Abbott RealTime CT/NG

Abbott RealTime
CT/NG
New
Formulation with
Dual Targets
Abbott RealTime CT/NG
The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay
for the direct, qualitative detection of the plasmid DNA for Chlamydia trachomatis and
the genomic DNA of Neisseria gonorrhoeae in female endocervical or vaginal swab
specimens, male urethral swab specimens, or male and female urine specimens.
The Abbott RealTime CT/NG assay uses PCR technology with homogenous real-time
fluorescence detection. The CT/NG assay is used for the dual detection of the sexually
transmitted disease pathogens, C. trachomatis and N. gonorrhoeae.
Abbott RealTime CT/NG Performance
Technology
Sensitivity
Specificity
Serovar Detection
Interference
Target Region
Specimen
Internal Control
Collection Device
Multiplex, homogenous RealTime PCR
320 plasmid copies per 400 µl sample
No cross-reactivity with 111 organisms
All C. trachomatis serovars and all N. gonorrhoeae strains were detectable
No interference with 26 substances
C. trachomatis: Dual Targets in cryptic plasmid
N. gonorrhoeae: Opa gene
Endocervical, vaginal and urethral swabs; male and female urine
Added to lysis buffer during extraction
Measured to demonstrate proper specimen processing and assay validity
Abbott multi-Collect Specimen Collection Kit
Dual Cryptic Plasmid Targets
377bp deletion (nvCT)
Abbott RealTime CT
target region
CT cryptic plasmid X06707
7501 bp
Benefits
Abbott RealTime CT
additional target region
Detects wtCT clinical specimen
Detects nvCT clinical specimen
High sensitivity of cryptic plasmid
Built in back-up potential for new strains

Analytical Sensitivity
Analytical sensitivity of the CT/NG assay was evaluated. A CT sample and a Swedish variant CT (nvCT)
sample were prepared to the LOD of the assay, 320 plasmid copies per 400 µl of specimen transport
buffer, and tested with three lots of amplification reagents on three m2000 Systems. The results are
summarized and demonstrate the representative sensitivity of both CT and NG assay components.
One-sided Lower
Replicates Tested Replicates Detected Detection Bound of
Analyte n n Rate (%) 95% CI (%)
CT 403 403 100.0 99.3
nvCT 403 403 100.0 99.3
NG 403 403 100.0 99.3
Performance data shown from internal verification.
Analytical Specificity (Cross Reactivity)
A total of 111 strains of bacteria, viruses, parasites, yeast, and fungi that can be found in the urogenital
tract were tested for potential cross reactivity in the Abbott RealTime CT/NG assay. Three replicates of
each purified DNA, RNA, or purified viral particles were diluted in transport buffer to final concentrations
of 1x10 7 copies per 0.4 ml sample preparation input for the m2000sp CT/NG sample preparation. All
results were negative for both CT and NG.
High-Low Concentration Challenge Study
A study was performed to evaluate the performance of the Abbott RealTime CT/NG assay when samples
contained high target numbers of either CT or NG in the presence of low target numbers of the opposite
analyte. One sample (T1) was prepared to contain wtCT at 320 plasmid copies and NG at 1x10 7 plasmid
copies per 0.4 ml. A second sample (T2) to contain wtCT at 1x10 7 plasmid copies and NG at 320 plasmid
copies per 0.4 ml. A third sample (T3) was prepared to contain Swedish cryptic plasmid deletion variant
of CT (nvCT) at 320 plasmid copies and NG at 1x10 7 plasmid copies per 0.4 ml and a fourth sample
(T4) to contain nvCT at 1x10 7 plasmid copies and NG at 320 plasmid copies per 0.4 ml. The four samples
were tested with three lots of reagents on three m2000 Systems for a total of 405 replicates.
One-sided Lower
Replicates Replicates Detection Bound of
Analyte Sample n Detected Rate (%) 95% CI (%)
CT T1 400 a 397 99.3 98.1
NG T2 404 b 398 98.5 97.1
CT T3 405 405 100.0 99.3
NG T4 405 405 100.0 99.3
a
Five replicate results were invalid and excluded from analysis. b One replicate result was invalid and excluded from analysis.
Product List Number Configuration
Abbott RealTime CT/NG Amplification Reagent Kit 2G2891 192 tests (4 packs of 48 tests/pack)
Abbott RealTime CT/NG Control Kit 2G2880 8 CT/NG Negative Control,
16 CT/NG Cutoff Control
Abbott RealTime CT/NG Application CD-ROM 1L7004 1 each
Abbott multi-Collect Specimen Collection Kit 9K1201 500 per case (10 boxes with 50/box)
Abbott mSample Preparation System DNA 6K1224 192 (4 x 48 preparations)
All data from Instructions for Use
AR2140/uk Abbott RealTime CT/NG 01/08/17