NG-Test CTX-M MULTI
Rapid
Rapid, mobile, connected diagnostics
www.ngbiotech.com
• Results in 15 minutes• From bacterial culture• Minimal hands on time
User friendly• Minimal training needs• No equipment needed• No maintenance costs• Stable at room temperature
Detection of CTX-M-Type Extensed Spectrum β-lactamasesgroups 1, 2, 8, 9 & 25
min15
Accurate• Excellent correlation with PCR• Evaluations available
CTX-M M
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MADE IN
F R A N C E
Rapid, mobile, connected diagnostics
NG-Test CTX-M MULTI Culture Casse�e 4-30°C 24 months NGB-CTM-S23-00220 tests
Cat. Ref.Product Specimen Format Packaging Storage Shelf-life
NG-Test CTX-M MULTI
Performance Characteris�cs
NG-Test CTX-M MULTI detects the following variants:Group 1: CTX-M-1, -3, -10, -15, -32, -37, -55, -57, -71, -82, -101, -182Group 2: CTX-M-2Group 8: CTX-M-8Group 9: CTX-M-9, -13, -14, -17, -18, -19, -24, -27, -65, -93Group 25: CTX-M-94, -100
Detec�on limitThe detec�on limit was determined using purified recombi-nant enzymes.Group 1 / CTX-M-15 250 pg/mLGroup 2 / CTX-M-2 600 pg/mLGroup 9 / CTX-M-14 100 pg/mL
REV 18 10 10
These tests were developed in collabora�on with the CEA*.*The French Alterna�ve Energies and Atomic Energy Commission (CEA) is a key player in research, development and innova�on.
Opera�ng procedure
culturecolonies
21
5 drops
Bu�er
3 4
100 µL
5
100 µL
S
min15
Z.A. Courbouton, secteur 1 - 35480 Guipry, FrancePhone: +33 (0)2 23 30 17 83 Fax +33 (0)9 71 70 53 10 [email protected]
For professional in vitro diagnostic use only
IDENTIFICATION PROCESS FROM BACTERIAL CULTURE
Stool / Urine / Blood culture /Biological samples
Selec�ve medium* 18-24H
NG-Test CTX-M MULTI
*Validated on: TSA, Mueller Hinton, ChromID® CARBA SMART, Drigalski (DRIG) CHROMagarTM mSuperCARBATM…etc
Day 0 Day 1
15 min
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NG Biotech
CTX-M M
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Interpreta�on
Negative Positive Invalid Invalid
Sensi�vity : 100% 95% confidence interval : 97,5% to 100%Specificity : 100% 95% confidence interval : 80,6% to 100%
Valida�on on a reference strain bankNG-Test CTX-M MULTI was evaluated on 165 isolates (PCR characterized ESBL content) at the NRC (AMR French Na�onal Reference Centre) of CHU Kremlin Bicêtre Paris-France.
Posi�ve result 149 0 149Nega�ve result 0 16 16
Total 149 16 165
NG-TestStatus
Posi�veNG-Test
CTX-M MULTI
Nega�veNG-Test
CTX-M MULTITotal
CTX-M M
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