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Development and Performance of the CE-marked QIAGEN® artus ® GBS QS-RGQ Kit

Gavin Wall1, Vishi Srinivasan2, Heinz Reiske2, Bill Lauzier2, Brian Bishop2, Renda Hawwa2 and Maurice Exner2
1
QIAGEN GmbH, QIAGEN Strasse 1, 40724 Hilden, Germany; 2
IntelligentMDx (IMDx), 285 Bear Hill Road, Waltham, MA, USA

Introduction Methods Results: Limit of Detection (LOD)


Infection with Group B streptococcus (GBS) remains a leading cause of severe neonatal disease worldwide and is The artus GBS QS-RGQ Kit is a qualitative, multiplexed, real-time PCR-based IVD assay to detect GBS directly from Lim broth The limit of detection of the artus GBS QS-RGQ Kit is 74.07 CFU/ml for GBS serotype Ia and 24.29 CFU/ml for serotype III.
responsiblefor most cases of neonatal sepsis, posing a significant threat to newborn health. When a universal antenatal cultures obtained by incubating vaginal/rectal swab specimens from antepartum women, using the QIAsymphony SP/AS ®

GBS screening-based strategy is used to identify women who are given antimicrobial prophylaxis, a substantial reduction and Rotor–Gene® Q instruments.
in incidence up to 80% has been reported in many countries. However, recommendations are still a matter of debate Studies evaluated the analytical and clinical performance characteristics of the artus GBS QS-RGQ Kit. To assess the
due to challenges and controversies on how best to identify candidates for prophylaxis and the drawbacks of intrapartum performance characteristics of the artus GBS QS-RGQ Kit, a series of validation studies were conducted.
administration of antibiotics (1, 2).
• Analytical reactivity was assessed by testing 21 GBS strains representing serotypes Ia, Ib, II, III, IV, V, VI, VII, and VIII.% Detected % Detected % Detected % Detected

100 100 100 100


GBS-colonized mothers are the primary risk factor for disease, as they can transmit the bacteria to newborns in utero or
• Limit of detection studies were conducted for serotype Ia and III using Lim broth, plus matrix. LoD: 74.07 LoD: 74.07 LoD: 24.29 LoD: 24.29
vaginally during birth. In Europe, GBS vaginal colonization rates have been reported to range from 6.5 to 36%, with 95% CI: (40.29–181.0695%
CFU/ml)
CI: (40.29–181.06 CFU/ml) 95% CI: (16.73–64.57 CFU/ml)
95% CI: (16.73–64.57 CFU/ml)

• The assay was tested for potential interference and cross-reactivity using a panel of organisms found in genital and rectal 80 80 80 80

serotypes Ia, II and III being the most frequently identified. European guidelines suggest that all pregnant women should
specimens and a panel of potentially interfering substances that may be used on or near the sampling site.
be screened between 35–37 weeks gestation for GBS vaginal and rectal colonization and antibiotics administered at the 60 60 60 60

time of delivery to women that are identified as GBS-positive. • The clinical performance of the artus GBS QS-RGQ Kit was evaluated using clinical samples from 4 geographically
diverse locations in the United States using enriched culture and bi-directional sequencing as the reference method. 40 40 40 40

20 20 20 20

0 0 0 0
0.001 0.01 0.001 0.1 0.01 1 0.1 10 1 100 10 1000 100 1000 0.1 0.1 1 1 10 10 100 100

GBS serotype Ia log CFU/ml


GBS serotype Ia log CFU/ml GBS serotype III log CFU/ml
GBS serotype III log CFU/ml

Limit of detection of the artus GBS QS-RGQ Kit. Probit analysis of serotype Ia and serotype III.

Streptococci.

Results: Analytical Reactivity and Assay Interference Results: Clinical Study Agreement Conclusions
The analytical reactivity of the artus GBS QS-RGQ Kit was assessed to determine whether the kit could detect an array of In the clinical studies, a total of 369 Lim broth cultures were evaluated and results from the artus GBS QS-RGQ Kit were • The artus GBS QS-RGQ Kit demonstrated effective
GBS serotypes and clinical isolates. A total of 21 GBS isolates representing various serotypes were diluted in Lim broth compared to results obtained from reference culture and bi-directional sequencing. With the clinical samples tested, the analytical performance with excellent correlation to
plus matrix to approximately 2–3x LoD and tested with the artus GBS QS-RGQ Kit. GBS target was detected in all strains artus GBS QS-RGQ Kit showed an overall diagnostic sensitivity of 95% (with a positive predictive value of 87%) and results obtained from reference culture methods.
tested. specificity of 95% (with a negative predictive value of 98%) for GBS in comparison with enriched culture and bi-directional • Combined with a turnaround time of one work shift
No interference or cross-reactivity was found when the assay was challenged with a panel of 59 organisms (bacteria, sequencing. for up to 70 patient samples, this assay is a desirable
viruses and fungi) and a panel of 34 substances (including those commonly found in indigestion remedies/antacids, option for screening antepartum women at risk for GBS
laxatives, hemorrhoid gel and other topical creams). None of the substances showed an inhibitory effect on the signals of colonization.
the internal control and GBS. GBS clinical agreement study results.
The artus GBS QS-RGQ Kit was CE-marked in June 2014.
Culture + bi-directional sequencing

+ – Total
artus GBS QS-RGQ Kit.
+ 90 13 103
artus GBS
– 5 261 266 Reference
QS-RGQ Kit
Total 95 274 369 1. Di Renzo, G.C., Melin, P., Berardi, A., et al. (2014) Intrapartum GBS screening and antibiotic prophylaxis: a European consensus conference. J. Matern.
Fetal Neonatal Med. 27, 1.
2. Verani, J.R., McGee, L., Schrag, S.J., et al. (2010) Prevention of perinatal group B streptococcal disease – revised guidelines from CDC 2010. MMWR
Recomm. Rep. 59(RR-10),1.
95% CI

Sensitivity 95% 88–98%


For up-to-date licensing information and product-specific disclaimers, see the respective QIAGEN kit handbook or user
Specificity 95% 92–97%
manual. QIAGEN kit handbooks and user manuals are available at www.qiagen.com or can be requested from QIAGEN
Positive predictive value 87% 80–92%
Technical Services or your local distributor.
04/2015

Negative predictive value 98% 96–99%


Prevalence 26% 22–30%
Agreement 95% N/A Trademarks: QIAGEN®, QIAsymphony®, artus ®, Rotor-Gene® (QIAGEN Group). Registered names, trademarks, etc. used in this document, even when not
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specifically marked as such, are not to be considered unprotected by law. © 2015 QIAGEN, all rights reserved.

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