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Exclusivity / Analytical Specificity
To exclude cross-reactivity (exclusivity), an in silico analysis (BLAST align-
ment) of the target region of C. auris against the genomic sequence of
various other pathogens representing common commensal microorganisms
or closely related species was conducted. There was no evidence of an inter-
ference for the detection system of C. auris (Table 3).
Reproducibilty
The reproducibility of the Vivalytic C. auris test was established using a pan-
el with 3 different concentrations of Candida auris. At 3 test sites, each mix
was tested on the same set of Vivalytic instruments by the same operator
with 3 LOTs in 4 replicates on 3 days, respectively. The obtained positivity
rates for the different combinations were correlated to the expected positiv-
ity rate (Table 4a).
Repeatability
The repeatability of the Vivalytic C. auris test was established using a panel
with 1 concentration (3x c95) of Candida auris. At 1 test site, the mix was
tested on the same set of Vivalytic instruments by the same operator with
3 LOTs in 20 replicates, respectively, yielding a total of 60 observations per
target pathogen. The obtained positivity rates for the different combinations
were correlated to the expected positivity rate (Table 4b).
Interferences
Interferences were evaluated for endogenous and exogenous substances
that are potentially present in the patient sample. Refer to Table 5 for sub-
stances that have the potential to interfere with the test.
Clinical Performance evaluation Sensitivity and Specificity
In total, 231 samples with valid results were tested (126 clinical samples,
50 spiked samples and 55 isolates) at two study sites. All samples were
prepared according to recommendations of used methods. Sensitivity or
Positive Percent Agreement (PPA) was calculated as 100 % x TP/ (TP+FN).
Specificity or Negative Percent Agreement was calculated as 100 % x TN /
(TN+FP). The results of the clinical performance evaluation are shown in
Table 6a and Table 6b.
Technical Support
If you require any support, technical help or have additional questions,
please contact your local distributor or visit the Bosch Vivalytic website at
www.bosch-vivalytic.com.
References
Fernandes L, Ribeiro R, Henriques M, Rodrigues ME. Candida auris,
1
a singular emergent pathogenic yeast: Its resistance and," Eur J Clin
Microbiol Infect Dis, Nr. 12, pp. 1371-1385, 2022;12;1361-1385;
Preda M, Chivu RD, Ditu LM, Popescu O, Manolescu LSC. Pathogenesis,
2
Prophylaxis and Treatment of Candida auris. Biomedicines.
2024;12(3):561. doi: 10.3390/biomedicines12030561.
Cristina ML, Spagnolo AM, Sartini M, Carbone A, Oliva M, Schinca E, Boni
3
S, Pontali E. An Overview on Candida auris in Healthcare Settings. J Fungi
(Basel). 2023 Sep 8;9(9):913. doi: 10.3390/jof9090913
Centers for Disease Control. https://www.cdc.gov/candida-auris/
4
COPAN Liquid Amies Elution Swab (ESwab®) Collection and Preservation
5
System Instructions for use; Version HPC031R08 Date 2021.10
Vivalytic C. auris
– Instructions for use
6
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