PCR kits for myCROBE®

fully automated sample to result solution

Choose from the following panels of PCR kits for myCROBE!

Immunocompromised /Transplanted Panel

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Immunocompromised / Transplanted Panel

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

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

LINK TO PRODUCTS IN THE GROUP AND ORDER INFORMATION

name of a product

GeneProof Cytomegalovirus (CMV) MC PCR Kit

GeneProof Epstein-Barr Virus (EBV) MC PCR Kit

GeneProof BK Virus (BKV) MC PCR Kit

GeneProof JC Virus (JCV) MC PCR Kit

GeneProof Human Herpesvirus 6/7 (HHV-6/7) MC PCR Kit

GeneProof Human Herpesvirus 8 (HHV-8) MC PCR Kit

GeneProof Herpes Simplex Virus (HSV-1/2) MC PCR Kit

GeneProof Varicella-Zoster Virus (VZV) MC PCR Kit

myCROBE/croBEE 2.0 Universal Extraction Kit

myCROBE Universal Internal Control

myCROBE Universal Control Set

myCROBE/croBEE 2.0 Tips

myCROBE PCR pack (PCR plate, PCR seal, Waste bin)

PART OF myCROBE SOLUTION

certified diagnostic tests

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Sexually Transmitted Infections

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Sexually Transmitted Infections Panel

Freely combinable PCR tests for myCROBE Fully Automated Instrument

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

LINK TO PRODUCTS IN THE GROUP AND ORDER INFORMATION

name of a product

GeneProof Chlamydia trachomatis MC PCR Kit

GeneProof Neisseria gonorrhoeae MC PCR Kit

GeneProof Mycoplasma hominis MC PCR Kit

GeneProof Mycoplasma genitalium MC PCR Kit

GeneProof Ureaplasma parvum MC PCR Kit

GeneProof Ureaplasma urealyticum PCR Kit

GeneProof Trichomonas vaginalis MC PCR

GeneProof Herpes Simplex Virus (HSV-1/2) MC PCR Kit

GeneProof Treponema pallidum MC PCR Kit

GeneProof Gardnerella vaginalis MC PCR Kit

myCROBE/croBEE 2.0 Universal Extraction Kit

myCROBE Universal Internal Control

myCROBE Universal Control Set

myCROBE/croBEE 2.0 Tips

myCROBE PCR pack (PCR plate, PCR seal, Waste bin)

PART OF myCROBE SOLUTION

certified diagnostic tests

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Thrombotic Mutations

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Thrombotic Mutations Panel

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

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

LINK TO PRODUCTS IN THE GROUP AND ORDER INFORMATION

name of a product

GeneProof Factor II Prothrombin MC PCR Kit

GeneProof Factor V Leiden MC PCR Kit

GeneProof Factor XIII V34L MC PCR Kit

GeneProof MTHFR C677T MC PCR Kit

GeneProof MTHFR A1298C MC PCR Kit

GeneProof PAI-1 Genotyping MC PCR Kit

myCROBE/croBEE 2.0 Universal Extraction Kit

myCROBE Genetic Control Set

myCROBE / croBEE 2.0 Blood Pretreatment Sample tube

myCROBE/croBEE 2.0 Tips

myCROBE PCR pack (PCR plate, PCR seal, Waste bin)

PART OF myCROBE SOLUTION

certified diagnostic tests

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COVID-19 Solution

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COVID-19 Solution

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

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