of the kit.

The positive control should be run using 1 µL in one well per test.

 

n-FasT KIT CONTENT

 

 

 

1-      Master Mix. : First solution with a pink color. 

2-      SARS-COV-2 Primer Mix. : Transparent, second solution.

3-      n-FAST Reagent A1 : Transparent, third solution.

4-      n-FAST Reagent A2 : Transparent, fourth solution. 

5-      Positive Control : Fifth, transparent and red capped solution.

6-      Negative Control : Transparent, sixth solution.

7-      Quicklysis Buffer : Seventh solution that exposes the RNA in the virus.

 

Reaction Component

Volume (1X)

For 1 Tube

Volume (2X)

For 2 Tube

Volume (3X)

For 3 Tube

Volume (4X)

For 4 Tube

Volume (5X)

For 5 Tube

n-FasT Mix

18.5 µl

37 µl

55.5 µl

74 µl

92.5 µl

SARS-COV-2 Primer Mix (10X)

2.5 µl

5 µl

7.5 µl

10 µl

12.5 µl

n-FasT Reagent A1 (10X)

2.5 µl

5 µl

7.5 µl

10 µl

12.5 µl

n-FasT Reagent A2 (50X)

0.5 µl

1 µl

1.5 µl

2 µl

2.5 µl

Sample (From the solution in 3rd step)

1 µl

1 µl

1 µl

1 µl

1 µl

Total (Total volume for one tube)

25 µl

25 µl

25 µl

25 µl

25 µl

 

n-FasT WORKING PROCEDURE

  1. Before starting to work, all the surfaces and materials should be cleaned with alcohol and sterilized.
  2. Set the dry block heater device to 95ºC. (You can adjust the temperature with the up and down buttons on the device.)
  3. Place the swab samples taken into the virus inactivation solution. Shake the tube so that the (VTM or VNAT) Covid-19 virus particles mix into the solution.
  4. Transfer 10 µl of Quicklysis Buffer to a sterilized, 0.2 mL tube with the inactivated virus solution (VTM or VNAT) containing 10 µl of swab samples and mix by pipetting.
  5. Leave the tube in the dry block heater that you have preset at 95ºC for 5 minutes.
  6. At this stage, the solutions in the kit are prepared using the table below. These steps should be carried out on ice.
  7. Leave the tube at 65 ° C for 30 minutes to start the screening reaction.
  8. Check the solution for color changes.
  9. A significant color change can be observed in samples of patients with severe symptoms after 15 minutes (yellow color).
  10. Working time normally lasts 30 minutes and negative samples are observed in pink color while positive samples are observed in yellow.
  11. Positive and negative control must be studied in every reaction. Red-like fuchsia/pink color: Covid-19 Negative / Yellow color: Covid-19 Positive
  12. At the end of the reaction, a more homogeneous color can be observed by resting your tubes on ice or at +4 ° C for 1-3 minutes. (Observe within 30-60 seconds on a white background at room temperature.)
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Additional Information

Reaction Unit:
100
Swab Pick:
100
Vnat:
100
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