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  • 58 Minutes
    One Tube, Covid-19 and mutations detected
    OneStep RT-PCR Kit

ALL IN ONE

Has swabs, CoViNaT as well as positive and negative controls in the kit

RAPID

Gives positive result only in 58 minutes


ACCURATE

Detects 3 different genes It is not a subjective test

Covidigen plus logo

EASY TO USE

Simple to process, esay to interpret.


SENSITIVE

Presence of small amount of viruses are enough to detect

COVIDIGEN PLUS

Features

COVIDIGEN PLUS

Covidigen Plus Multiplex OneStep RT-PCR Kit is a Taqman-probe-based Real-time PCR test designed for the qualitative detection of a mutant corona virus variant VUI-202012/01 with SARS-CoV-2, the etiological agent of COVID-2019. The test is used in the detection of Orf1ab and S genes in viral RNA of the specified pathogens, respectively. As an internal control, the target gene is the RnaseP gene.

Coronaviruses are a large family of viruses that cause infections in humans and other mammals (such as camels, cats, dogs and bats). Sars-CoV-2 virus is a new coronavirus that was identified by the World Health Organization (WHO) on February 11, 2020. The SARS-CoV-2 RT-PCR Kit is an In-vitro diagnostic kit using original primers designed for the calibrative detection of the genomic RNA of the COVID-19 causative SARS-CoV-2 coronavirus. The Kit has been validated to be applied to nucleic acid extracts obtained by vNAT extraction buffer or robotic extraction systems from nasopharyngeal aspirate / lavage, bronchoalveolar lavage, nasopharyngeal swab, oropharyngeal swab and sputum samples. Considering the current international passenger network, specific virus detection in a short time is very important. Detection of this virus with that kit is possible in one step and in less than 40 minutes.

Content: England N501Y Mutation

Test used to detect the covid-19 virus mutation originating in England

  • Ref. Kit content 500 Tests

Necessary equipment and chemicals not supplied with kit

  • 1. Biological Cabinet
  • 2. Viral RNA Extraction Kit
  • 3. Real time PCR Device
  • 4. Real time PCR test tubes/strips/plates
  • 5. Adjustable Micropipettes (0.5μl – 1000μl)
  • 6. Micropipette Tips with Filter
  • 7. 1.5 ml Microcentrifuge Tube
  • 8. Cooler Working Block
  • 9. Powder-free disposable inspection glove
  • 10. Medical Waste Container
  • 11. Cooler Cabinets (+4/-20)
  • 12. Desktop centrifuge (Max 2,000 g)
  • 13. Vortex mixer

Content: Africa E484K Mutation

Test used to detect covid-19 virus mutations of African origin

  • Ref. Kit content 500 Tests

Necessary equipment and chemicals not supplied with kit

  • 1. Biological Cabinet
  • 2. Viral RNA Extraction Kit
  • 3. Real time PCR Device
  • 4. Real time PCR test tubes/strips/plates
  • 5. Adjustable Micropipettes (0.5μl – 1000μl)
  • 6. Micropipette Tips with Filter
  • 7. 1.5 ml Microcentrifuge Tube
  • 8. Cooler Working Block
  • 9. Powder-free disposable inspection glove
  • 10. Medical Waste Container
  • 11. Cooler Cabinets (+4/-20)
  • 12. Desktop centrifuge (Max 2,000 g)
  • 13. Vortex mixer
TESTS

How is it implemented?

Lower respiratory tract samples (bronchoalveolar lavage, sputum, tracheal aspirate) and upper respiratory tract samples (nasopharyngeal fluids and swabs) taken from individuals with swabs and / or saliva samples should be transported in tubes containing specially designed CoViNaT solution to the appropriate laboratory in proper conditions.

Samples taken from individuals who has the symptoms which are defined by WHO and the CDC (Center for Disease Control and Prevention-USA) for coronavirus disease 2019 (COVID-19) and/or Influenza A and B are directly tested in single-stage real-time reverse transcriptase polymerase chain reaction (Direct OneStep RT-PCR).

POZITIVE and NEGATIVE CONTROLS

The positive control sample included with the OneStep RT-PCR Kit is the fragment containing synthetically produced target gene regions (N/Orf1ab/RNaseP) and is extracted by manual method. As Negative Control, nuclease-free water (NFW) used in routine laboratory studies is used.


OneStep RT-PCR Reaction Mix

Seq. Nr. Prepare the following quantities in one tube respectively.
1 10 µl RT-qPCR 2X MasterMix
2 5 µl OligoMix
3 5 µl Total RNA
Final The final volume should be 20 μl.

Mastermix and oligomix mixtures are calculated 10% more than the number of samples and mixed in a sterile tube at a ratio of 2: 1. The mixture is homogenized by slowly turning it over and 15 µl is distributed to the wells for each sample. It is recommended to use a white strip or plate.


OneStep RT-PCR Device Setup

55°C to 10 min. 1 cycle Fluorescent Channels
95°C to 1 min. 1 cycle FAM (Green) Orf1ab
95°C to 5 min. 39 cycles HEX (Yellow) RnaseP
60°C to 20 sn (Fluorescent reading)

Evaluation of Reaction Results

Result Expected Ct Values Evaluations
FAM(Orf1ab) HEX*(RnaseP) Cy5 (S)
Negative Control Not detected Not detected Not detected Expected NC
Pozitive Control ≤38 Detected ≤38 Expected PC
1. ≤38 Detected / Not detected Not detected COVID-19 Pozitive
2. Not detected Not detected Not detected Test re-run
3. Not detected Detected Not detected COVID-19 Negatif
4. ≤38 Detected ≤38 VUI-202012/01 Pozitive
5. Not detected Not detected ≤38 Test re-run
6. ≤38 Detected 38 COVID-19 Pozitive, VUI-202012/01 Negative

*The average threshold value of the FAM and HEX channel is 100 RFU. The RFU value is not a constant value and may vary according to the viral load of the sample and the sigmoid structure of the chart.

VUI-202012/01 Pozitive


COVID-19 Pozitive, VUI-202012/01 Negative


WHO SHOULD BE TESTED?

It should be done to the individuals who have clinical symptoms defined for coronavirus disease 2019 (COVID-19) by WHO and CDC (Disease Control and Prevention Center-USA) and individuals who have influenza A and B symptoms whose symptoms are similar to Covid-19.

WHO SHOULD RUN THE TEST?

This test should be performed by trained personnel.

WHICH LABORATORY CAN RUN THE TEST?

  • The laboratory should be BSL2 class, the tests should be conducted according to the laboratory safety guidelines declared by WHO.
  • The tests to be applied for COVID-19 and Influenza A + B group viruses must be carried out by personnel who trained in the relevant technical and safety procedures in a properly equipped laboratory.
  • TEST EQUIPMENTS

    • Real-Time PCR devices compatible with the study of the test, specified as follows:
    • ABI Prism 7000/7300/7500/7900/Step One Plus
    • iCycler iQTM4/iQTM5
    • Smart Cycler II
    • Bio-Rad CFX 96
    • Rotor GeneTM6000
    • Mx3000P/3005P
    • MJ-Option2/ Chromo4
    • ®LightCycler 480 Instrument

    ISSUES TO BE CONSIDERED

    • Clinical samples should be considered as potentially infectious material and prepared in a laminar flow cabinet.
    • Each step should be implemented following GLP conditions.
    • Expired kits should not be used.
    • Repeated freezing / thawing may reduce the sensitivity of the kit.
    • For thawed reactive, briefly vortex and mini-spin should be done just before use.
    • The reaction mixture should be prepared quickly on ice or in a cooling block.
    • Two different workspaces should be created:
      1) RNA / DNA extraction area
      2) Amplification and Detection area
    • Pipette tips, tubes and other working materials belong to the one area and should not be used in different areas.
    • A sterile filter pipette tip should be used at all times.
    • Pipetting by mouth should not be done. Eating, drinking and smoking should not be done in the laboratory.
    • Aerosols should be avoided.

    LOGISTIC

    Transport

    COVIDIGEN PLUS KIT BOX

    • Covidigen Plus PCR test Kit box has 250 or 500 tests/kit
    • exp. Date: 12 months
    • Storage conditions: -15/-25°C
    • Dimensions (LxWxH): 90.5mm x 86.5mm x 50mm

    COVIDIGEN PLUS PHTRP2020-500

    • 18 Covidigen Plus PCR test Kit (for 500 tests 9.000 tests)
    • Total GW : 6.500 GR
    • Dimensions (LxWxH): 372mm x 372mm x 310mm

    Big package

    For CoViNaT:

    • Every package has 12 box (1200 pcs.)
    • GW: 13.900 GR

    For Swab:

    • Every package has 12 box (6000 pcs.)
    • GW :14.000 GR

    Box

    For CoViNaT: PH2020-100

    • Every box has 100 CoViNaT
    • Ex. Date for vtm: 12 months.
    • Storage conditions: +5/+25°C
    • Gamma irradiation

    For Swab: PH2020SWAB-500

    • Every box has 500 swab
    • Ex. Date For Swab: 24 months.
    • Storage conditions: +5/+25°C
    • Gamma irradiation