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PCR kits for myCROBE®

fully automated sample to result solution

Choose from the following panels of PCR kits for myCROBE!

Immunocompromised / Transplanted Panel

A complete portfolio of PCR tests for automated diagnostics using myCROBE Fully Automated Instrument

JCV

Complete precise diagnostics with simple workflow

WIDE RANGE OF TESTS

  • Detection of CMV, EBV, BKV, JCV, HHV-6, HHV-7, HHV-8, HSV-1, HSV-2, VZV

EXACT AND REPEATABLE QUANTIFICATION

  • Full traceability to WHO standards
  • Automatic evaluation of quantitative results

SIMPLE LABORATORY WORKFLOW

  • Full automation reduces staff and organizational requirements
  • Suitable also for staff with less experience with PCR testing

myFLEX CONCEPT

  • Extensive flexibility
  • Multiple specimen types and tests in a single run 
  • Any combination of tests from one sample and up to 10 different tests per sample
GROUP INFORMATION
Indication in vitro diagnostic medical devices
Regulatory Status CE IVD
Intended User For professional use in laboratories with trained staff
Test Principle Real-time PCR
Automated / Manual detection Automated
Extraction / Inhibition Control Internal Control by myCROBE Universal Internal Control
Validated Extraction Method myCROBE/croBEE 2.0 Universal Extraction Kit
Instrument myCROBE Fully Automated Instrument
PART OF myCROBE SOLUTION
CE 1023 IVD
certified diagnostic tests

Sexually Transmitted Infections Panel

Freely combinable PCR tests for myCROBE Fully Automated Instrument

TV

Complete portfolio of tests for differential diagnostics or screening

WIDE RANGE OF TESTS

  • Detection of CT, NG, MH, MG, UP, UU, TV, HSV-1, HSV-2, TP, GV

SCREENING CAPACITY

  • Suitable for CT/NG screening
  • Capacity of 108 samples in 8 hours

SIMPLIFYING DIAGNOSTICS

  • Differential diagnostics of infections with similar symptoms
  • Full automation of laboratory workflow reduces staff and organizational requirements
  • Automatic evaluation of results

myFLEX CONCEPT

  • Extensive flexibility
  • Multiple specimen types and tests in a single run 
  • Any combination of tests from one sample and up to 10 different tests per sample
  • Up to 11 different tests per sample
GROUP INFORMATION
Indication in vitro diagnostic medical devices
Regulatory Status CE IVD
Intended User For professional use in laboratories with trained staff
Test Principle Real-time PCR
Automated / Manual detection Automated
Extraction / Inhibition Control Internal Control by myCROBE Universal Internal Control
Validated Extraction Method myCROBE/croBEE 2.0 Universal Extraction Kit
Instrument myCROBE Fully Automated Instrument
PART OF myCROBE SOLUTION
CE 1023 IVD
certified diagnostic tests

Thrombotic Mutations Panel

PCR tests of the most prevalent thrombotic mutations for myCROBE Fully Automated Instrument

factor II

Unique automation of genetic diagnostics

SIMPLE LABORATORY WORKFLOW

  • Full automation reduces staff and organizational requirements
  • Suitable also for staff with less experience with PCR testing

myFLEX CONCEPT

  • Extensive flexibility
  • Any combination of tests from one sample and up to 6 different tests per sample

ARCHIVING OF EXTRACTED DNA

  • Extracted DNA can be archived for subsequent analysis
GROUP INFORMATION
Indication in vitro diagnostic medical devices
Regulatory Status CE IVD
Intended User For professional use in laboratories with trained staff
Test Principle Real-time PCR
Automated / Manual detection Automated
Validated Extraction Method myCROBE/croBEE 2.0 Universal Extraction Kit
Instrument myCROBE Fully Automated Instrument
PART OF myCROBE SOLUTION
CE 1023 IVD
certified diagnostic tests

COVID-19 Solution

Increase of a testing capacity of the laboratory using myCROBE Fully Automated Instrument

COV2S_shutterstock_1643947495

Reliable fully automated SARS-CoV-2 detection

W.H.O. RECOMMENDED DESIGN

  • Three targets (RdRp/E/N genes) in one reaction 
  • Reliable detection of all viruses variants 
  • Triple protection against detection failures caused by virus mutations

SIMPLE LABORATORY WORKFLOW

  • Full automation reduces staff and organizational requirements
  • Suitable also for staff with less experience with PCR testing
GROUP INFORMATION  
Indication in vitro diagnostic medical devices
Regulatory Status CE IVD
Intended User For professional use in laboratories with trained staff
Test Principle Real-time PCR
Function Diagnostics, aid to diagnosis and screening
What is detected / Target SARS-CoV-2
Automated / Manual detection Automated
Type of Analysis Qualitative
Validated Specimen Swab, transport medium
Targer Sequence RdRp, N and E genes
Analytical Specificity SARS-CoV-2, 100%
Analytical Sensitivity 138,33 cp/ml (transport medium: PBS)
Extraction / Inhibition Control Internal Control by myCROBE Universal Internal Control
Validated Extraction Method myCROBE/croBEE 2.0 Universal Extraction Kit
Instrument myCROBE Fully Automated Instrument
External Quality Assessment Tested in QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com
PART OF myCROBE SOLUTION
CE 1023 IVD
certified diagnostic tests

Documentation

Declaration of Conformity

MC_ MC100_Declaration of conformity_EN
pdf, [594 kB]

Product Leaflet

GP_Leaflet_myCROBE_EN
pdf, [2.95 MB]
GP_MC_PCR_kits_COVID_Solution
pdf, [398.71 kB]
GP_MC_PCR_kits_IT_panel
pdf, [238.72 kB]
GP_MC_PCR_kits_Thrombotic_mutations
pdf, [166.53 kB]

Manual

MC_MC100_Manual_EN
pdf, [924.85 kB]
Files are available only for registered users.

Videos

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