BOSCH Vivalytic Norovirus RT-PCR Test for Norovirus Instruction Manual

: July 5, 2024
: Bosch

Table of Contents

BOSCH Vivalytic Norovirus RT-PCR Test for Norovirus
Product Information
Product Usage Instructions
FAQs
Introduction
Package Contents
Intended Use
Safety Information
Storage and Usage Conditions
Sample Preparation
Analytical Performance Evaluation
Symbols
CONTACT
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

BOSCH Vivalytic Norovirus RT-PCR Test for Norovirus

Product Information

Specifications
- Product Name: Norovirus RT-PCR Test
- Pathogen List: Norovirus genogroup I/II
- Test Principle: Qualitative real-time RT-PCR

Product Usage Instructions

Warnings and Precautions
- Always follow good laboratory practices to ensure the proper performance of the test. Handle potentially infectious patient samples with standard precautions. Be compliant with national safety regulations and practices.
- Do not wait longer than 15 minutes after opening the cartridge pouch to begin the test. Prolonged exposure to humidity can negatively impact test performance. Maintain hygiene and avoid performance loss due to humidity.
Testing Procedure
- Open the cartridge pouch and prepare the test setup.
- Ensure the sample collection is done correctly according to the provided guidelines.
- Follow the instructions for loading the sample into the test cartridge.
- Insert the cartridge into the testing device.
- Start the test following the device’s operating instructions.
- Read and interpret the results based on the test outcome.
Maintenance and Storage
- Store the test kit in a cool, dry place as per the storage instructions provided in the product manual. Ensure that the kit is not exposed to extreme temperatures or direct sunlight.

FAQs

Q: What should I do if the test results are inconclusive?
- A: In case of inconclusive results, repeat the test using a new sample following the proper testing procedure.
Q: How often should I calibrate the testing device?
- A: Follow the manufacturer’s recommendations for device calibration, typically done at regular intervals or when indicated by the device.

Introduction

Norovirus belongs to the virus class Caliciviridae and is known to be a seasonal disease. It is a highly contagious pathogen that is responsible for the majority of cases of acute gastroenteritis worldwide. Norovirus infections in humans are mainly caused by genogroup II and I, while GII is the predominant cause of Norovirus outbreaks. Infections of the gastrointestinal tract by Norovirus are characterized by sudden onset symptoms such as nausea, vomiting, diarrhea, and abdominal pain. The virus is particularly prevalent in communal settings such as hospitals, schools, and nursing homes, where it can easily spread from person to person. The illness typically lasts only a few days but can cause more severe complications in immunocompromised individuals or the elderly. Acute gastroenteritis caused by Norovirus is a self-limiting disease although if untreated can cause a critical course of disease, especially in the youngest or elderly.1,2,3,4

Package Contents

15 Vivalytic Norovirus test cartridges for the detection of human Norovirus genogroup I/ II.

Pathogen List

Norovirus genogroup I/II

Intended Use

The Vivalytic Norovirus test is an automated qualitative in vitro diagnostic test based on real-time polymerase chain reaction (PCR) for the detection of nucleic acids from human Norovirus genogroup I/ II from liquid or soft human stool swabs to aid in the diagnosis of acute gastrointestinal infections of symptomatic individuals.
Results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not exclude co-infection with other pathogens.
The agent(s) detected may not be the definite cause of the disease.
Negative results do not exclude a Norovirus infection or another gastrointestinal infection. Results must be clinically correlated with patient history, clinical observations, and epidemiological information.
Other diagnostic information is necessary to determine the patient’s infection status.
Intended for use with a Vivalytic one analyzer by healthcare professionals only in laboratory settings such as hospital laboratories and reference laboratories.

Safety Information

These Instructions for Use contain test-specific information only. For additional warnings and instructions refer to the Instructions for Use provided with your Vivalytic One analyzer (chapter device safety information).
Only use Vivalytic cartridges and accessories approved for the Vivalytic One analyzer.
Take care to avoid any contamination when handling patient samples and cartridges.
When a sample is spilled on the cartridge, do not use the cartridge, and dispose of it.
For in vitro diagnostic use by trained healthcare professionals.

WARNING

Always follow good laboratory practice to ensure the proper performance of this test.
Make sure to wear appropriate personal protective equipment (PPE). Do not use a cartridge if the sealed pouch or the cartridge itself is visibly damaged.
Do not touch or scratch the detection area of the cartridge. Do not reuse a cartridge.
Do not use expired cartridges. The expiration date can be found on the packaging and the cartridge label.
Do not wait longer than 15 minutes after opening the cartridge pouch to begin the test. This maintains hygiene and avoids performance loss due to humidity. Prolonged exposure to humidity hurts test performance.
Do not shake a cartridge that contains a sample.
Do not turn the cartridge upside down.
Place the cartridge on a clean and flat surface only.
Do not use sample types, media, and volumes that are not approved for the test.
Always follow good laboratory practice to ensure the proper performance of this test.
Biological specimens, transfer devices, and used cartridges should be considered capable of transmitting infectious agents requiring standard precautions.
Handle potentially infectious patient samples and cartridges according to national laboratory standards and dispose of samples and cartridges according to regional and laboratory standards.
Be compliant with the national safety regulations and practices.

Note: Further information can be found in the safety data sheet(SDS) of the product. Please contact the customer support of your local distributor.

Additional Equipment & Consumables Required but not Provided

BoschVivalytic one analyser(reference numberF09G300115)
Pipettor (100–1000 μl)
Sterile filter pipette tips 100 –1000 µl
Swab collection kits – Regular Flocked Swab FLOQSwabs® 552C (COPAN Italia s.p.a.)
Transport medium – eNAT® 606C(COPANItalia s.p.a.)
Suitable protective clothing

Test Principle

Vivalytic Norovirus is a qualitative real-time RT-PCR-based test.

Storage and Usage Conditions

The product is stable until the expiry date if stored at +15 °C to +25 °C. Storage and usage uconditions can be taken either from the cartridge, pouch, or box label.
The cartridge has to be used at +15 °C to +25 °C, relative humidity <65 %, within 15 min upon pouch opening.
This maintains hygiene and avoids performance loss due to humidity. Prolonged exposure to humidity harms test performance.

Reagents

All reagents necessary for the sample processing are integrated into the cartridge.
The processing includes cell lysis, nucleic acid extraction, DNA amplification, and detection.
Reagents are PCR bead, binding buffer, washing buffer, and elution buffer. The PCR bead contains the DNA polymerase, primers, and probes.
A binding buffer facilitates the binding of nucleic acids during the purification process.
A washing buffer is a formulation of different salts and solvents to remove impurities e. g. proteins during the extraction process.
Elution Buffer is a low-salt buffer and contains the purified nucleic acids at the end of the extraction process.

Sample Type/Medium

The test is intended for use with stool swab samples in eNAT® medium (Regular
Flocked Swab FLOQSwabs® 552C, eNAT® transport medium Ref. 606C, COPAN Italia s.p.a.).
Collect and store samples as indicated in the manufacturer’s instructions.
In case the sample is not processed immediately after sample collection, nucleic acids will be preserved in an eNAT® transport medium for up to 4 weeks at room temperature and 4°C and up to 6 months at -20 °C to -80 °C (see Instructions for Use eNAT® transport medium5 ).

Sample Preparation

Use a Regular Flocked Swab FLOQSwabs® (COPAN Italia s.p.a.) to collect a small amount of stool by inserting the tip of the flocked swab into the stool sample and rotating it. Bloody, slimy, or watery areas of stools should be selected and collected.
After collection, examine the swab to make sure there is fecal material visible on the tip. In case it is not, again insert the flocked swab into the stool sample and rotate taking care that all the area of the swab tip is in contact with the sample.
Make sure that the swab is just covered with stool and remove excess stool by gently rotating the swab against the rim of the sample. After collection transfer the swab into the 2 ml Copan eNAT® tube with eNAT® transport medium.
Hold the swab shaft between thumb and finger, mash and mix the stool specimen against the side of the tube to evenly disperse and suspend the specimen in the preservation medium.
Hold the swab shaft close to the rim of the tube, and bend it at a 180-degree angle to break it off at the marked breakpoint. Discard the broken upper part of the swab shaft and tighten the cap. Shake the sample tube containing the swab sample and eNAT® medium (COPAN Italia s.p.a.) thoroughly at least for 10 seconds for homogenization. Use a pipettor to fill 300 μl of homogenized patient sample in the sample input of the cartridge.
Ensure to only pipet from the supernatant (top of the sample) to prevent the carryover of stool particles. In case of an excess amount of particles in the sample, it is recommended to place the sample tube on a flat surface and let the particles sediment for 5 minutes.
Do not use viscous samples that are difficult to pipette.

Test Result

After the automatic processing of the sample with the Vivalytic One analyzer the test result is shown on the screen of the Vivalytic One analyzer. The time to result is about 58 min. For high titer specimens, results are available after less than 44 min and the test run can be terminated earlier (see Chapter Test Termination).
The sample is classified either as Norovirus positive, Norovirus negative, or invalid. In case of a positive detection of Norovirus, the test is considered valid even if the Human Control is negative.
Detection of the human cell-based whole process control (Human Control) in negative samples shows a successful extraction procedure and excludes an inhibition of the PCR reaction.
The interpretation of the results is shown in the table below.

Norovirus	Human control	Validity	Result
+	+/–	valid	The sample is considered positive for Norovirus.
–	+	valid	The sample is considered negative for Norovirus.
–	–	invalid	Not evaluable.1

PCR – Curve and Cq Value

Real-time PCR curves (software-modified) are shown and classified as positive or negative by the software. In the case of positive curves, the respective Cq value is displayed.
Inconclusive results are marked by the software ( ⚠ ). Retesting is advised.

Invalid or Failed Tests

A test is rated as invalid if neither target DNA nor Human Control is detected.
Possible reasons for an invalid run might be poor sample quality due to a partial or complete absence of human cellular material in the sample. Results are displayed for an invalid test but are not allowed to be used for diagnostic interpretation.
Pay attention to using the correct sample type, sample collection, and storage of the sample and cartridges before the test run. If required, repeat the analysis with a new sample.
In case of a failed test, first, check for correct operating conditions of the Vivalytic One analyzer (refer to Vivalytic One analyzer’s Instructions for Use). Restart the Vivalytic one analyser. If the problem persists, contact the customer support of your local distributor.

Test Termination

As soon as a valid, positive Norovirus result is shown on the screen, the user has the option to finish the test.

Test Report

In the printed test report, pathogen, results, control, and information on the user, patient, and Vivalytic One analyzer are listed with a signature field.

Notice to Users in the EU

Any serious incident that has occurred to the device, should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Limitations

The results of the Vivalytic Norovirus test must be interpreted by a trained healthcare professional only. The results of the Vivalytic Norovirus test must not be used as the sole parameter for diagnosis.

A negative result does not exclude pathogens being present in the sample at a level below assay sensitivity or other pathogens being present not covered by this assay.
There is a risk of false negative or false positive results due to improperly collected, transported, or handled samples.
In borderline cases atypical PCR characteristics (e. g. flat curve with low or high Cq-value) can occur. In case of atypical characteristics results are not allowed to be used for diagnostic interpretation. Inconclusive results are marked by the software. Retesting is advised.
Vivalytic Norovirus is a qualitative real-time PCR test and does not provide a quantitative result.
A positive result does not necessarily mean that viable pathogens are present.
A negative result does not preclude Norovirus infection. It is recommended that negative tested samples are interpreted in the context of additional laboratory data An excess amount of stool may have inhibitory effects on the assay performance.

Analytical Performance Evaluation

Analytical Sensitivity (Limit of Detection)
- The limit of detection of the Vivalytic Norovirus test was determined as the lowest concentration of analyte that can be consistently detected (≥95% of samples tested under routine laboratory conditions using a defined type of sample). (Table 1)
Inclusivity
- To evaluate inclusivity, an in silico analysis (BLAST alignment) of the genomic sequence of various relevant Noroviruses against the sequence of the PCR primers and hydrolysis probe used in the Vivalytic Norovirus test for amplification and detection of the respective pathogens was performed. Inclusivity could be shown for strains listed in Table 2.
Exclusivity/ Analytical Specificity
- To exclude cross-reactivity (exclusivity), an in silico analysis (BLAST alignment) of the target region of Norovirus against the genomic sequence of various other pathogens representing common gastrointestinal pathogens or closely related species was conducted. There was no evidence of an interference (Table 3).
Reproducibility
- The reproducibility of the Vivalytic Norovirus test was established using a panel with 3 different concentrations of Norovirus. 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 positivity rate (Table 4a).
Repeatability
- The repeatability of the Vivalytic Norovirus test was established using a panel with 1 concentration (3x c95) of Norovirus. 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 substances that have the potential to interfere with the test.
Clinical Performance Evaluation Sensitivity and Specificity
- Sensitivity and specificity results derived from native liquid and soft human stool samples. Samples were collected in a clinical setting and compared with the results of reference methods.
- Samples for testing with Vivalytic Norovirus cartridges were freshly used or frozen for storage and prepared as described above in eNAT® (COPAN Italia S.p.A.).
- In the case of reference testing samples were prepared according to recommendations of used reference methods. In total, 159 samples were analyzed.SensitivityorPositive 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 6.
Technical Support
- If you require any support, or technical help, or have additional questions, please contact your local distributor or visit the Bosch Vivalytic website at www.bosch-vivalytic.com.
References

1. Schreier E: Gastrointestinale Infektionen durch Noroviren (Norwalk-like Viren). Der Mikrobiologe 2003; 13:171-176
2. Lopman B, Brown D, Koopmans M: Human caliciviruses in Europe. Journal of Clinical Virology 2002; 24:137-160
3. Oh D, Gaedicke G, Schreier E: Viral agents of acute gastroenteritis in German children: Prevalence and molecular diversity. J Med Virol 2003; 71:82-93
4. Chadwick PR, Beards G, Brown D, Caul EO, Cheesbrough J, Clarke I, Curry A, O’Brien S, Quigley K, Sellwood J, Westmoreland D: Management of hospital outbreaks of gastro-enteritis due to small round structured viruses. J Hosp Infect 2000; 45:1-10
5. COPAN Instructions for Use of Copan eNAT® Collection and Preservation System; Version EIFU002R01 Date 2021.06.

Symbols

Manufacturer
Date of manufacture
Expiry date
Lot number
Reference number
Contains tests
0123 CE mark
Serial number
Temperature limit
Do not use it if the package is damaged
For single-use only
Consult Instructions for Use
in vitro diagnostic medical device
Pipette the indicated sample volume in the sample input of the cartridge as marked by the black triangle.

WARNING

Hazard component in the cartridge

(F09G300919; binding buffer RB-BB-34a)
Guanidinium chloride; guanidine hydrochloride

Hazard statements

H302 Harmful if swallowed.
H315 Causes skin irritation.
H319 Causes serious eye irritation

Precautionary statements

P264 Wash hands thoroughly after handling.
P280 Wear protective gloves and eye/face protection.
P302+P352 IFONSKIN: Wash with plenty of water and soap.
P305+P351+P338 IFINEYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present, and easy to do. Continue rinsing.
P337+P313 Ifeyeirritationpersists: Get medical advice/attention.
P501 Dispose of contents/containers following local/regional/ national/ international regulation

Table 1 Limit of Detection (LoD)

**Norovirus GII***| 168700 copies /mL

Determined by using quantified clinical isolates for a spiking approach in eNAT® (COPAN) supplemented with approximately 1000 Human Bronchial/Tracheal Epithelial Cells (hPBTEC) and 6% (v/v) Stool Matrix Negative Control (artificial simulated matrix). Norovirus GI was confirmed at the 3x LoD (as determined for Norovirus GII) using artificial nucleic acid constructs.

Table 2 Inclusivity

Norovirus GI/GII

Strains validated for inclusivity via BLAST alignment

Table 3 – Exclusivity

Abiotrophia defective| Enterococcus faecium
Acinetobacter baumannii| Enterococcus gallinarum
Acinetobacter lwoffii| Enterococcus hirae
Adenovirus| Enterococcus raffinosus
Aeromonas caviae| Enterovirus
Aeromonas hydrophila| Escherichia blattae
Alcaligenes faecalis| Escherichia coli (Shiga toxin-producing) (STEC)
Anaerococcus set radius| Escherichia coli (Enteroaggregative) (EAEC)
Arcobacter butzleri| Escherichia coli (Enteroinvasive) (EIEC)
Arcobacter cryaerophilus| Escherichia coli (Enteropathogenic) (EPEC)
Ascaris lumbricoides| Escherichia coli (Enterotoxigenic) (ETEC)
Astrovirus| Escherichia coli (non-pathogenic) (K-12 MG1655)
Bacillus cereus| Escherichia coli (Enterohemorrhagic) (EHEC)
Bacillus subtilis| Escherichia fergusonii
Bacteroides caccae| Escherichia hermannii
Bacteroides fragilis| Escherichia vulneris
Bacteroides merdae| Eubacterium rectale
Bacteroides terrorism| Flavonifractor plautii
Bacteroides thetaiotaomicron| Fusobacterium varium
Bifidobacterium adolescentis| Gardnerella vaginalis
Bifidobacterium bifidum| Gemella morbillorum
Bifidobacterium longum| Giardia lamblia
Blastocystis hominins| Giardia muris
Campylobacter coli| Grimontia holiday
Campylobacter concisus| Hafnia alvei
Campylobacter curvus| Helicobacter fennelliae
Campylobacter fetus| Helicobacter pylori
Campylobacter gracilis| Helicobacter cinaedi
Campylobacter helveticus| Helicobacter hepaticus
Campylobacter hominins| Hepatitis A virus
Campylobacter hyointestinalis| Herpes Simplex Virus 2
Campylobacter jejuni| Hymenolepis nana
Campylobacter lari| Klebsiella oxytoca
Campylobacter mucosal| Klebsiella ozaena
Campylobacter rectus| Klebsiella pneumoniae
Campylobacter shower| Lactobacillus acidophilus
Campylobacter sputorum| Lactobacillus reuteri
Campylobacter upsaliensis| Lactococcus lactis
Candida albicans| Leminorella grimontii
Candida catenulate| Listeria grayi
Cedecea advise| Listeria innocua
Chilomastix messily| Listeria monocytogenes
Chlamydia trachomatis| Megamonas hypermegale
Citrobacter amalonaticus| Morganella morganii
Citrobacter freundii| Norovirus GIV
Citrobacter koseri| Pentatrichomonas hominis
Citrobacter selkie| Peptoniphilus saccharolytic
Clostridium beijerinckii| Peptostreptococcus anaerobic
Clostridium bifermentans| Plesiomonas shigelloides
Table 3 – Exclusivity

Clostridium bolted| Porphyromonas saccharolytic
Clostridium botulinum| Prevotella melaninogenica
Clostridium butyricum| Proteus mirabilis
Clostridium chauvoei| Proteus penner
Clostridium difficile (non-toxigenic)| Proteus vulgaris
Clostridium fallax| Providencia alcalifaciens
Clostridium haemolyticum| Providencia rettgeri
Clostridium histolyticum| Providencia stuartii
Clostridium inoculum| Pseudomonas aeruginosa
Clostridium methylpentosum| Pseudomonas fluorescens
Clostridium exile| Pseudomonas putida
Clostridium novyi| Rotavirus B
Clostridium orbiscindens| Rotavirus C
Clostridium paraputrificum| Rotavirus D
Clostridium perfringens| Rotavirus F
Clostridium ramosum| Rotavirus G
Clostridium cinders| Rotavirus H
Clostridium septicum| Rotavirus I
Clostridium sordellii| Ruminococcus bromine
Clostridium sphenoids| Saccharomyces boulardii
Clostridium spiroforme| Salmonella enterica
Clostridium sporogenes| Salmonella enterica spp. enterica serovar Typhimurium
Clostridium symbiosum| Salmonella enteritidis
Clostridium tertium| Salmonella subterranea
Clostridium tetani| Sapovirus
Collinsella aerofaciens| Serratia liquefaciens
Corynebacterium genitalium| Serratia marcescens
Coxsackie virus| Shigella boydii
Cryptosporidium canis| Shigella dysenteriae
Cryptosporidium cuniculus| Shigella flexneri
Cryptosporidium felis| Shigella sonnei
Cryptosporidium fetus| Staphylococcus aureus
Cryptosporidium hominins| Staphylococcus aureus subsp. aureus
Cryptosporidium meleagridis| Staphylococcus epidermidis
Cryptosporidium muris| Stenotrophomonas maltophilia
Cryptosporidium parvum| Streptococcus agalactiae
Cytomegalovirus| Streptococcus dysgalactiae
Desulfovibrio piger| Streptococcus dysgalactiae subsp. dysgalactiae
Dientamoeba fragilis| Streptococcus intermedius
Diphyllobothrium latum| Streptococcus pyogenes
Dysgonomonas capnocytophagoides| Streptococcus salivarius
Echovirus| Streptococcus uberis
Edwardsiella tarda| Taenia saginata
Eggerthella lenta| Trabulsiella guamensis
Encephalitozoon intestinalis| Veillonella parvula
Endolimax nana| Vibrio cholera
Entamoeba coli| Vibrio mimics
Entamoeba Hartmann| Vibrio parahaemolyticus
Entamoeba histolytica| Vibrio vulnificus
Entamoeba moshkovskii| Yersinia bedcovers
Entamoeba policy| Yersinia enterocolitica
Enterobacter aerogenes| Yersinia enterocolitica subsp. enterocolitica
Enterobacter cloacae| Yersinia frederiksenii
Enterococcus casseliflavus| Yersinia intermedia
Enterococcus decorum| Yersinia collarette
Enterococcus dispar| Yersinia pseudotuberculosis
Enterococcus faecalis| Yersinia Rohde
Table 4 a Reproducibility

c| No of| No of| No of| Proportion of| 95 % Wilson-| 95 % Pearson-
| total tests| pos. tests| neg. tests| positive/ negative results (%)| Score confidence interval (%)| Clopper confidence interval (%)
---|---|---|---|---|---|---
blank| 108| 0| 108| 100| 96.6% – 100%| 96.6% – 100%
3x c95| 108| 108| 0| 100| 96.6% – 100%| 96.6% – 100%
< c100| 108| 108| 0| 100| 96.6% – 100%| 96.6% – 100%

3x c95 = 95 % predicted positive agreement < c100 = < 100 % predicted positive agreement (verified with 3,33×106 copies/mL, c100 = 3,8×107 copies/mL)

Table 4 b Repeatability

LOT| No total tests| No of pos. tests (3x c95 )| Proportion of positive/ negative results (%)| 95 % Wilson-Score confidence interval (%)| 95 % Pearson- Clopper confidence interval (%)
1| 20| 20| 100| 83.9% – 100%| 83.2% – 100%
2| 20| 20| 100| 83.9% – 100%| 83.2% – 100%
3| 20| 20| 100| 83.9% – 100%| 83.2% – 100%
Total| 60| 60| 100| 94% – 100%| 94% – 100%

3x c95 = 95 % predicted positive agreement

Table 5 – Tested Substances for Interference

No interference detected
Cholesterol; 0.5 % (v/v)
Mucus; 3 mg/mL
Palmitic acid; 2mg/mL
Stearic Acid; 2mg/mL
Triglyceride; 0.8 % (w/v)
Whole blood; 3.0 (v/v)
Barium Sulfate; 1.3 % (w/v)
GLYICILAX for adults; 1.0 % (w/v)
GRÜNWALDER Sennalax film-coated tablet; 0.1 mg/mL
Hemorrhoid ointment with witch hazel; 1 % (v/v)
LOPERAMID-ratiopharm acute 2 mg film-coated tablet; 0.2 % (v/v)
MAALOXAN 25 mVal Liquid; 0.1 mg/mL
METRONIDAZOL Aristo 400 mg tablet; 0.5 % (w/v)
Naproxen axicur® tablet; 0.5 % (w/v)
Nonoxynol‐9; 1 % (w/v)
Nystatin STADA®; 1 % (w/v)
Postericort ointment; 0.5 % (v/v)
Claversal 4 g/60 ml clysms; 0.5 % (v/v)
Vancomycin; 1.4 mg/mL
Vaseline; 1 % (w/v)

Interference was experimentally verified at 3x LoD for Norovirus GII using a spiking approach in eNAT® (COPAN) plus 1000 hPBTEC and 6% (v/v) Stool Matrix Negative Control (artificial simulated matrix).

Table 6 – Clinical Sensitivity (PPA) [1] and Specificity (NPA) [2] for samples in eNAT® (95% confidence interval, clinical study)

94.23% (84.05 – 98.79%) *
100% (95.98 – 100%)

3 samples were detected as false negatives. In total, 159 clinical samples were tested within the scope of the clinical study. In this data set, 52 samples were found positive and 90 negative for Norovirus. All samples were tested with the reference tests from Seegene (Allplex™ GI-Virus Assay) and Vivalytic to determine the clinical performance of Vivalytic Norovirus. The discrepant result was verified using RIDAGENE RIDA®GENE HSP (R-Biopharm) (1 sample).