BIOMÉRIEUX

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
VIDAS BꞏRꞏAꞏHꞏMꞏS PCT™ (PCT)
VIDAS® BꞏRꞏAꞏHꞏMꞏS PCT™ is an automated test for use on the VIDAS® family of instruments for the determination of
human procalcitonin in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay)
technique.
Used in conjunction with other laboratory findings and clinical assessments, VIDAS® B•R•A•H•M•S PCT™ aids in the risk
assessment of critically ill patients on their first day of ICU admission, for progression to severe sepsis and septic shock.
Used in conjunction with other laboratory findings and clinical assessments, VIDAS® B·R·A·H·M·S PCT™ also
aids in decision making on antibiotic therapy for patients with lower respiratory tract infections (LRTI) (including
community acquired pneumonia, exacerbation of chronic obstructive pulmonary disease, acute bronchitis) seen during
medical consultations, including at the Emergency Department.

SUMMARY AND EXPLANATION The safe reduction of antibiotic use through PCT-guided
Procalcitonin (PCT) is the prohormone of calcitonin. therapy was confirmed in an observational quality
Whereas calcitonin is only produced in the C cells of the surveillance study that considered consecutive LRTI
thyroid gland as a result of hormonal stimulus, PCT is patients, recruited without exclusion criteria, who were
secreted by different types of cells from numerous organs seen at an emergency department or a physician’s office
in response to proinflammatory stimulation, particularly (14).
bacterial stimulation (1). In certain situations (newborns, polytrauma, burns, major
Depending on the clinical background, a PCT surgery, prolonged or severe cardiogenic shock, etc.)
concentration above 0.1 ng/mL can indicate clinically PCT elevation may be independent of any infectious
relevant bacterial infection, requiring antibiotic treatment aggression. The return to normal values is usually rapid.
(2). At a PCT concentration > 0.5 ng/mL, a patient should Viral infections, allergies, autoimmune diseases and graft
be considered at risk of developing severe sepsis or rejection do not lead to a significant increase in PCT (15)
septic shock (3, 4). A localized bacterial infection can lead to a moderate
Sepsis is an excessive reaction of the immune system increase in PCT levels (2, 16).
and coagulation system to an infection (5). The diagnosis The evaluation of VIDAS® B•R•A•H•M•S PCT™ assay
and monitoring of infected patients are major problems for results must always be performed taking into
physicians. It has been proven that PCT levels increase consideration the patient’s history and the results of any
precociously, specifically in patients with a bacterial other tests performed.
infection. For laboratory diagnosis, PCT is therefore an If discrepancies are found between the laboratory findings
important marker enabling specific differentiation between and the clinical signs, additional tests should be
a bacterial infection and other causes of inflammatory performed.
reactions (2). Moreover, the resorption of the septic
PRINCIPLE
infection is accompanied by a decrease in the PCT
The assay principle combines a one-step enzyme
concentration which returns to normal with a half-life of 24
immunoassay sandwich method with a final fluorescent
hours (6, 7).
detection (ELFA).
Several randomized clinical trials have shown that the use
The Solid Phase Receptacle (SPR) serves as the solid
of procalcitonin to guide the initiation and also the duration
phase as well as the pipetting device. Reagents for the
of antibiotic treatment in patients with LRTI, significantly
assay are ready-to-use and pre-dispensed in the sealed
reduced antibiotic consumption across different LRTI
reagent strips.
diagnoses (8, 9). The randomized trials were conducted in
All of the assay steps are performed automatically by the
different settings, including primary care (10), the
instrument. The sample is transferred into the wells
Emergency Department (11) or the ICU (12). In the ED or
containing anti-procalcitonin antibodies labeled with
the primary care setting, a cut-off concentration at
alkaline phosphatase (conjugate). The sample/conjugate
0.25 ng/ml was used to either withhold or stop antibiotics
mixture is cycled in and out of the SPR device several
in LRTI patients (13, 9, 14). times. This operation enables the antigen to bind with the
The reduction of antibiotic consumption was clinically safe immunoglobulins fixed to the interior wall of the SPR
in this framework, as no higher rates of mortality or device and the conjugate to form a sandwich Unbound
treatment failure were associated with a PCT-guided components are eliminated during washing steps.
antibiotic therapy (9). Two detection steps are then performed successively.
During each step, the substrate (4-Methyl-umbelliferyl
phosphate) is cycled in and out of the SPR device. The
conjugate enzyme catalyzes the hydrolysis of this
substrate into a fluorescent product (4-Methyl-
umbelliferone), the fluorescence of which is measured at
450 nm. The intensity of the fluorescence is proportional
to the concentration of antigen present in the sample. At
the end of the assay, the results are automatically
calculated by the instrument in relation to two calibration
curves stored in memory corresponding to the two
detection steps. A fluorescence threshold value
determines the calibration curve to be used for each
sample. The results are then printed out.

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CONTENT OF THE KIT - RECONSTITUTION OF REAGENTS (60 TESTS):

60 PCT Strips (a) STR Ready-to-use.
60 PCT Solid Phase SPR Ready-to-use. Interior of SPR devices coated with mouse monoclonal anti-human
Receptacles procalcitonin immunoglobulins.
2 x 30
PCT Controls Reconstitute with 2 mL of distilled water. Wait for 5 to 10 minutes and then mix.
C1 Control (b) C1 Stable after reconstitution for 8 hours at 2-8°C, or until the expiration date on the kit
2 x 2 mL (lyophilized) at - 25  6°C. 5 freeze/thaw cycles are possible.
C2 Control (b) C2 TRIS NaCl buffer (pH 7.3) + recombinant human PCT + preservatives.
2 x 2 mL (lyophilized) MLE data indicate the acceptable range in ng/mL ("Control C1 Dose Value Range"
or "Control C2 Dose Value Range").
PCT Calibrators Reconstitute with 2 mL of distilled water. Wait for 5 to 10 minutes and then mix.
S1 Calibrator (b) S1 Stable after reconstitution for 8 hours at 2-8°C, or until the expiration date on the kit
2 x 2 mL (lyophilized) at - 25  6°C. 5 freeze/thaw cycles are possible.
S2 Calibrator (b) S2 TRIS NaCl buffer (pH 7.3) + recombinant human PCT + preservatives.
2 x 2 mL (lyophilized) MLE data indicate the concentration in ng/mL ("Calibrator (S1) Dose Value" or
"Calibrator (S2) Dose Value") and the acceptable range in "Relative Fluorescence
Value" (Calibrator (S1) RFV Range or Calibrator (S2) RFV Range).
Specifications for the factory master data required to calibrate the test:
 MLE data (Master Lot Entry) provided in the kit.
or
 MLE bar codes printed on the box label.
1 package insert provided in the kit or downloadable from www.biomerieux.com/techlib.

(a) DANGER WARNING EUH208 / H317 / H318 / P261 / P280 / P302 + P352 / P305 + P351 +
P338

(b) WARNING EUH208 / H317 / P261 / P280 / P302 + P352

Hazard statements
EUH208: Contains 2-methyl-2H-isothiazolin-3-one. May cause an allergic reaction.
H317: May cause an allergic skin reaction.
H318: Causes serious eye damage.
Precautionary statements
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P302 + P352: IF ON SKIN: Wash with plenty of soap and water.
P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing.

For further information, please refer to the Safety Data Sheet.

The SPR device The Reagent Strip

The interior of the SPR device is coated during The strip consists of 10 wells covered with a labeled foil
production with mouse monoclonal anti-human seal. The label comprises a bar code which mainly
procalcitonin immunoglobulins. Each SPR device is indicates the assay code, kit lot number and expiration
identified by the PCT code. Only remove the required date. The foil of the first well is perforated to facilitate
number of SPR devices from the pouch and carefully the introduction of the sample. The last well of each
reseal the pouch after opening. strip is a cuvette in which the fluorometric reading is
performed. The wells in the center section of the strip
contain the various reagents required for the assay.

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Description of the PCT strip

Well Reagents
1 Sample well.
2-3-4 Empty wells.
5 Conjugate: alkaline phosphatase-labeled mouse monoclonal anti-human procalcitonin
immunoglobulins + preservative (400 µL).
6 -7 - 8 TRIS NaCl Tween (pH 7.3) + preservative (600 µL).
9 Empty well.
10 Reading cuvette with substrate: 4-Methyl-umbelliferyl-phosphate (0.6 mmol/L) + diethanolamine
(DEA) (0.62 mol/L or 6.6%, pH 9.2) + 1 g/L sodium azide (300 µL).

MATERIALS AND DISPOSABLES REQUIRED BUT  After opening the kit, check that the SPR pouch is
NOT PROVIDED correctly sealed and undamaged. If not, do not use the
- Pipette with disposable tip to dispense 2 mL and 200 µL. SPR devices.
- Powderless, disposable gloves.  Carefully reseal the pouch with the desiccant inside
- For other specific materials and disposables, please after use to maintain stability of the SPR devices
refer to the Instrument User Manual. and return the complete kit to 2-8°C.
- Instrument of the VIDAS® family.  If stored according to the recommended conditions, all
components are stable until the expiration date indicated
ADDITIONAL REAGENT on the label. Refer to the kit composition table for
special storage conditions.
- Serum free (ref. 66 581)
SPECIMENS
WARNINGS AND PRECAUTIONS
 For in vitro diagnostic use only. Specimen type and collection
 For professional use only. Human serum or plasma (lithium heparin).
 The kit contains products of animal origin. Certified Since EDTA causes a decrease in the values measured,
knowledge of the origin and/or sanitary state of the plasma collected on EDTA should not be used.
animals does not totally guarantee the absence of
transmissible pathogenic agents. It is therefore For a given patient, the PCT assays must be
recommended that these products be treated as performed on the same type of sample tube.
potentially infectious, and handled observing the usual Specimen Type
safety precautions (do not ingest or inhale). - Dry tubes: wait for samples to coagulate and centrifuge
 Do not use the SPR devices if the pouch is pierced. according to the tube manufacturer’s recommendations
 Do not use visibly deteriorated STRs (damaged foil or to eliminate fibrin.
plastic). - Other tubes: follow the tube manufacturer’s
 Do not use reagents after the expiration date indicated recommendations for use.
on the kit label. - Frozen-stored samples: after thawing, these samples
 Do not mix reagents (or disposables) from different lots. must be clarified by centrifuging before testing.
 Kit reagents contain sodium azide which can react with
lead or copper plumbing to form explosive metal azides. Note: Blood sampling tube results may vary from one
If any liquid containing sodium azide is disposed of in manufacturer to another depending on the materials and
the plumbing system, drains should be flushed with additives used.
water to avoid build-up. It is the responsibility of each laboratory to validate the
 Use powderless gloves, as powder has been reported type of sample tube used and to follow the manufacturer’s
to cause false results for certain enzyme immunoassay recommendations for use.
tests.
Sample preparation
 Refer to the hazard statements "H" and the
precautionary statements "P" indicated above. Follow the tube manufacturer’s recommendations for use.
 Spills should be wiped up thoroughly after treatment The pre-analytical step, including the preparation of blood
with liquid detergent or a solution of household bleach samples, is an essential first step when performing
containing at least 0.5% sodium hypochlorite. See the medical analyses. In accordance with Good Laboratory
User Manual for cleaning spills on or in the instrument. Practice, this step is performed under the responsibility of
Do not autoclave solutions containing bleach. the laboratory manager.
 The instrument should be regularly cleaned and Insufficient clot time can result in the formation of fibrin
decontaminated (see the User Manual). with micro-clots that are invisible to the naked eye. The
presence of fibrin, red blood cells, or suspended particles
STORAGE CONDITIONS can lead to erroneous results.
 Store the VIDAS® BꞏRꞏAꞏHꞏMꞏS PCT™ kit at 2-8°C. Samples containing suspended fibrin particles or
 Do not freeze reagents, with the exception of erythrocyte stroma should be centrifuged before testing.
calibrators and controls after reconstitution.
For serum specimens, ensure that complete clot
 Store all unused reagents at 2-8°C.
formation has taken place prior to centrifugation.

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Some specimens, especially those from patients receiving minor variations in assay signal throughout the shelf-life of
anticoagulant or thrombolytic therapy, may exhibit the kit.
increased clotting times. The calibrators identified by S1 and S2, must be tested
in duplicate (see User Manual) in the same run. The
Sample stability
calibration values must be within the set RFV (Relative
Samples separated from the clot can be stored at 2-8°C in Fluorescence Value). If this is not the case, recalibrate
stoppered tubes for up to 48 hours; if longer storage is using S1 and S2.
required, freeze the sera or plasma at -25  6°C. Six-
month storage of frozen samples does not affect the Procedure
quality of results. Three freeze/thaw cycles have been 1. Remove the required reagents from the
validated. refrigerator.
Test sample volumes less than 200 µL 2. Use one "PCT" strip and one "PCT" SPR device for
each sample, control or calibrator to be tested. Make
Test sample volumes between 50 µL and 200 µL can be
sure the storage pouch has been carefully
tested after performing a manual dilution up to 1/4
resealed after the required SPR devices have been
(1 volume of test sample + 3 volumes of Serum Free
removed.
reagent (ref. 66 581)) and no more than two hours after
dilution. 3. The test is identified by the "PCT" code on the
instrument. The calibrators must be identified by "S1"
Sample-related interferences and "S2", and tested in duplicate. If the controls need
None of the following factors have been found to to be tested, they should be identified by "C1" and
significantly influence this assay: "C2" and tested singly.
- hemolysis (after spiking samples with hemoglobin: up to 4. Mix the calibrators and controls using a vortex-type
347 µmol/L (monomer)), mixer.
- lipemia (after spiking samples with lipids, up to 30 g/L
5. To obtain optimum results, refer to all the paragraphs
equivalent in triglycerides),
in the SPECIMENS section.
- bilirubinemia (after spiking samples with bilirubin: up to
574 µmol/L). 6. Before pipetting, ensure that samples, calibrators and
However, it is recommended not to use samples that are controls are free of bubbles.
clearly hemolyzed, lipemic or icteric and, if possible, to 7. For this test, the test portion of the calibrators,
collect a new sample. controls and samples is 200 µL.
8. Insert the SPR devices and the strips into the
INSTRUCTIONS FOR USE
instrument. Check to make sure the color labels with
For complete instructions, see the Instrument User the assay code on the SPR devices and the Reagent
Manual. Strips match.
Reading VIDAS® Protocol Test Change (PTC) data and 9. Initiate the assay immediately. All the assay steps
MLE data are performed automatically by the instrument.
When using the assay for the first time:
10. Reclose the vials and return them to the required
With the external instrument barcode reader, temperature after pipetting.
1. Scan the PTC barcode(s) at the end of the package 11. The assay will be completed within approximately
insert or downloadable from 20 minutes. After the assay is completed, remove the
www.biomerieux.com/techlib. This reading allows SPR devices and strips from the instrument.
VIDAS® PTC protocol data to be transferred to the 12. Dispose of the used SPR devices and strips into an
instrument software for its update. appropriate recipient.
2. Scan the MLE data on the box label.
RESULTS AND INTERPRETATION
Note: If the MLE data have been read before the
VIDAS® PTC protocol, read the MLE data again. Once the assay is completed, results are analyzed
automatically by the computer using two calibration
When opening a new lot of reagents: curves which are stored by the instrument; the
Enter the specifications (or factory master data) into the concentrations are expressed in ng/mL.
instrument using the master lot entry (MLE) data. As no international standard is available, VIDAS®
If this operation is not performed before initiating the B•R•A•H•M•S PCT™ is calibrated against an internal
tests, the instrument will not be able to print results. panel of human sera with known procalcitonin
Note: the master lot data need only to be entered concentrations. In case of patient follow-up, it is
once for each lot. recommended to use the same PCT assay technique.
Samples with procalcitonin concentrations > 200 ng/mL
It is possible to enter MLE data manually or should be retested after dilution by 1/10 (1 volume of
automatically depending on the instrument (refer to the sample + 9 volumes of PCT negative sample or Serum
VIDAS® User Manual). Free reagent (ref. 66 581)). The final result should take
into account the original dilution factor.
Calibration
Calibration, using the two calibrators provided in the kit,
must be performed each time a new lot of reagents is
opened, after the master lot data have been entered, and
then every 28 days. This operation provides instrument-
specific calibration curves and compensates for possible

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Special case of a sample volume < 200 µL: If the dilution factor has not been entered when the Work
If the result obtained after dilution is below the measuring List was created (see User Manual), multiply the result by
range for the test (0.05 ng/mL) then the VIDAS® the dilution factor to obtain the sample concentration.
instrument will report an "INVALID" result with the mention Interpretation of test results should be made taking into
"over-diluted". The final result cannot be calculated and consideration the patient's history, and the results of any
should be reported as less than (0.05 ng/mL x dilution other tests performed.
factor). In this case, a sample which is tested with a
dilution at 1/4 should be reported as less than 0.2 ng/mL
(0.2 = 0.05 x 4).

QUALITY CONTROL
Two controls are included in each VIDAS® B•R•A•H•M•S PCT™ kit. These controls must be performed immediately after
opening a new kit to ensure that reagent performance has not been altered. Each calibration must also be checked using
these controls. The instrument will only be able to check the control values if they are identified by C1 and C2.
Results cannot be validated if the control values deviate from the expected values.
Note
It is the responsibility of the user to perform Quality Control in accordance with any applicable local regulations.

LIMITATIONS OF THE METHOD

Interference may be encountered with certain samples containing antibodies directed against reagent components. For
this reason, assay results should be interpreted taking into consideration the patient's history, and the results of any
other tests performed.
RANGE OF EXPECTED VALUES
- Risk assessment for progression to severe sepsis and septic shock
In agreement with the literature (3, 4), the results obtained with VIDAS® B•R•A•H•M•S PCT™ during a study performed
on patients admitted to intensive care units (refer to the "Clinical performance" section) are as follows:
- a concentration < 0.5 ng/mL represents a low risk of severe sepsis and/or septic shock.
- a concentration > 2 ng/mL represents a high risk of severe sepsis and/or septic shock.
Nevertheless, concentrations < 0.5 ng/mL do not exclude an infection, on account of localized infections (without
systemic signs) which can be associated with such low concentrations, or a systemic infection in its initial stages
(< 6 hours). Furthermore, increased procalcitonin can occur without infection. PCT concentrations between 0.5 and
2.0 ng/mL should be interpreted taking into account the patient’s history. It is recommended to retest PCT within 6-24
hours if any concentrations < 2 ng/mL are obtained.

- Decision making on antibiotic therapy for patients with lower respiratory tract infections
In agreement with the literature (8, 9, 10, 11, 12, 13), and validated using VIDAS® B•R•A•H•M•S PCT™ (14),
recommended cut-off values are as follows:

PCT concentration Analysis / Recommendation Note

< 0.10 ng/mL Indicates absence of bacterial  If antibiotics are withheld, repeat PCT measurement
infection. within 6-24 hours (also in outpatients if symptoms
Antibiotic therapy strongly persist/worsen).
discouraged.
 Antibiotic therapy should be considered for:
0.10-0.25 ng/mL Bacterial infection unlikely.
o Respiratory or hemodynamic instability, severe
Antibiotic therapy discouraged.
comorbidities, ICU admission
o PCT <0.1 ng/mL: CAP with PSI V or CURB-
65>3, COPD with GOLD IV
o PCT 0.1-0.25 ng/mL: CAP with PSI IV & V or
CURB-65>2, COPD with GOLD III & IV
0.26-0.50 ng/mL Bacterial infection is possible.  Follow up samples can be tested at regular intervals
Antibiotic therapy recommended. and antibiotic therapy may be discontinued using the
same cut-off values per this table.
> 0.50 ng/mL Suggestive of presence of
bacterial infection. Antibiotic  If PCT remains high, consider treatment failure
therapy strongly recommended.

- CAP: Community-Acquired Pneumonia

- PSI: Pneumonia Severity Index
- CURB-65: Confusion – Urea – Respiratory Rate – Blood pressure – age > 65 years
- COPD: Chronic Obstructive Pulmonary Disease
- GOLD: Global initiative for chronic Obstructive Lung Disease

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PERFORMANCE
Studies performed using VIDAS® BꞏRꞏAꞏHꞏMꞏS PCT™ gave the following results:
Measurement range
The VIDAS® BꞏRꞏAꞏHꞏMꞏS PCT™ assay measurement range is 0.05-200 ng/mL.
Detection limits
The Limit of Blank (LoB), the Limit of Detection (LoD) and the Limit of Quantitation (LoQ) were determined according to
the CLSI® EP17-A2 recommendations:
Limit of Blank (LoB) 0.01 ng /mL
Limit of Detection (LoD) 0.03 ng /mL
Limit of Quantitation (LoQ) 0.05 ng /mL
The Limit of Quantitation (LoQ) is the lowest concentration of PCT measured with a within-site precision of 20% CV.
Hook effect
No hook effect was found up to procalcitonin concentrations of 2 600 ng/mL.
Normal values
These results are given as a guide; it is recommended that each laboratory establish its own reference values from a
rigorously selected population.
A study was performed using the VIDAS® B•R•A•H•M•S PCT™ test on serum samples from apparently healthy male
(N=98) and female (N=102) individuals. The normal values corresponding to the 95th and 99th percentiles were
respectively found at < 0.05 ng/mL and at 0.09 ng/mL.
Precision
A precision study was performed according to the recommendations of CLSI® document EP5-A3.
Nine samples were tested in duplicate in 2 runs per day, over 20 days using 3 VIDAS® instruments installed in 3
laboratories (N=240 values for each sample).
Two reagent lots were used: 10 days of tests and 2 calibrations were performed for each lot (5 test days per calibration).
The repeatability, within-laboratory precision and reproducibility/total precision (between-laboratory precision) were
estimated for each sample and are reported in the following table:

Within-laboratory ReproducibilityTotal
Repeatability
Mean Precision precision
Sample N Concentration
(ng/mL) Standard Standard Standard
deviation CV (%) deviation CV (%) deviation CV (%)
(ng/mL) (ng/mL) (ng/mL)
Sample 1 240 0.12 0.011 9.4% 0.017 14.7% 0.017 14.7%
Sample 2 240 0.15 0.010 6.4% 0.019 12.5% 0.019 12.5%
Sample 3 240 0.20 0.010 5.1% 0.017 8.3% 0.017 8.3%
Sample 4 240 0.53 0.013 2.4% 0.023 4.3% 0.023 4.3%
Sample 5 240 2.12 0.027 1.3% 0.079 3.7% 0.079 3.7%
Sample 6 240 23.09 0.501 2.2% 1.067 4.6% 1.067 4.6%
Sample 7 240 92.17 3.099 3.4% 7.252 7.9% 7.252 7.9%
Sample 8 240 128.37 5.155 4.0% 12.578 9.8% 12.578 9.8%
Sample 9 240 162.79 7.233 4.4% 18.934 11.6% 18.934 11.6%

Specificity
The following compounds, tested at the concentrations indicated in the table, do not affect the VIDAS® B•R•A•H•M•S
PCT™ assay.
Tested compound Tested concentration
Protein (albumin) 4 g/dL
Human Calcitonin 60 ng/mL
Human Katacalcin 10 ng/mL
Human a-CGRP* 10 µg/mL
Human b-CGRP* 10 µg/mL
*Calcitonin Gene Related Peptide

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Drug interference
The following drugs, at the concentrations indicated in the table, do not affect the VIDAS® B•R•A•H•M•S PCT™ assay:

Tested drug Tested concentration

Acetominophen (paracetamol) 1 324 µmol/L
Acetylsalicylic Acid 3.62 mmol/L
Alcohol 86.8 mmol/L
Amoxicillin 206 µmol/L
Ampicillin 152 µmol/L
Azithromycin 15.3 µmol/L
Beclometasone dipropionate 1.00 µg/mL
Caffeine 308 µmol/L
Cefotaxime 673 µmol/L
Ceftriaxone 1 416 µmol/L
Celecoxib 240 µg/mL
Cetirizine HCl 7.71 µmol/L
Cromolyn 24 µg/mL
Dextromethorphan 3.70 µmol/L
Dopamine 5.87 µmol/L
Dobutamine 1 500 ng/mL
Epinephrine (adrenaline) 1.8 µg/mL
Fluticasone 0.30 µg/mL
Formoterol 29 ng/mL
Furosemide 181 µmol/L
Heparin 3 000 IU/mL
Ibuprofen 2 425 µmol/L
Imipenem 180 µg/mL
Levoflaxacin 48.6 µmol/L
Linezolid 480 µg/mL
Loratadine 0.78 µmol/L
Naproxen 2 170 µmol/L
Nicotine 6.2 µmol/L
Noradrenaline 2.1 ng/mL
Oxymetazoline HCl 90 ng/mL
Phenylephrine 180 ng/mL
Prednisolone 8.31 µmol/L
Salmeterol 60 ng/mL
Theophylline 222 µmol/L
Tiotropium 22 ng/mL
Vancomycin 69 µmol/L

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Accuracy
The test linearity was studied according to a procedure taken from the CLSI® EP6-A guideline. The test is linear over the
complete measurement range.
Three samples were diluted in a PCT-negative serum pool and tested in triplicate. The ratio of the mean concentration
measured over the expected mean concentration is expressed as a mean recovery percentage.
Expected mean Measured mean Mean recovery percentage
Samples Dilution factor
concentration (ng/mL) concentration (ng/mL) (%)
1 1/1 137.07 137.07 100.0
1/2 68.54 71.54 104.4
1/3 45.69 49.56 108.5
1/4 34.27 37.26 108.7
1/8 17.13 19.50 113.8
1/16 8.57 8.75 102.2
1/20 6.85 7.73 112.8
2 1/1 38.67 38.67 100.0
1/2 19.34 19.75 102.1
1/3 12.89 13.90 107.8
1/4 9.67 9.79 101.3
1/8 4.83 4.96 102.5
1/16 2.42 2.26 93.3
1/20 1.93 1.85 95.7
3 1/1 7.58 7.58 100.0
1/2 3.79 4.17 110.1
1/3 2.53 2.70 107.0
1/4 1.90 1.98 104.7
1/8 0.95 0.94 99.2
1/16 0.47 0.51 108.4
1/20 0.38 0.37 98.5

Concordance with the B•R•A•H•M•S PCT LIA method

A concordance study between VIDAS® B•R•A•H•M•S PCT™ and B•R•A•H•M•S PCT LIA was performed using 204
samples with cut-off values at 0.5 ng/mL and 2 ng/mL.

BꞏRꞏAꞏHꞏMꞏS PCT LIA

VIDAS® BꞏRꞏAꞏHꞏMꞏS PCT™
≤ 0.5 ng/mL > 0.5 ng/mL Total

≤ 0.5 ng/mL 74 1 75

> 0.5 ng/mL 5 124 129

Total 79 125 204

BꞏRꞏAꞏHꞏMꞏS PCT LIA

VIDAS® BꞏRꞏAꞏHꞏMꞏS PCT™
≤ 2 ng/mL > 2 ng/mL Total
≤ 2 ng/mL 109 4 113
> 2 ng/mL 8 83 91
Total 117 87 204
The percentages of concordance between the 2 techniques for the cut-off values at 0.5 and 2 ng/mL are respectively
97.1% and 94.1%.

Clinical Performance
 Risk assessment for progression to severe sepsis and septic shock
A study performed at four (4) sites (2 in France and 2 in the USA) determined the clinical performance of the VIDAS®
B•R•A•H•M•S PCT™ assay. This study included 229 patients (141 males and 88 females), who were consecutively
admitted to the medical intensive care unit (MICU). The data represents first day admission testing. Patients admitted for
trauma, surgery, burns, or prolonged or severe cardiogenic shock were excluded from the study.
Based on criteria from the consensus conference of the American College of Chest Physicians/Society of Critical Care
Medicine (5), patients were classified into 5 categories: no infection, SIRS (Systemic Inflammatory Response Syndrome),
sepsis, severe sepsis and septic shock. The classification was reviewed by an independent expert.

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The number, range and mean age in each category were as follows:
- no infection: 27 patients aged between 22 and 92 years (mean 64.4 years)
- SIRS: 62 patients aged between 18 and 87 years (mean 59.0 years)
- sepsis: 42 patients aged between 21 and 92 years (mean 64.2 years)
- severe sepsis: 48 patients aged between 19 and 89 years (mean 66.3 years)
- septic shock: 50 patients aged between 33 and 88 years (mean 68.2 years)

PCT values for the groups of patients with no infection or SIRS or sepsis versus severe sepsis or septic shock with cut-
off values at 0.5 ng/mL and 2.0 ng/mL are shown in the tables below:
- Results obtained with a cut-off value at 0.5 ng/mL:
No infection/SIRS/sepsis Severe sepsis/septic shock Total
PCT ≤ 0.5 ng/mL 88 3 91
PCT > 0.5 ng/mL 43 95 138
Total 131 98 229
- Results obtained with a cut-off value at 2 ng/mL:
No infection/SIRS/sepsis Severe sepsis/septic shock Total
PCT ≤ 2 ng/mL 115 19 134
PCT > 2 ng/mL 16 79 95
Total 131 98 229

 Decision making on antibiotic therapy for patients with lower respiratory tract infections
A clinical study (14) established clinical performance data for the VIDAS® B.R.A.H.M.S PCT™ assay in terms of decision
making on antibiotic therapy for patients with lower respiratory tract infections.
This study shows that the duration of antibiotic therapy is significantly reduced (from 7.4 to 5.9 days) compared to
medical care that does not include the evaluation of PCT concentrations (difference of -1.51 days; 95% confidence
interval [−2.04 ;−0.98]; p < 0.01). The study population was composed of patients with community-acquired pneumonia,
exacerbation of chronic obstructive pulmonary disease or acute bronchitis.
Furthermore, no increase in adverse medical outcomes (relapse, hospitalization, side effects of antibiotic therapy,
and/or mortality) is associated with withholding antibiotic therapy for patients with low PCT values (≤ 0.25 ng/mL) on
hospital admission, and with stopping antibiotic therapy.

WASTE DISPOSAL
Dispose of used or unused reagents as well as any other contaminated disposable materials following procedures for
infectious or potentially infectious products.
It is the responsibility of each laboratory to handle waste and effluents produced according to their nature and degree of
hazardousness and to treat and dispose of them (or have them treated and disposed of) in accordance with any
applicable regulations.

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13. STOLZ D, CHRIST-CRAIN M, et al. Diagnostic value of

LITERATURE REFERENCES signs, symptoms and laboratory values in lower respiratory
1. DANDONA P , NIX D, et al. Procalcitonin increase after tract infection. SwissMedWkly. 2006;136:434-440.
endotoxin injection in normal subjects, J Clin Endocrinol 14. ALBRICH WC, DUSEMUND F, et al. Effectiveness and
Metab. 1994; 79: 1605-1608. Safety of Procalcitonin-Guided Antibiotic Therapy in Lower
2. CHRIST-CRAIN M, JACCARD-STOLZ D, et al. Effect of Respiratory Tract Infections in “Real Life”. Arch Intern
procalcitonin-guided treatment on antibiotic use and Med. 2012;172:715-722.
outcome in lower respiratory tract infections : cluster- 15. MEISNER M. Procalcitonin (PCT) – A new, innovative
randomised single-blinded intervention trial. Lancet 2004; infection parameter. Biochemical and clinical aspects.
363: 600-607. Thieme Stuttgart, New York 2000, ISBN: 3-13-105503-0
3. MULLER B, BECKER KL, et al. Calcitonin precursors are 16. CHRIST-CRAIN M, MULLER B. Procalcitonin in bacterial
reliable markers of sepsis in medical intensive care unit. infections--hype, hope, more or less? Swiss Med Wkly
Crit. Care Med. 2000;28: 977-983. 2005;135:451-460.
4. HARBARTH S, HOLECKOVA K, et al. Diagnostic value of 17. SCHUETZ P, ALBRICH W, et al. Procalcitonin for
procalcitonin, interleukin-6 and interleukin-8 in critically ill guidance of antibiotic therapy. Expert Rev Anti Infect Ther
patients admitted with suspected sepsis. Am J Respir Crit 2010;8:575-587.
Care Med. 2001;164: 396-402.
5. American College of Chest Physicians/Society of Critical INDEX OF SYMBOLS
Care Medicine: Definitions for sepsis and organ failure and
guidelines for the use of innovative therapies in sepsis. Crit Symbol Meaning
Care Med 1992; 20: 864-874.
6. LUYT CE, GUERIN V, et al. Procalcitonin kinetics as a Catalog number
prognostic marker of ventilator-associated pneumonia. Am
J Respir Crit Care Med 2005;171: 48-53.
7. BRUNKHORST FM, HEINZ U, et al. Kinetics of In Vitro Diagnostic Medical Device
procalcitonin in iatrogenic sepsis. Intensive Care Med.
1998; 24:888-892.
Manufacturer
8. SCHUETZ P, CHRIST-CRAIN M, et al. Effect of
procalcitonin-based guidelines vs standard guidelines on
antibiotic use in lower respiratory tract infections: the
ProHOSP randomized controlled trial. JAMA Temperature limit
2009;302:1059-1066.
9. SCHUETZ P, MULLER B, et al. Procalcitonin to initiate or
discontinue antibiotics in acute respiratory tract infections. Use by date
Cochrane Database Syst Rev. 2012;9:CD007498.
10. BURKHARDT O, EWIG S, et al. Procalcitonin guidance Batch code
and reduction of antibiotic use in acute respiratory tract
infection. Eur Respir J. 2010;36:601-7. Consult Instructions for Use
11. CHRIST-CRAIN M, JACCARD-STOLZ D, et al. Effect of
Procalcitonin-guided treatment on antibiotic use and
outcome in lower respiratory tract infections: cluster- Contains sufficient for <n> tests
randomised, single-blinded intervention trial. Lancet
2004;363:600-7.
12. BOUADMA L, LUYT CE, et al. Use of procalcitonin to Date of manufacture
reduce patients' exposure to antibiotics in intensive care
units (PRORATA trial): a multicentre randomised
controlled trial. Lancet 2010; 375:463-474.

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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
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

SUMMARY AND EXPLANATION
CONTENT OF THE KIT - RECONSTITUTION
OF REAGENTS (60 TESTS):
MATERIALS AND DISPOSABLES REQUIRED
BUT NOT PROVIDED
SPECIMENS
2016/11 13207H Technical change INSTRUCTIONS FOR USE
RESULTS AND INTERPRETATION
QUALITY CONTROL
RANGE OF EXPECTED VALUES
PERFORMANCE
LITERATURE REFERENCES
LIMITED WARRANTY
CONTENT OF THE KIT - RECONSTITUTION
2019/07 045234 - 02 Technical change OF REAGENTS (60 TESTS)
WARNINGS AND PRECAUTIONS

Reagent developed in collaboration with B•R•A•H•M•S

For users in the European Union (Regulation (EU) 2017/746) and in countries with similar requirements: Should a
serious incident occur during the use of this device or as a result of its use, please report it to the manufacturer
and/or their authorized representative as well as to your national authority.
SSP (Summary of Safety and Performance) location after the launch of the European Database on Medical
Devices/Eudamed: https://ec.europa.eu/tools/eudamed.
BIOMERIEUX, the BIOMERIEUX logo, VIDAS and SPR are used, pending, and/or registered trademarks belonging to
bioMérieux, or one of its subsidiaries, or one of its companies.
B•R•A•H•M•S PCT™ is the property of Thermo Fisher Scientific Inc and its subsidiaries.
CLSI is a trademark belonging to Clinical Laboratory and Standards Institute, Inc.
Any other name or trademark is the property of its respective owner.

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