AurisID


The only validated test for Candida auris screening on surveillance swabs, without DNA extraction

AurisID is a CE IVD-labelled Real-Time PCR test for the identification of Candida auris from:

  • surveillance swabs (axillary/ inguinal)
  • serum
  • plasma

It is currently the only validated test for screening on surveillance swabs, without the need for a nucleic acid extraction step, with an analytical sensitivity of up to 1 genome copy/reaction.

AurisID screens a variable number of swabs (1 to 94), simultaneously, in less than 1 hour.

The ability to process different biological matrices offers a greater range of applicability. AurisID can in fact be used:
1) for sepsis identification (from serum and plasma);
2) for surveillance programmes on the spread of Candida auris in the nosocomial environment (from surveillance swabs);
3) for screening of direct contacts of positive subjects as indicated by the Ministry of Health (from surveillance swab)

The ease of execution and the rapidity with which the result is provided guarantee the possibility of immediate management of the patient in case of positivity, reducing the risk of yeast spread.

The system is validated on the most common Real-Time PCR instruments available in laboratories.

The test demonstrates sensitivity, specificity, NPV and PPV of 96.6%, 100%, 98.2% and 100% respectively, values highlighted in the article Bayona et al., 2021 ‘Validation and implementation of a commercial real-time PCR assay for direct detection of Candida auris from surveillance samples’.

  • Sensitivity <1 genome of Candida auris
  • Detection in a range of 6 orders of magnitude (target number <1 to 10^6)
  • Result in <1h without DNA extraction
Candida auris

Are you ready for a case of Candida auris?

Click on questions to get answers

Candida auris, a species of the genus Candida, is a globally emerging multi-resistant pathogen causing nosocomial infections. Since it was first isolated, C. auris has been associated with bloodstream and wound infections and has caused hospital outbreaks in several countries. C. auris is commonly resistant to the first-line antifungal drug fluconazole and multi-resistant strains have been reported.

Because the spread of resistant strains of the Candida auris fungus continues to affect an ever-increasing number of Italian regions.
And also because the fungus, as issued by the Ministry of Health: ‘is resistant to commonly used antifungal treatments, including azoles, echinocandins and polyenes, and to the usual antifungal products for cleaning surfaces’. In fact, the fungus forms a biofilm that makes it not very susceptible to disinfectants, so it is particularly resistant on surfaces.

The MSAL states that ‘it is difficult to diagnose Candida auris using standard laboratory methods, which easily lead to misidentification and subsequent inappropriate case management of infection or colonisation’ and on 19 June 2023 issued very precise guidelines for the management of Candida auris surveillance.

Go to MSAL Circular

“The number of Candida auris infection/colonisation cases continues to increase rapidly in many countries. […] In Italy, during the period 1 July 2019 – 22 December 2022, 361 cases of infection/colonisation (median age about 64 years, range 0-91, mainly males) were notified to the undersigned Ministry from 17 healthcare facilities in four regions (Liguria 82%, Piedmont 13%, Emilia-Romagna 4%, Veneto 1 case), of which at least 146 (40%) died. More than 90% of the cases were colonised, at least half had comorbidities and at least one third were SARS-CoV-2 positive. In the same period, further cases of infection/colonisation (at least 206 cases) were not reported. Subsequently, more cases (around 40) were notified, also involving two regions that had not notified cases previously (Liguria, Piedmont, Lazio, Tuscany). There is, therefore, an increasing risk of intra-hospital transmission, of the possible development of candidemia, especially in the case of multiple simultaneous colonisation, and of community spread.

“[…] Therefore, individuals who have shared a room with an infected/colonised patient should be identified and screened even if they have been discharged from the facility.

“[…] In critical wards where cases continue to occur, it is important to consider screening for healthcare personnel working there, e.g. by culture of handprint on agar plate, in addition to routine and non-routine environmental sanitation procedures.

“[…] Screening for C. auris on admission is indicated in individuals with a history of hospital stay (of at least one night) or rehabilitation activities, in the previous 12 months, in care facilities located in the most affected regions.”

GO TO THE CIRCULAR OF THE MINISTRY OF HEALTH

Both tests, when used correctly, allow the identification of Candida auris. Compared to a culture test, the result of which is obtained after ~48 h, the molecular test is much faster.

Real-Time PCR is a rapid, sensitive and specific method that enables a large number of samples to be processed in a short time.
AurisID is a UNIQUE kit on the market. Here’s why.
It is the fastest and most processable: it processes from 1 to 94 swabs in 50 minutes;
it has the best performance: sensitivity, specificity, PPV, NPV ~ 100%;
it is the only one from surveillance swabs (Copan) that does not require DNA extraction, validated and CE-IVD-marked.
Given its high rapidity, AurisID makes it possible to promptly implement all measures to isolate the colonised patient and to contain the spread of the fungus.

The kit is compatible with eSwab Copan swabs: the transport liquid of the swab is directly loaded into the reaction mix, without the need for an extraction step. This increases the processivity of the test by reducing the set-up time of the analytical run. The kit is compatible with the most common Real-Time instruments. This allows you to take advantage of existing resources in your laboratory. In case these are not available, LionDx can provide in-service instruments.

AurisID is an ‘open’ kit in that it can be used on the most common instruments found in laboratories. Here are just a few of them.

EXTRACTION: Qiagen EZ1, QiaSymphony, Qiagen QIAamp spin columns, Qiagen QiaCube, Roche MagnaPure and others.

AMPLIFICATION: ABI 7500, Qiagen RotorGene, BioRad CFX96, Illumina Eco, BMS MIC, Roche LC480 (II) and others, Agilent AriaMx and others.

The protocol is based on 40 cycles of amplification, within which up to <1 copy/reaction can be detected. The kit has a clinically proven specificity of 100%, so if there is amplification within 40 cycles the test should be interpreted as positive.

By using the swab, the AurisID kit can help detect fungal DNA even from surfaces.

AurisID is a highly innovative kit UNIQUE on the market. So simply ask LionDx for the “certificate of uniqueness” and proceed quickly with “direct negotiation”.
In case your facility does not have an instrument suitable for performing Real-Time PCR, LionDx will be happy to provide one as a service.

LionDx, a company specialising in fungal diagnostics, makes its know-how available should your facility need it. In addition, through its specialists, it offers on-site demos as well as a ‘direct line’ to its customers for any needs.

Surveillance is the best form of prevention. As colonisation by Candida auris is totally asymptomatic and contagion occurs by contact, screening of all patients to be admitted to high-risk wards (such as intensive care) is necessary to avoid outbreaks. If a patient is found to be positive, it would be necessary to screen all persons who came into contact with the colonised patient as well as potentially contaminated hospital surfaces (see point 1).
AurisID is the perfect kit for surveillance: it has 50 tests that can be used individually. The current batch expires at the end of January 2025.

AurisID is the perfect kit for surveillance: it has 50 tests that can be used individually. The current batch expires at the end of January 2025.
So if you buy it today, you have almost 2 years to perform 50 tests!
Obtaining at least one AurisID kit means taking out a policy against Candida auris.

LionDx is willing to organise training sessions at your facility in order to make the link between the clinical and diagnostic departments more effective.

The Journal of Fungi, published the paper ‘Validation and implementation of a commercial real-time PCR assay for direct detection of Candida auris from surveillance samples’.

The authors are: Juan V. Mulet Bayona, Carme Salvador García, Nuria Tormo Palop, Concepción Gimeno Cardona

Whose conclusions we report:

Our PCR method using the AurisID® kit allows a reduction in the turnaround time for surveillance of C. auris compared with other methods. These results are expected to contribute to control C. auris outbreaks, allowing isolation of patients and cleaning of environmental surfaces in advance.

STUDY

AurisID can be purchased via direct negotiation on MEPA, by submitting an application to the administration office of your organisation. The kit is unique on the market and is accompanied by a declaration of uniqueness. LionDx is at your disposal to formulate the best offer and support you in the application and purchase process.

“The number of Candida auris infection/colonisation cases continues to increase rapidly in many countries. […] In Italy, during the period 1 July 2019 – 22 December 2022, 361 cases of infection/colonisation (median age about 64 years, range 0-91, mainly males) were notified to the undersigned Ministry from 17 healthcare facilities in four regions (Liguria 82%, Piedmont 13%, Emilia-Romagna 4%, Veneto 1 case), of which at least 146 (40%) died. More than 90% of the cases were colonised, at least half had comorbidities and at least one third were SARS-CoV-2 positive. In the same period, further cases of infection/colonisation (at least 206 cases) were not reported. Subsequently, more cases (around 40) were notified, also involving two regions that had not notified cases previously (Liguria, Piedmont, Lazio, Tuscany). There is therefore an increasing risk of intra-hospital transmission, of the possible development of candidaemia, especially in the case of multiple simultaneous colonisation, and of community spread.

[…] Therefore, individuals who have shared a room with an infected/colonised patient should be identified and screened even if they have been discharged from the facility.

[…] In critical wards where cases continue to occur, it is important to consider screening for healthcare personnel working there, e.g. by agarised handprint plate culture, in addition to routine and non-routine environmental sanitisation procedures.

[…] Screening for C. auris on admission is indicated in individuals with a history of hospital stay (of at least one night) or rehabilitation activities, in the previous 12 months, in care facilities located in the most affected regions.”