BIOMÉRIEUX

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VITEK® 2 ANC

INTENDED USE
These Instructions for Use correspond to the VITEK® 2 Systems 7.01 and 8.01 software. If you are not using VITEK® 2
Systems 7.01 or 8.01 software, please refer to the VITEK® 2 Systems Product Information that you received with your current
software version.
The VITEK® 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with VITEK® 2 Systems for the
automated identification of most clinically significant anaerobic organisms and Corynebacterium species. The VITEK® 2 ANC
identification card is a single-use disposable. For a list of claimed species, see the Organisms Identified section.
DESCRIPTION
The ANC card is based on established biochemical methods and newly developed substrates. There are 36 biochemical
tests measuring carbon source utilization and enzymatic activities. Final results are available in approximately six hours.
For a list of well contents, see the ANC Well Contents table.

ANC Well Contents

Well Test Mnemonic Amount/Well

4 D-GALACTOSE dGAL 0.3 mg
5 Leucine ARYLAMIDASE LeuA 0.023 mg
6 ELLMAN ELLM 0.03 mg
7 Phenylalanine ARYLAMIDASE PheA 0.026 mg
8 L-Proline ARYLAMIDASE ProA 0.023 mg
10 L-Pyrrolidonyl-ARYLAMIDASE PyrA 0.018 mg
11 D-CELLOBIOSE dCEL 0.3 mg
13 Tyrosine ARYLAMIDASE TyrA 0.0279 mg
15 Ala-Phe-Pro-ARYLAMIDASE APPA 0.038 mg
18 D-GLUCOSE dGLU 0.3 mg
20 D-MANNOSE dMNE 0.3 mg
22 D-MALTOSE dMAL 0.3 mg
28 SACCHAROSE/SUCROSE SAC 0.3 mg
30 ARBUTIN ARB 0.1875 mg
33 N-ACETYL-D-GLUCOSAMINE NAG 0.3 mg
34 5-Bromo-4-chloro-3-indoxyl-beta-glucoside BGLUi 0.006 mg
36 UREASE URE 0.15 mg
37 5-Bromo-4-chloro-3-indoxyl-beta-glucuronide BGURi 0.006 mg
39 BETA-GALACTOPYRANOSIDASE Indoxyl BGALi 0.006 mg
41 ALPHA-ARABINOSIDASE AARA 0.0324 mg
42 5-Bromo-4-chloro-3-indoxyl-alpha-galactoside AGALi 0.006 mg
43 BETA-MANNOSIDASE BMAN 0.036 mg
44 ARGININE GP ARG 0.15 mg
45 PYRUVATE PVATE 0.15 mg
51 MALTOTRIOSE MTE 0.3 mg

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Well Test Mnemonic Amount/Well

53 ESCULIN hydrolysis ESC 0.0225 mg
54 BETA-D-FUCOSIDASE BdFUC 0.0342 mg
55 5-Bromo-4-chloro-3-indoxyl-beta- N-acetyl-glucosamide BNAGi 0.006 mg
56 5-Bromo-4-chloro-3-indoxyl-alpha-mannoside AMANi 0.006 mg
57 ALPHA-L-FUCOSIDASE AlFUC 0.0342 mg
59 PHOSPHATASE PHOS 0.05 mg
60 L-ARABINOSE lARA 0.3 mg
61 d-Ribose 2 dRIB2 0.3 mg
62 Phenylphosphonate OPS 0.024 mg
63 ALPHA-L-ARABINOFURANOSIDE AARAF 0.015 mg
64 D-XYLOSE dXYL 0.3 mg

Note: Other well numbers between 1 and 64 not designated in this table are empty.
PRECAUTIONS
Note: For industry customers that need assistance on selecting the correct VITEK® 2 identification card, please refer to the
VITEK® 2 Compact Instrument User Manual chapter, "Guidance to Select a VITEK® 2 Identification Card."
• For In Vitro Diagnostic Use Only.
• For US Only: Caution: US Federal Law restricts this device to sale by or on the order of a licensed practitioner.
• For professional use only.
• Suspensions not within the appropriate zone on the VITEK® 2 DensiCHEK™ Plus or the VITEK® 2 DensiCHEK™ may
compromise card performance.
• Do not use the card after the expiration date shown on the package liner.
• Store the card unopened in the package liner. Do not use the card if the protective package liner is damaged or if no
desiccant is present.
• Allow the card to come to room temperature before opening the package liner.
• Do not use powdered gloves. Powder may interfere with the optics.
• Use of culture media other than the recommended types must be validated by the customer laboratory for acceptable
performance.
• A Gram stain should be performed to determine an organism’s Gram reaction and morphology prior to selecting the
identification card to inoculate.
• The card performs as intended only when used in conjunction with VITEK® 2 Systems, following the instructions
contained in these Instructions for Use.
• Do not use glass test tubes. Use clear plastic (polystyrene) tubes only. Variation exists among test tubes of standard
diameter. Carefully place the tube into the cassette. If resistance is encountered, discard and try another tube that does
not require pressure to insert.
• Prior to inoculation, inspect cards for tape tears or damage to the tape and discard any that are suspect. Check the
saline level in the tubes after the cassette has been processed to ensure proper filling of card.
• VITEK® 2 60 or VITEK® 2 XL: Eject improperly filled cards.
• VITEK® 2 Compact: Do not load improperly filled cards.
• Give special consideration to specimen source and patient drug or antimicrobic regimen.
• Interpretation of test results requires the judgment and skill of a person knowledgeable in microbial identification testing.
Additional testing may be required. (See the Supplemental Tests section.)

Warning: All patient specimens, microbial cultures, and inoculated VITEK® 2 cards, along with associated materials,
are potentially infectious and should be treated with universal precautions.17,18
Warning: All hazardous waste must be disposed of by following your local inspecting agency's guidelines.
STORAGE CONDITIONS
Upon receipt, store VITEK® 2 ANC cards unopened in their original package liner at 2°C to 8°C.

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SPECIMEN PREPARATION
For specimen preparation information, see the Culture Requirements Table.

Culture Requirements

VITEK® 2 Media Age of Culture1 Incubation Inoculum Dilution for Age of

Card Conditions Density AST Suspension
Before Loading
Instrument
ANC Corynebacteria: Corynebacteria: Corynebacteria: 2.70 to 3.30 N/A3 ≤ 30 minutes
McFarland
CBA2 18 to 24 hours 35°C to 37°C
Standard
CNA CO2 or non-
CO2
TSAB
TSAHB
Anaerobes: Anaerobes: Anaerobes:
CBA2 18 to 72 hours 35°C to 37ºC
CDC2 anaerobic
environment
BRU
CHBA
TSAB
TSAHB
Gram-Positive
Anaerobes ONLY:
CNA
CDC PEA
PEA

1Cultures with scant or poor growth may give unidentified or incorrect results even when the Age of Culture requirements are
met.
2These media were used in the identification product database development and will give optimal performance.
3N/A = not applicable
Culture Requirements Table — Media Abbreviations
BRU = Brucella Agar with 5% Sheep Blood, Hemin, and Vitamin K
CBA = Columbia Blood Agar with 5% Sheep Blood
CDC = CDC Anaerobe Agar with 5% Sheep Blood
CDC PEA = CDC Blood Agar with PEA
CHBA = Columbia Horse Blood Agar
CNA = Columbia CNA Agar with 5% Sheep Blood
PEA = Phenylethyl Alcohol Agar with 5% Sheep Blood
TSAB = Trypticase Soy Agar with 5% Sheep Blood
TSAHB = Trypticase Soy Agar with 5% Horse Blood
TEST PROCEDURE
Materials
When used with VITEK® 2 instrumentation, the ANC card is a complete system for routine identification testing of most
clinically significant anaerobic organisms and Corynebacterium species.

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Required materials are:

• VITEK® 2 ANC Card
• VITEK® 2 DensiCHEK™ Plus Kit or VITEK® 2 DensiCHEK™ Kit
• DensiCHEK™ Plus Standards Kit or DensiCHEK™ Standards Kit
• VITEK® 2 Cassette
• Sterile saline (aqueous 0.45% to 0.50% NaCl, pH 4.5 to 7.0)
• 12 mm x 75 mm clear plastic (polystyrene) disposable test tubes
• Sterile sticks or swabs
• Appropriate agar medium (see Culture Requirements table).

Optional accessories:
• Adjustable volume saline dispenser
• Loops
• Pre-dispensed saline test tubes (aqueous 0.45% to 0.50% NaCl, pH 4.5 to 7.0)
• Test tube caps
• Vortex

Procedure
Warning: Failure to follow instructions and recommendations provided in this section for performing laboratory
tasks may cause erroneous or delayed results.
For product-specific information, see the Culture Requirements table.
Note: Prepare the inoculum from a pure culture, according to good laboratory practices. In case of mixed cultures, a re-
isolation step is required. It is recommended that a purity check plate be done to ensure that a pure culture was used for
testing.
1. Do one of the following:
• Select isolated colonies from a primary plate if culture requirements are met.
• Subculture the organism to be tested to appropriate agar medium and incubate accordingly.
2. Aseptically transfer 3.0 mL of sterile saline (aqueous 0.45% to 0.50% NaCl, pH 4.5 to 7.0) into a clear plastic
(polystyrene) test tube (12 mm x 75 mm).
3. Use a sterile stick or swab to transfer a sufficient number of morphologically similar colonies to the saline tube prepared in
step 2. Prepare a homogenous organism suspension with a density equivalent to a McFarland No. 2.70 to 3.30 using a
calibrated VITEK® 2 DensiCHEK™ Plus or VITEK® 2 DensiCHEK™.
Note: Age of suspension must not exceed 30 minutes before inoculating card.
4. Place the suspension tube and ANC card in the cassette.
5. Refer to the appropriate Instrument User Manual for instructions on data entry and how to load the cassette into the
instrument.
6. In addition to the internal tests included on the card, three offline tests are required in the ANC ID algorithm. The offline
tests selected for use in the ANC ID product are Gram stain, morphology, and aerotolerance. The ANC Offline Test results
can be entered at the Smart Carrier Station (VITEK® 2 60 or VITEK® 2 XL only) or the workstation.

ANC Offline Tests

Test Name Test Result Definition

AERO Aerotolerance – Anaerobe
+ Aerobe
? Facultative
GRAM Gram stain results – Gram Negative
+ Gram Positive
? Gram Variable

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Test Name Test Result Definition

MORPH Morphology – Bacilli
+ Cocci
? Coccobacilli
7. Follow your local inspecting agency's guidelines for disposal of hazardous waste.
RESULTS
Identification Analytical Techniques
VITEK® 2 Systems identify an organism by using a methodology based on the characteristics of the data and knowledge
about the organism and reactions being analyzed. Sufficient data have been collected from known strains to estimate the
typical reactions of the claimed species to a set of discriminating biochemicals. If a unique identification pattern is not
recognized, a list of possible organisms is given, or the strain is determined to be outside the scope of the database.
The printed lab report contains suggestions for any supplemental tests necessary to complete the identification. If the tests
are not sufficient to complete the identification, then standard microbiology references and literature should be consulted.
Certain species may belong to a slashline (mixed) taxa identification. This occurs when the biopattern is the same for
the taxa listed. Supplemental tests may be used to separate slashline taxa. The species in the ANC Slashline Taxa table
belong to the ANC slashline taxa.

ANC Slashline Taxa

Slashline Name Species Belonging to the Slashline

Clostridium group Clostridium innocuum
Clostridium limosum
Clostridium novyi

Identification Card Qualifying Messages

ID Message Confidence Choices % Probability Comments

Level
Excellent 1 96 to 99 N/A
Very Good 1 93 to 95 N/A
Good 1 89 to 92 N/A
Acceptable 1 85 to 88 N/A
Low Discrimination 2 to 3 Sum of choices = 100; after Two to three taxa exhibit same
resolution to one choice, biopattern.
percent probability reflects Separate by supplemental testing.
the number associated with
selected choice.
Inconclusive >3 N/A Either > 3 taxa exhibit same biopattern
or or or
Unidentified Organism 0 Very atypical biopattern. Does not
correspond to any taxon in the
database. Check Gram stain and
purity.

PERCENT PROBABILITY
As part of the identification process, the software compares the test set of reactions to the expected set of reactions of each
organism, or organism group, that can be identified by the product. A quantitative value, the percent probability, is calculated
and relates to how well the observed reactions compare to the typical reactions of each organism. A perfect match between
the test reaction pattern and the unique reaction pattern of a single organism, or organism group, would provide a percent
probability of 99. When a perfect match is not obtained, it is still possible for the reaction pattern to be sufficiently close to that

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of an expected reaction pattern such that a clear decision can be provided about the organism identification. The range of
percent probabilities in the one-choice case is 85 to 99. Values closer to 99 indicate a closer match to the typical pattern for
the given organism.
When the reaction pattern is not sufficient to discriminate between two to three organisms, the percent probabilities reflect
this ambiguity. The reported probability values indicate, relatively, the order in which the reaction pattern best corresponds to
the listed possibilities. The order does not, however, suggest that the pattern match to one of the possible identifications is
clearly superior to another. The probability characteristic of an overall sum of 100 is retained through the calculation process.
After resolution to one choice, the probability characteristic of the single choice is retained.
ADDITIONAL INFORMATION ON LAB REPORT
Supplemental test — External (offline) test that allows the user to resolve a slashline or Low Discrimination identification.
Numbers in parentheses indicate percent positive reaction for the species/test listed.
Contraindicating test — Test result that is unusual for a reported taxon.

Notes Associated with Certain Taxa

Taxa Note
Actinomyces israelii Actinomyces israelii represents a complex of two closely
related species, A. israelii and A. gerencseriae (formerly
known as A. israelii serotype II).
Corynebacterium diphtheriae Critical pathogen. The species identified may have
significance to patient or sample outcome and can be
stopped for review.

Notes Associated with an Improperly Filled Card or with a Negative Profile (Biopattern)
• For the case where the time between two readings is greater than 40 minutes: “CARD ERROR — Missing data.”
• For the case where there is a negative profile: “Organism with low reactivity biopattern — please check viability.”
• When a biopattern is calculated for an unknown organism that is completely negative or consists of both negative tests
and tests that fall within the uncertainty zone, the identification call will be “Non or low reactive biopattern.”

The following non-reactive species could potentially trigger this note if a test was atypical or fell within the uncertainty zone:
• Clostridium clostridioforme
• Fusobacterium nucleatum
• Fusobacterium mortiferum

QUALITY CONTROL
Quality control organisms and their expected results are listed in the VITEK® 2 ANC Quality Control Tables. Process these
according to the procedure for test isolates outlined in this document.
Certification Statement
This is to certify that bioMérieux complies with ISO 13485 and FDA Quality System Regulation (QSR) requirements for
design, development, and manufacture of microbial identification systems.
Frequency of Testing
Currently, it is recommended that you use your most stringent inspecting agency’s guidelines for frequency of identification
product testing.
Common practice is to perform QC upon receipt of shipment of the test kits. Reactions must follow Instructions for Use
results.
If the results do not meet the criteria, subculture for purity and repeat the test. If discrepant results are repeated, perform an
alternate identification method and contact bioMérieux.
Testing and Storage of QC Organisms
1. Rehydrate the organism according to the manufacturer's instructions.
2. Corynebacterium: Use Columbia Blood agar with 5% sheep blood (CBA) and incubate at 35°C to 37°C in non-CO2
aerobic conditions. Incubate for 18 to 24 hours or until sufficient growth is obtained.

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3. Anaerobes: Use Columbia Blood agar with 5% sheep blood and incubate at 35°C to 37°C in anaerobic conditions for 18
to 24 hours or until sufficient growth is obtained.
4. Check for purity. Perform second subculture for testing.
5. Corynebacterium: Use Columbia Blood agar with 5% sheep blood and incubate at 35°C to 37°C in non-CO2 aerobic
conditions. Incubate for 18 to 24 hours.
6. Anaerobes: Use Columbia Blood agar with 5% sheep blood and incubate at 35°C to 37°C in anaerobic conditions for 18
to 24 hours.
Short-Term Storage Conditions - Corynebacterium
1. Streak to a CBA plate or slant.
2. Incubate at 35°C to 37°C in non-CO2 aerobic conditions. Incubate for 18 to 24 hours.
3. Refrigerate at 2°C to 8°C for up to five days.
4. Subculture to CBA. Incubate at 35°C to 37°C in non-CO2 aerobic conditions for 18 to 24 hours. Use for QC.
Short-Term Storage Conditions - Anaerobes
1. Streak to a CBA plate or slant.
2. Incubate at 35°C to 37°C in anaerobic conditions for 18 to 24 hours or until sufficient growth is obtained.
3. Store at room temperature in anaerobic conditions for up to five days.
4. Subculture to CBA. Incubate at 35°C to 37°C in anaerobic conditions for 18 to 24 hours. Use for QC.
Long-Term Storage Conditions
1. Make a heavy suspension in Tryptic Soy Broth (TSB) with 15% glycerol.
2. Freeze at -70°C.
3. Subculture to CBA twice before running QC.
Note: Avoid repeated thawing and refreezing by either freezing in single-use aliquots or removing a small portion of frozen
organism preparation with a sterile applicator stick.
STREAMLINED QUALITY CONTROL
Note: Industrial Use Only laboratories should perform quality control following the Streamlined Quality Control section. No
additional testing is required for these users.
As there are no substrates that are consistently sensitive to degradation during shipping conditions, streamlined quality
control may be conducted by testing two strains: one that is mostly positive and the other, which is mostly negative for
reactions on ANC. (See ANC Quality Control tables for more details).
COMPREHENSIVE QUALITY CONTROL
Customers who do not qualify for streamlined quality control testing are required to perform comprehensive quality control
testing, which entails demonstration of a positive and negative reaction for each substrate of an identification product.4
In order to qualify initially for streamlined quality control testing, the CLSI® M50-A standard requires that the user perform and
document either of the following:3
• Verification testing to show that performance is equivalent to the manufacturer's claims.
• Comprehensive quality control testing of at least three lots over at least three different seasons.

Refer to the complete CLSI® M50-A standard for information regarding continued qualification and further details of
requirements and responsibilities for both the user and the manufacturer related to streamlined quality control testing.
ANC Quality Control Tables:
Clostridium septicum ATCC® 12464™ (for streamlined or comprehensive quality control)
Bacteroides ovatus ATCC® BAA-1296™ (for streamlined or comprehensive quality control)
Bacteroides vulgatus ATCC® 8482™ (for comprehensive quality control)
Clostridium perfringens ATCC® 13124™ (for comprehensive quality control)
Clostridium sordellii ATCC® 9714™ (for comprehensive quality control)
Corynebacterium striatum ATCC® BAA-1293™ (for comprehensive quality control)
Parabacteroides distasonis ATCC® BAA-1295™ (for comprehensive quality control)

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The ANC card typically identifies the quality control organisms as one-choice or within a low discrimination or slashline
identification. However, strains are chosen for reaction performance over identification performance. Therefore, an
unidentified or misidentified result may occur when all expected quality control reactions are correct.

QC Organism: Clostridium septicum ATCC® 12464™ (for streamlined or comprehensive quality control)

dGAL - dCEL - SAC - BGALi + MTE - PHOS - GRAM +

LeuA - TyrA - ARB - AARA v ESC - IARA - MORPH -
ELLM - APPA - NAG - AGALi - BdFUC + dRIB2 - AERO -
PheA - dGLU - BGLUi - BMAN - BNAGi - OPS +
ProA - dMNE - URE - ARG - AMANi v AARAF -
PyrA v dMAL - BGURi - PVATE - AIFUC - dXYL -

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

QC Organism: Bacteroides ovatus ATCC® BAA-1296™ (for streamlined or comprehensive quality control)

dGAL + dCEL + SAC v BGALi + MTE + PHOS v GRAM -

LeuA - TyrA - ARB v AARA + ESC + IARA + MORPH -
ELLM + APPA + NAG + AGALi + BdFUC v dRIB2 + AERO -
PheA - dGLU + BGLUi v BMAN v BNAGi - OPS v
ProA - dMNE + URE - ARG - AMANi v1 AARAF +
PyrA - dMAL + BGURi v PVATE v AIFUC v dXYL v

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive.

1Reaction is mostly positive although occasional negative reaction may occur.

QC Organism: Bacteroides vulgatus ATCC® 8482™ (for comprehensive quality control)

dGAL v dCEL v SAC v BGALi v MTE v PHOS + GRAM –

LeuA v TyrA v ARB v AARA + ESC v IARA v MORPH –
ELLM + APPA + NAG v AGALi v BdFUC + dRIB2 v AERO –
PheA v dGLU v BGLUi v BMAN v1 BNAGi v1 OPS v
ProA v dMNE v URE v ARG v AMANi - AARAF +
PyrA v dMAL v BGURi v1 PVATE v AIFUC + dXYL +

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

1Reaction is mostly positive although occasional negative reaction may occur.

QC Organism: Clostridium perfringens ATCC® 13124™ (for comprehensive quality control)

dGAL v dCEL v SAC + BGALi v MTE + PHOS + GRAM +

LeuA v TyrA v ARB v AARA v ESC v IARA v MORPH –
ELLM – APPA – NAG v AGALi + BdFUC v dRIB2 + AERO –
PheA v dGLU v BGLUi v BMAN v BNAGi v OPS +
ProA v dMNE v URE v ARG + AMANi v AARAF –
PyrA + dMAL + BGURi v PVATE – AIFUC v dXYL v

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

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QC Organism: Clostridium sordellii ATCC® 9714™ (for comprehensive quality control)

dGAL – dCEL v SAC – BGALi – MTE v PHOS v GRAM +

LeuA v TyrA v ARB v AARA – ESC – IARA v MORPH –
ELLM v APPA v NAG v AGALi – BdFUC – dRIB2 v AERO –
PheA v dGLU v BGLUi – BMAN – BNAGi v OPS –
ProA + dMNE - URE + ARG v AMANi – AARAF v
PyrA v dMAL v BGURi v PVATE v AIFUC v dXYL –

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

QC Organism: Corynebacterium striatum ATCC® BAA-1293™ (for comprehensive quality control)

dGAL + dCEL – SAC + BGALi – MTE – PHOS – GRAM +

LeuA + TyrA + ARB – AARA v ESC v IARA – MORPH –
ELLM v APPA v NAG – AGALi v BdFUC – dRIB2 – AERO +
PheA v dGLU + BGLUi v BMAN v BNAGi v OPS v
ProA + dMNE + URE v ARG v AMANi v AARAF v
PyrA – dMAL – BGURi v PVATE + AIFUC v dXYL v

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

QC Organism: Parabacteroides distasonis ATCC® BAA-1295™ (for comprehensive quality control)

dGAL v dCEL v SAC v BGALi v MTE v PHOS v GRAM –

LeuA v TyrA v ARB + AARA v ESC + IARA v MORPH –
ELLM v APPA v NAG + AGALi v BdFUC v dRIB2 v AERO –
PheA v1 dGLU v BGLUi + BMAN v BNAGi v OPS v
ProA v dMNE v URE v ARG v AMANi v AARAF v
PyrA + dMAL v BGURi – PVATE v AIFUC – dXYL v

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

1Reaction is mostly positive although occasional negative reaction may occur.
LIMITATIONS
The VITEK® 2 ANC card cannot be used with a direct clinical specimen or sample or other sources containing mixed flora.
Newly described or rare species may not be included in the ANC database. Selected species will be added as strains
become available.
Warning: Testing of unclaimed species may result in an unidentified result or a misidentification.
PERFORMANCE CHARACTERISTICS
In a multi-site clinical study*, the performance of the VITEK® 2 ANC identification card was evaluated using 365 clinical and
stock isolates of both commonly and rarely observed species. The reference identification was determined using 16S rRNA
gene sequencing. Overall, the VITEK® 2 ANC correctly identified 94.0% of these isolates, including 9.0% low discrimination
with the correct species listed. Misidentifications occurred at 5.8% and no identifications occurred at 0.3%.
*Data on file at bioMérieux, Inc.
ORGANISMS IDENTIFIED
• Actinobaculum schaalii
• Actinomyces bovis
• Actinomyces israelii
• Actinomyces meyeri
• Actinomyces naeslundii
• Actinomyces neuii

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• Actinomyces odontolyticus
• Actinomyces turicensis
• Anaerococcus prevotii
• Arcanobacterium haemolyticum
• Atopobium vaginae
• Bacteroides caccae
• Bacteroides eggerthii
• Bacteroides fragilis
• Bacteroides ovatus
• Bacteroides stercoris
• Bacteroides thetaiotaomicron
• Bacteroides uniformis
• Bacteroides vulgatus
• Bifidobacterium spp.
• Campylobacter ureolyticus (formerly known as Bacteroides ureolyticus)
• Clostridium baratii
• Clostridium bifermentans
• Clostridium butyricum
• Clostridium cadaveris
• Clostridium chauvoei
• Clostridium clostridioforme
• Clostridium difficile
• Clostridium glycolicum
• Clostridium group
• Clostridium histolyticum
• Clostridium paraputrificum
• Clostridium perfringens
• Clostridium ramosum
• Clostridium septicum
• Clostridium sordellii
• Clostridium sporogenes
• Clostridium subterminale
• Clostridium tertium
• Collinsella aerofaciens
• Corynebacterium amycolatum
• Corynebacterium diphtheriae
• Corynebacterium jeikeium
• Corynebacterium minutissimum
• Corynebacterium pseudodiphtheriticum
• Corynebacterium striatum
• Corynebacterium ulcerans
• Corynebacterium urealyticum
• Eggerthella lenta
• Eggerthia catenaformis (formerly known as Lactobacillus catenaformis)
• Eubacterium limosum
• Finegoldia magna
• Fusobacterium mortiferum
• Fusobacterium necrophorum
• Fusobacterium nucleatum
• Fusobacterium varium
• Lactobacillus acidophilus
• Lactobacillus buchneri

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• Lactobacillus casei
• Lactobacillus fermentum
• Lactobacillus gasseri
• Lactobacillus hilgardii
• Lactobacillus parabuchneri
• Lactobacillus paracasei
• Lactobacillus plantarum
• Microbacterium flavescens
• Microbacterium spp.
• Parabacteroides distasonis
• Parabacteroides merdae
• Parvimonas micra
• Peptoniphilus asaccharolyticus
• Peptoniphilus indolicus
• Peptostreptococcus anaerobius
• Porphyromonas gingivalis
• Prevotella bivia
• Prevotella buccae
• Prevotella disiens
• Prevotella denticola
• Prevotella intermedia
• Prevotella melaninogenica
• Prevotella oralis
• Prevotella oris
• Propionibacterium acnes
• Propionibacterium granulosum
• Propionibacterium propionicum (formerly known as Propionibacterium propionicus)
• Staphylococcus saccharolyticus
• Trueperella pyogenes (formerly known as Arcanobacterium pyogenes)
• Turicella otitidis
• Veillonella spp.

For 8.01 Software Users

• Terrisporobacter glycolicus (formerly known as Clostridium glycolicum)

SUPPLEMENTAL TESTS

ANC Supplemental Tests

Abbreviation Test Name Description Comments Reference

AFUC Alpha-Fucosidase Presence of enzyme Presence of enzyme is 16
cleaves substrate indicated by generation of a
generating detectable colored or fluorescent
leaving group (e.g., p- product, or a non-colored
nitrophenol, methyl product that forms color
umbelliferone, beta- upon addition of a specific
naphthylamide, p- reagent.
nitroaniline, 7-amino-
methyl-coumarin).
BNAG BETA-N-ACETYL-GLUCOSAMINIDASE Presence of respective Presence of enzyme is 16
enzyme cleaves substrate indicated by generation of a
generating detectable colored or fluorescent
leaving group (e.g., p- product, or a noncolored
nitrophenol, methyl product that forms color
umbelliferone, beta- upon addition of a specific
naphthylamide, beta- reagent.
naphthol, p-nitroaniline, 7-
amidomethyl-coumarin).

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Abbreviation Test Name Description Comments Reference

Branch.flt BRANCHING FILAMENTS Appearance of branching N/A 8, 9, 15
filaments on microscopic
examination.
CAT CATALASE Colony placed on a drop of N/A 7, 9, 15, 16
hydrogen peroxide
produces gas bubbles. The
bacteria that contain
cytochrome enzyme are
catalase positive.
ESCULIN ESCULIN hydrolysis Hydrolysis of esculin forms Some tests also appear on 5, 8, 9, 15, 16
esculetin, which produces a the ANC card but are
black pigment in the recommended as
presence of iron salts. supplemental tests since
results of conventional
macromethods may differ
from rapid commercial
micromethods.
GELATIN Gelatin hydrolysis Mediated by a gelatinase N/A 7, 9, 15, 16
enzyme. A positive reaction
is evidenced by liquefaction
of the gelatin substrate.
IND INDOLE Ability of certain species to N/A 7, 15, 16
split indole from tryptophan
detected by a colored
product revealed with a
specific reagent (e.g.,
Kovacs, Ehrlichs, DMAC
reagents).
LECITHIN. LECITHINASE A precipitate surrounding N/A 7, 9, 16
the colony on egg yolk agar
indicates lecithinase activity
of alphatoxin produced by
the organism.
LIP LIPASE An iridescent pearly sheen N/A 7, 9, 16
on the surface of the colony
on egg yolk agar indicates
lipase activity.
LIPOPHILY LIPOPHILY Lipophilic Enhanced growth in the 16
presence of lipids in the
culture medium.
NO3 NITRATE REDUCTION Test for the ability to reduce N/A 7, 9, 15, 16
nitrate to nitrite or nitrogen
gas.
PAL ALKALINE PHOSPHATASE Presence of enzyme Presence of enzyme is 16
cleaves substrate indicated by generation of a
generating detectable colored or fluorescent
leaving group. product, or a non-colored
product that forms color
upon addition of a specific
reagent.
PIGMENT Pigment Ability of certain species to N/A 16
produce pigmented colonies
on nondifferential media.
Point.ends POINTED ENDS Appearance of thin gram- N/A 9
negative rods with pointed
ends is a microscopic
characteristic for
Fuscobacterium nucleatum.
PYRAZINAM. PYRAZINAMIDASE Test for the activity of the N/A 16
enzyme pyrazinamidase,
which hydrolyses
pyrazinamide to pyrazinoic
acid.

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VITEK® 2 ANC 043907- 02 - en - 2016-10

Abbreviation Test Name Description Comments Reference

SPOR SPORE Microscopic examination for N/A 16
spores. Phase-contrast
microscopy is
recommended.
UREASE Urease Hydrolysis of urea releases Some tests also appear on 7, 8, 9, 15, 16
ammonia resulting in the ANC card but are
alkalinization of the medium recommended as
observed with a pH supplemental tests since
indicator (e.g., red color results of conventional
formation in the presence of macromethods often differ
phenol red). from rapid commercial
micromethods.
lARABINOSE L-ARABINOSE acidification Anaerobe: PRAS* method Some tests also appear on 7, 8, 9, 15, 16,
the ANC card but are 19
dCELLOB DCELLOBIOSE acidification Corynebacterium: acid from
carbohydrate. recommended as
dFRUCTOSE D-FRUCTOSE acidification supplemental tests since
Acidification of carbon results of conventional
dGALACTOSE DGALACTOSE acidification
source observed with pH macromethods often differ
dGLUCOSE D-GLUCOSE acidification indicator (e.g., phenol red, from rapid commercial
LACTOSE Lactose acidification bromcresol purple). micromethods.
dMALTOSE D-MALTOSE acidification
dMANNITOL D-MANNITOL acidification
dMANNOSE D-MANNOSE acidification
dRAFFINOSE dRAFFINOSE acidification
lRHAMNOSE L-RHAMNOSE acidification
dRIBOSE dRIBOSE acidification
SACCHAROSE SACCHAROSE/SUCROSE acidification
SALICIN SALICIN
STARCHac STARCH acidification
dTREHALOSE dTREHALOSE acidification
XYL XYLOSE
XYLAN XYLAN acidification

*PRAS: Pre-reduced anaerobically sterilized media

REFERENCES
1. Balows, A., W.J. Hausler, K.L. Herrmann, H.D. Isenberg, H.J. Shadomy (ed.). 1991. Manual of Clinical Microbiology, 5th
ed. American Society for Microbiology, Washington, D.C.
2. Balows, A., H.G. Truper, M. Dworkin, W. Harder, and K-H. Schleifer (ed.). 1992. The Prokaryotes- a Handbook on the
Biology of Bacteria: Exophysiology, Isolation, Identification, Applications, 2nd ed., Volume II. Springer-Verlag, New York.
3. Clinical and Laboratory Standards Institute, M50-A, Quality Control for Commercial Microbial Identification Systems;
Approved Guideline, Vol. 28 No. 23.
4. Clinical Laboratory Improvement Amendments of 1988. 42 U.S.C 263a. PL 100-578. 1988.
5. De Vos, P., Garrity, G., Jones, D., Krieg, N., Ludwig, W., Rainey, F., Schleifer, K., Whitman, W. Bergey's' Manual of
Systematic Bacteriology, Second Edition, Volume Three the Firmicutes, Springer Publishing Dordrecht, 2009.
6. Difco Manual Dehydrated Culture Media and Reagents for Microbiology. 10th ed. 1984
7. Holdeman, L.V., Cato, E.P., Moore, W.E.C., Anaerobe Laboratory Manual 4th ed. Blacksburg VA.: VPI Anaerobe
Laboratory, 1977.
8. Holt, J.G., N.R. Krieg, P.H.A. Sneath, J.T. Staley, S.T. Williams (ed.). 1994. Bergey's Manual of Determinative
Bacteriology, 9th ed. Williams and Wilkins, Baltimore.
9. Jousimies-Somer, H., P. Summanen, D. M. Citron, E.J. Baron, H.M. Wexler, S.M. Finegold (ed) 2002 Wadsworth - KTL
Anaerobic Bacteriology Manual, 6th ed. Star Publishing Belmont California.
10. Koneman, E.W., S.D. Allen, W. M. Janda, P.C. Schreckenberger, W.C. Winn (ed.). 1992. Color Atlas and Textbook of
Diagnostic Microbiology, 4th ed. Lippincott Publishing Company, Philadelphia,PA.
11. Koneman, E.W., S.D. Allen, W.M. Janda, P.C. Schreckenberger, W.C. Winn (ed.). Color Atlas and Textbook of Diagnostic
Microbiology, 5th ed. 1997 Lippincott, Philadelphia, New York.

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VITEK® 2 ANC 043907- 02 - en - 2016-10

12. Krieg, N.R., and J.G. Holt. (ed.) 1984. Bergey's Manual of Systematic Bacteriology, 9th ed. Williams and Wilkins,
Baltimore.
13. Manafi, M., W. Kneifel, and S. Bascomb. 1991. Fluorogenic and chromogenic substrates used in bacterial diagnostics.
Microbiol. Rev. 55:335-348.
14. Murray, P.R., E.J. Baron, M.A. Pfaller, F.C. Tenover and R.H. Yolken (ed.) 1999. Manual of Clinical Microbiology, 7th ed.
American Society for Microbiology, Washington, D.C.
15. Murray, P.R., E.J. Baron, J.H. Jorgensen, M.A. Pfaller, and R.H. Yolken (ed.) 2003. Manual of Clinical Microbiology, 8th
ed. American Society for Microbiology, Washington, D.C.
16. Murray, P.R., Baron, E., Jorgensen, J.H., Landry, M.L., Pfaller, M.A. Manual of Clinical Microbiology. 9th ed. Washington
D.C.: ASM Press, 2007.
17. National Committee for Clinical Laboratory Standards, M29-A, Protection of Laboratory Workers from Instrument
Biohazards and Infectious Disease Transmitted by Blood, Body Fluids and Tissue - Approved Guideline, 1997.
18. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention,
National Institutes of Health, Office of Health and Safety, Biosafety in Microbiological and Biomedical Laboratories, 1988.
19. Winn, W.C. Jr, Allen, S.D., Janda, W.M., Koneman, E.W., Propcop, G.W., Schreckenberger, P.C., Woods, G.L.
Koneman's Color Atlas and Textbook of Diagnostic Microbiology 6th ed. Philadelphia: Lippincott Williams & Wilkins, 2006.
Use this Instructions for Use with VITEK® 2 Product No. 21347.
INDEX OF SYMBOLS

Symbol Meaning
Catalog number

In Vitro Diagnostic Medical Device

Legal Manufacturer

Temperature limitation

Use by date

Batch code

Consult Instructions for Use

Date of manufacture

Contains sufficient for <n> tests

Authorized representative in the

European Community
For US Only : Caution : US Federal
Law restricts this device to sale by
or on the order of a licensed
practitioner

Instructions for Use provided in the kit or downloadable from www.biomerieux.com/techlib

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VITEK® 2 ANC 043907- 02 - en - 2016-10

LIMITED WARRANTY
bioMérieux warrants the performance of the product for its stated intended use provided that all procedures for usage,
storage and handling, shelf life (when applicable), and precautions are strictly followed as detailed in the instructions for use
(IFU).
Except as expressly set forth above, bioMérieux hereby disclaims all warranties, including any implied warranties of
merchantability and fitness for a particular purpose or use, and disclaims all liability, whether direct, indirect or consequential,
for any use of the reagent, software, instrument and disposables (the “System”) other than as set forth in the IFU.
REVISION HISTORY TABLE
Change type categories
N/A Not applicable (First publication)
Correction Correction of documentation anomalies
Technical change Addition, revision and/or removal of information related to the product
Administrative Implementation of non-technical changes noticeable to the user
Note : Minor typographical, grammar, and formatting changes are not included
in the revision history.

Release Date Part Number Change Type Change Summary

2016-10 043907-02 Technical change • Updated content to
reflect the 8.01 Product
Information Manual

2016-05 043907-01 Administrative • Formatting changes do

not affect the fit, form, or
function of the product

Technical change • New IFU derived from

product chapter in the
Product Information
Manual
• Updated Limited
Warranty section
• Updated with RX only
information

BIOMÉRIEUX, the BIOMÉRIEUX logo, VITEK, API, Count-TACT, chromID, DensiCHEK and bioLiaison are used, pending,
and/or registered trademarks belonging to bioMérieux, or one of its subsidiaries, or one of its companies.
This product may be protected by one or more patents, see: http://www.biomerieux-usa.com/patents.
The ATCC trademark and trade name and any and all ATCC catalog numbers are trademarks of the American Type Culture
Collection.
CLSI is a trademark belonging to Clinical Laboratory and Standards Institute, Inc.
Any other name or trademark is the property of its respective owner.
©BIOMÉRIEUX 2018

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