minividas immunoassay system manual 2

mini VIDAS Essentials-Version 001-15

Essentials

mini VIDAS Essentials-Version 001-15 2

Table of Contents

Main Menu 3

System Overview 3

Sample Handling 4Pre-analytical step

Calibration 5

MLE Card 6

Calibration 7

Sample Identification 9from Status Screen

Run Samples 10

Result interpretation 11

Trouble Shooting 12 - 13

Package Insert 14

Maintenance 15 - 17

How to use a Pipette : 18Patient Sample

How to use a Pipette : Standard 19& Control Reconstitution

How to calculate centrifugation 20speed

TPSA 21 - 24

miniVIDAS Description PAGE

Routine Use PAGE

More on miniVIDAS PAGE

TPSA on mini VIDAS PAGE

Pipetting and Centrifugation PAGE

Protocol Update 8


1

2

3

4

5

6

Sample External Barcode reader

Integrated PC with Touch Pad

Strip loading (12 positions)

SPR loading position

Integrated Thermal Printer

1

2

3

4

5

6SPR block LedLed off : Available section. Led on (green) : Section in use

Touch Pad : key functions

1

2

3

4

5

To start an analysis as soon as SPR, strips and samples are in position.

To know the status of sections A & B and temperature of SPR and Strip areas.

To read the Master Lot card for any new parameter or new assay lot.

Direct access to stored results for validation, print or reprint of assay list .

Configuration of the instrument (e.g: unit, date & time, user ID, language, printer, barcode wand).

Main MenuInstrum

ent useInstrum

ent useSystem Overview

Utility Menu 5

Start Section 1

Status Screen 2

Master Lot Menu 3

Result Menu 4

To erase a data entry

To go back to the previous screen

Press once : it will display errorsPress twice : to print out the screen

The "ENTER" key to validate data

To move the cursor on certain screensTo show a 2nd or 3rd screen


The pre-analytical step is essential when performing medical analyses. In conformity with Good Laboratory Practices, this step is the responsibility of the Laboratory Manager even if sample collection is delocalized.

The presence of fibrin or suspended particles may lead to erroneous results, even when heparinized sample tubes are used. This fibrin can sometimes be in micro-clot format and invisible to the naked eye.

• Use the correct sample volume to ensure optimal blood/additive ratio.

• Homogenize the tube as soon as the sample has been collected by slowly turning it upside down.

• The air bubble must move from one end of the tube to the other.

• It is important to turn the tube upside down for the required number of turns (from 4 to10 depending on the tube reference)

Clot formation and retraction time• Respect the recommended time.• It is the responsibility of each laboratory

to validate the type of sample tube used and to follow the manufacturer’s recommendations for use.

• Maintain the tubes vertically throughout the coagulation phase.

Follow the centrifugation conditions of speed, duration and temperature.

The WHO recommendations are :• Serum: at least 1500g for 10 min.• Plasma: at least 2500g for 10 min.• Temperature : < 30°C.

All frozen tubes as well as tubes which have been shaken or withresuspended constituents after centrifugation, must be recentrifuged before starting the analysis (risk of interference with results or needle clogging)

How to calculate the centrifugation speedin rpm or g ?

The size of the rotor and operational speed (RPM) determines the RCF (xg).

More information on

Page

And on the web site :

www.djblabcare.co.uk

21

How to handle samples Pre-analytical stepInstrum

ent use Instrum

ent use


Is it a new lot ?

NO YES

See

See

• When to calibrate ?• When opening a new kit or new lot.• Every 14 or 28 days (dependent on the parameter – see package insert).

• How to know if a new calibration is needed?

• The mini VIDAS will give you a message.• Check in the Calibration Menu.

• Technical points to respect • Type of diluent for Standard &

Control reconstitution.• Volume of reconstitution.• Let stabilize (see time in the

specific package insert).• Proper mixing before pipetting in

the strip.• Proper storage after reconstitution.• Never mix kit components from

different kits or lots.

Refer to the package insert of each test.

If control values are out of the expected range, results

can not be validated !

6

7

How to perform a calibrationInstrum

ent use Instrum

ent use

1 – Read the MLE card

2 – Run Standards (S)

& Controls (C)

In case of a new parameter :

Update the assay protocol See 8

17

Every 14 days or 28 days

(depending on parameters)


Insert MLE card in the card-holder

Put the card in the direction of the arrow in the card holder.

How to read an MLE card

Insert the card holder into an available section

Read MLE card

Check MLE card and printed data correspondence

At the end of the reading :

the MLE card is automatically printed.

the screen returns to the MasterLot Menu.

=

Be sure to insert the plastic holder inside the grooves of the section.

DO NOT fold the MLE card

Instrument use

Instrument use

1

2

3

4

up

down

Start Section

Status Screen

Master Lot Menu

Results Menu

Utility Menu

B

A Available

Display temperatures

Available


Start

Section B1

2

3

4

5

6

HCG

HCG

HCG

HCG

HCG

S1

S1

C1

100

951201001 GP

951201043 MD

100

Prepare Status ScreenStart Section

Status Screen

Master Lot Menu

Results Menu

Utility Menu

B

A Available


Available

SPosition B1

C

Assay

Dilution

Sample ID

Enter Standardnumber (1-9)

Standards

Controls

S1 (X 2 or 3)

(refer to package insert)

1

2

C1 or C1+C2(+C3)(refer to package insert)

Load the reagents and samples

Run the analysis

Interpret the results

Start

Section B1

2

3

4

5

6

HCG

HCG

HCG

HCG

HCG

S1

S1

C1

100

951201001 GP

951201043 MD

100

1 - Load SPR 1st

2 - Load Strips

Example of a « Load Help Screen »

• Check correspondence of color dots.

See p

If control values are out of the

expected range, results cannot be

validated.

• Always start by preparing the status screen before loading reagents.

• The number of Standards and Controls needed will depend on the assay.

Always refer to the package insert.

• Volume to pipette depends on the reagent:

Refer to package insert.

• Mix S and C before pipeting.

Remove reagents from the fridge

11

+2–8°C

S1

C1

How to run the Standards (S) and Controls (C) for calibrationInstrum

ent use Instrum

ent use

- ONLY remove the necessary number of tests from kit box- Return the remaining kit materials to 2 –8°C- Leave tests sit 30 min at room temperature before use

or

1

1

2

3

4

5

3 – Pipette the Standard(s) and Controls

1

Type positionnumbers on key board

SPosition B3

C

Assay

Dilution

Sample ID

Enter Controlnumber (1-3)

Start

Section B123

4

5

6

Start

Section B12

3

4

5

6


How to update a protocol

At the end of the reading :

The Assay Update Report will automatically print.

Respect the reading order.

Instrument use

Instrument use

1

2

3

Start Section

Status Screen

Master Lot Menu

Results Menu

Utility Menu

See the protocol barcode

Package insert

On last page:

Open the package insert

Read the barcode

Read the barcode

1

CautionAlways read the protocol barcode before reading the MLE card

> 5 cm

Up and down scan

+ BIPGreen LED = reading complete


Start Section

Status Screen

Master Lot Menu

Results Menu

Utility Menu

B

A Available


Available

Start

Section B12

3

4

5

6


For each sample position :

Type positionnumbers on key board.

Enter Sample IDby selecting letters

with the arrow keys and/or numbers with the key pad.

• 12 numeric characters maximum.

• Press the arrow keys to select the appropriate character.

SPosition B3

C

Assay

Dilution

Sample ID

951201001 GP

HCG

1:100

SPosition B1

C

Assay

Dilution

Sample ID

SPosition B3

C

Assay

Dilution

Sample ID

In case of dilution :Only for quantitative tests.

SPosition B3

C

Test

Dilution

ID échantillon

951201001 GP

CEA

ClrDilution

Min: 1Max: 999

100 SPosition B3

C

Assay

Dilution

Sample ID

951201001 GP

CEA

1:100

Load Help screenAfter identification of all samples :

How to identify samples in the status screenInstrum

ent use Instrum

ent use

1

A4 IDClr

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

95

951201001 GP

VAN

- . / # ! + : ( )

Position B3

Start

Section B12

3

4

5

6

ANNA

951201043 GP

LEO

992346981 SH


Prepare Status Screen

Load reagents and samples

Run the analysis

Interpret results

1 - Load SPR 1st

2 - Load Strips

Example of a « Load Help Screen »• Check correspondence

of color dots.

See p If controls values are out of the expected range, results cannot be validated.


• Volume to pipette depends on the reagent

see package insert.

See p

Is there a valid calibration ?

Yes NoCreate calibration first

See pRemove reagents from fridge

- ONLY remove the necessary number of tests from kit box.- Return the remaining kit reagents to 2 –8°C.- Allow necessary reagents to sit 30 min at room temperature

before use.

7

9

11

+2–8°C

How to run samplesInstrum

ent use Instrum

ent use 1

2

3

4

5

3 - Pipette sample

Start

Section A12

3

4

5

6

HCGHCG

HCG

HCG

HCG

S1S1

C1

100

951201001 GP

951201043 MD

100 992346981 SH

Start

Section A12

3

4

5

6

HCGHCG

HCG

HCG

HCG

S1S1

C1

100

951201001 GP

951201043 MD

100 992346981 SH


m i n i Vidas Report

Ferritin (FER)

Section : A Completed: 15:14:29 18Jul08Tech: OLGAFerritin (FER)Ver: R5.3.0Lot#: 090204-0

Standard used:Completed: 15:14:29 18Jul08RFV = 4034

Position :B1 Standard 1Background: 166 RFV: 4034

Note: Std. run in singlicate.~ - Low control.# - Low RFV.d - Sample over-diluted.

Position :B2 Standard 1Background: 158 RFV: -1#

Position :B3 Control 1Background: 163 RFV: -3Result: < 1,50 ng/ml ~Position :B4Sample ID: 123456Background: 158 RFV: 10280Result: > 1200 ng/mlPosition :B5Sample ID: 741852Background: 161 RFV: 240Result: 2243.05 ng/mlDilution: 1:100

Position :B6Sample ID: 456789Background: 159 RFV: 2Result: INVALID dDilution: 1:100

BIOMERIEUX

Completed: 16:07:49 07jan09Tech : TOM

mini Vidas Report

Toxo IgM (TXM)

Section : A BIOMERIEUX

Ver: R5.3.0Lot#: 090225-0

Standard used:Completed: 10:57:23 02jan09RFV =3396

Position : A2Sample ID: 990412Background: 105 RFV:94VT:0.02 Result:Negative

TV Negative < 0.55TV Equivocal >= 0.55 to < 0.65TV Positive >= 0.65

Position : A1Sample ID: 12345Background: 101 RFV:3496TV:1.02 Result:Positive

Potential ErrorMessages

Patient Results

Cslibration Information

Date of completion

Qualitative test Quantitative testGives an interpretation of

positive, negative or equivocal

Gives a quantity

How to interpret resultsInstrum

ent use Instrum

ent use

Kit lot number

Interpretation of qualitative test


Troubleshooting 1/2

Bad MLE data1. Check the Mini-VIDAS version (must be the latest version). 2. Check the good position of the MLE card and repeat automatic reading. 3. If still MLE data bad: enter the MLE card barcodes manually:

Errorcode: 2073Time: 16:48:56 29Jun95

Master lot data bad

+ BipMaster Lot

clr6 / 16

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z +

Prev.

Bad• Clear “bad”

Numbers lettersØ ≠ O1 ≠ I

Bad barcode

Issues Solutions

• Enter manually the 8 alphanumeric digit barcode (on the strip) with the key pad.

• Press twice,and select “Restart”.

Press to stop any alarmand access the Solutions’ menu.

?

Substrate error1. Check the last cuvette on the strip and restart2. If the error persists: do not use this strip use a new strip

For assistance please call bioMérieux

Technical Support.

Instrument use

Instrument use

1

2

3Section A ErrorHBST Sub (506)1

23

Section A Error

HIV

Bad barcode

Empty

Bad barcode

EmptyEmpty

123456

OK

• Enter code of the correspondingline (code on MLE card).

• Go backautomatic printing of MLE

card.

Master Lot

clr6 / 16

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z +

Prev.

Select the number of the position with error.

1

ClrA1 BC

S T U V W X Y Z

A B C D E F G H I

- . / # ! + : < >

J K L M N O P Q R

ClrA1 BC

S T U V W X Y Z

A B C D E F G H I

- . / # ! + : < >

J K L M N O P Q R


Calibration error


Technical Support.

Troubleshooting 2/2

Section A Error123

4

56

HCG No Master Lot

Empty

HCGHCGHCG

HCG

No Master LotNo Master LotNo Master Lot

No Master Lot

Section A ErrorHCGHCG

EmptyEmpty

HCGHCG

Old standardOld standardOld standardOld standard

123456

Section A ErrorHCGHCG

EmptyEmpty

HCGHCG

No StandardNo StandardNo StandardNo Standard

123456

No existing calibration,

or

No identified position for standard in the status Screen

Expired standard

No Master Lot Data for the assay

Read the MLE card : See p 6

Perform a new calibration

Perform a calibration

Check and identify position for standard See p 7

Issues Solutions Press to stop an alarm and to access the Solutions’ menu.

?

5

Kit expired use a new lot

Lot error 4Section A Error

HBST Lot expired)123

Instrument use

Instrument use


Questions? The answer is in the package insert !

Page 1

• How to reconstitute and store Standards and Controls ? • How many Standards and Controls to run? • Which volume to pipette?

Page 3

• S1 X 2 or 3 ?• C1 or C1 + C2 +C3

• What is this test used for? • Which sample type is used ?Page 1

Page 3

Intended use

ProcedureKit description

Instrument use

Instrument use

Sample collection


1

Screwdriver Dacron swab(Part no. 30 531)

bleach solution(0.5-0.6% active

chlorine)

Small sponge cubes& curved forceps

Freshdistilled water

WEEKLY:Cleaning of the SPR blocks.

Fullu openthe section door.

Dacron swab + detergent solution

Clean the interior of each SPR sleeve.

Dacron swab + distilled water

Rinse each SPR sleeve.

curved forceps + sponge + detergent

Swab the rear of the SPR block pushing each SPR sleeve.

mini VIDAS « Grey » mini VIDAS « blue »

Remove the 2 screws

Open the strip’s preparation

tray by tilting it forward.

sponge + detergent solution

clean the 6 channels.

Repeat with a new sponge + bleach solution.

Sponge + distilled water.

Rinse each tray.

Raise the strip preparation tray and screw the 2 screws back into place.

MONTHLY:Cleaning of the reagent strip trays(similar procedure for underneath plastic tray).

Required material to do the maintenance.

H2OBleach

Solution

Powderless gloves


Technical Support.

10

10

2 3

1 2 3

Detergentsolution

Detergent solution

Instrument use

Instrument use

How to perform maintenance 1/3

Leave for

Leave for

• Instrument must be turned off.

Refer to user’s manual for detailed data.


MONTHLY:Cleaning the 2optical lenses.


How to perform maintenance 2/3Instrum

ent use Instrum

ent use


Technical Support.

VIDAS Lens cleanerreference 93567

With the pump, blow air on the 2 optical lenses.

optical lens

• Instrument must be turned off.


3

1MONTHLY:Performing VIDAS QCV test.


2

Instrument use

Instrument use


Technical Support.

VIDAS QCVreference 30706

QCV test must be run in EVERY position

How to interpret the QCV test :

Acceptable range for R3 :Each position must be

≥ 4100 RFU

check the R3 value

Acceptable range for TV1 : Each position must be ≥ TV1 valuewritten on the VIDAS® QCV kit label.

check the TV1 value

Code QCV

Run duration

20Start

Section A12

3

4

5

6

HCGHCG

HCG

HCG

HCG

S1S1

C1

100

951201001 GP

951201043 MD

100

No position identification required.

In case of out of range results :For TV1 :VIDAS® QCV strips must be re tested twice successively in each position.

If 2 out of 3 TV1 values for the same position are out of range, the position is defective.

PUT THE SECTION OFFLINE and Call bioMérieux Technical Support

For R3 : An system anomaly is suspected if at least one position produces a value for R3 < 4100 RFU.

PUT THE SECTION OFFLINE and Call bioMérieux Technical Support

TV1 xxxx

How to perform maintenance 3/3


Use a fixed volume pipette or set the correct volume (following manufacturer’s instructions.)

Put the tip inplace.

Note : Change the tip with each

new sample.

1 - Preparation:

Depress to the1st stop position.

2 - Aspiration

Dip the tip into the sample. Allow the plunger to smoothly return to the restposition.

4 - Home

A- Return to therest position.

B- Dispose of the tip.

A B

3 - Dispense

- Pipette sample into the sample well (1st

well) by smoothly depressing to the 2nd

stop.

How to use a pipette: patient sample

A - Prepare B - Aspirate C- Dispense

Position:• Rest• 1st stop• 2nd stop

1st well

Instrument use

Instrument use


2 – AspirationDip the tip into thediluent or water. Allow the plunger tosmoothly return tothe rest position.

B - Aspirate1- PreparationDepress to the1st stop position.

4- HomeA- Return to the

rest position.B- Dispose of the tip.

A B

C- Dispense3- DispensePipette diluent/water into the vial by smoothly depressing to the 2nd

stop.

How to use a pipette: Standard & Control reconstitutionInstrum

ent use Instrum

ent use

Note : Dependant on the assay,distilled water may be replaced by a specific diluent. REFER to the package insert.

Position:• Rest• 1st stop• 2nd stop

Note : Use the same procedure for control(s).

S1

Use a fixed volume pipette or set the correct volume (following manufacturer’s instructions.)

Put the Tip inplace.

Note : Change the tip with each

new sample.

A - Prepare


How to calculate centrifugation speed

The size of the rotor and operational speed (RPM)

determines the RCF (x g).

Use the Nomograph to calculate the speed in rpm or g.

How to calculate the centrifugation speed in rpm or in g

More information on : www.djblabcare.co.uk

Instrument use

Instrument use


PSA (Prostate Specific Antigen) is a protein produced by the cells of the prostate and secreted in the seminal fluid. PSA liquefies seminal fluid thereby increasing sperm mobility.

PSA is present in blood with 3 main forms:

PSAACT

MG

WHAT IS TPSA ?

Free PSAPSA-ACT

PSA-α2MG(not detectable)

Total PSA (TPSA)

WHY IS TPSA TESTED ?Healthy men have low levels of TPSA. However, TPSA levels rise in prostatic pathologies such as Benign prostatichyperplasia (BPH) or prostate cancer.

The VIDAS® TPSA test measures the level of Total PSA in blood.

Determination of TPSA levels is an AID in:

the detection of prostate cancer in conjunction with digital rectal examination (DRE) in men ≥ 50 years old. Prostate biopsy is required for diagnosis of prostate cancer.

the management of prostate cancer patientsto help determine effectiveness of prostate cancer treatment and to detect disease recurrence.

PSAPSA

Tumor M

arkers : VIDA

S TPSATum

or Markers : VID

AS TPSA

TPSA


Mix

Preparation Before use Storage

VIDAS TPSA: Reagent & Sample preparation

1500 g

Serum

Sample Type

Reagent handling

-25 ± 6°C

+2–8°C

• Only remove the required strips and SPRs.• Tightly close the SPR Bag immediately after use.• Return the kit to the refrigerator ASAP.

+2–8°C

Reagentreconstitution

S1

C1

Standard

Control

Freshdistilled water

H2O

S1

C1

30-25 ± 6°C

if > 24h

24 h

Preparation Storage

2 ml(2000 µl)

2 ml(2000 µl)

Let stand atRoom temperature.

Serum only Tumor M

arkers : VIDA

S TPSATum

or Markers : VID

AS TPSA

18°C

25°C


MixPrepare Status Screen (See page )

+2–8°C

VIDAS TPSA : Work Sheet

• Close SPR bag.

• Put the kit in the fridge ASAP.

• One Strip/SPR per sample, standard, control.

Load reagents and samples, following Status Screen (see page )

Remove reagents from the fridge

C1S1 +

-25 ± 6°C

30C1

S1

1 - Load SPR 1st2 - Load Strips

9

Pipette into the strips then start the analysis

Start

Section A12

3

4

5

6

HCGHCG

HCG

HCG

HCG

S1S1

C1

100

951201001 GP

951201043 MD

100

Code TPSA

Run duration

60

9

S1

C1

200 µl

X2

If Calibration is required :

Protocol compatibility TPSA, CEAS, 19-9, 125, FPSA

Let standRoom temperature.

Tumor M

arkers : VIDA

S TPSATum

or Markers : VID

AS TPSA

18°C

25°C1

2

3

4

• Frozen samples must be mixed after thawing.


Master Lot Data Entry

Lot Number _______________

Data Entry Date _______________

Calibration : S1 & C1

Date of 1st calibration _________________

Recalibration date _________________




A new calibration must be done:1. When a NEW lot is used.2. Every 14 days.

C1

S1

54321Only 5 Freeze/Thaw cycles are possible:

C1S1 and

-25 ± 6°C

2009

Freeze Thaw

Calibration frequency

A calibration must be done:1.When a NEW lot is used.2.Every 14 days*.

Maximum 5 times

Freeze and thaw

VIDAS TPSA: Calibration guidance VIDAS TPSA: Log sheetTum

or Markers : VID

AS TPSA

Tumor M

arkers : VIDA

S TPSA

Room temperature

18°C

25°C


bioMérieux, the blue logo and mini VIDAS are used, pending and/or registered trademarks belonging to bioMérieux S.A. or one of itssubsidiaries.

Disclaimer :This Easy Starter is a support containing short information of mini VIDAS system and reagent use.Please refer to the instrument’s instruction manual and to the specific reagent’s package insert for more details.

minividas immunoassay system manual 2

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