NNew ew SSnapnapTMTM BBeta-eta-LLactamactam

Areas neat, clean, orderly, well ventilated, and temperature controlled (4 – 300C or 39.2 – 860F)

Adequate lighting – 50 foot-candles at working surface (preferable 100)

Incubator/Heater Block with Snap™ inset 45±50C Thermometer, for each incubator Level

WWork ork AArearea

PPipettor ipettor CCalibrationalibration Fixed volume pipettors for certified labs –

450ul. Range = 427.5 to 472.5

Calibrated with 10 consecutive weighings once every 6 months.

Weighing must be + 5% of the specified volume.

Records maintained.

PPipettor ipettor CCalibrationalibration

Serial number etched or use manufacturers ID number.

Tag pipettor with average weight, date, location, and analyst’s initials.

Only the screening labs may use the disposable bulbs supplied by Idexx.

TThermometerhermometer CCalibrationsalibrations The NIST traceable thermometer calibrated at ice

point annually.

The “in use” thermometer calibrated against a NIST traceable at each temperature of use upon receipt and annually.

All thermometers must be checked at each temperature of use.

Tag includes temperature checked at, date of check, analysts initials and correction factor.

Records maintained.

8/25/2005 LTSnap Block # 4P

45.1 - 0.1C

RRefrigerator efrigerator TTemperaturesemperatures

Thermometers placed – top / bottom shelves. Check daily for Screening / twice a day for Certified Labs.

Record adjusted values only. Adjust temperature of the refrigerator if necessary to maintain temperature (0-4.40C). Document.

Records maintained.

RRefrigeration efrigeration RRequirementsequirements

Remove only enough Snap tests for each use period (i.e., to test one or a small group of incoming loads).

Do not store Snap tests at room temperature. Store at 0 to 70C.

Do not store food for consumption in the refrigerator.

Record date received/analyst and the date opened/analyst on the box of Snap tests.

FFresh resh PPositive ositive CControlsontrols Record the following information from the positive control

in the QA/QC record.

Idexx Positive Controls must be stored at 0 - 300C.

1. Manufacture.

2. Lot #.

3. Expiration Date.

4. Date & Time made.

Re-hydrate with inhibitor free raw milk and let sit for 10 minutes. Good for 24 hrs at room or fridge temps.

NNegative egative CControlsontrols Obtain a raw milk sample from a silo/tanker/holding

tank that has been pre-tested and found (NF) with the Snap Beta-Lactam Test and use it as a Negative Control.

Identify the negative control sample and include the date, the silo it was taken from, the time and the analyst.

Records maintained.

Fresh negative control is good for 72h when maintained at 0-4.40C.

NNew ew LLot ot NNumbersumbers

Test each new lot with a positive & negative control to make sure they are working properly. Record on separate form.

The lot number on the silver package is the 3 digit number followed by two alpha characters. LOT

#

WWork ork AArearea Wash hands prior to testing samples.

Clean counter area and wipe dry.

Keep the incubator clean. Wipe off splashed milk.

Run Performance Checks each day of testing.

Run negative and positive controls for each day of testing.

All controls must give appropriate reactions.

If out of range, manufacturer should be contacted for corrective action.

Records maintained

HHeater eater BBlocklock Snap incubator temperature must be checked and results

recorded each day of use. 45 + 50C.

The block temperature is checked by placing a standardized thermometer in a tube containing liquid or the bulb submersed in the heating unit.

Record time, date, and temperature of the samples as received and tested.

Determine sample temperature by inserting a pre-cooled thermometer into the temperature control (TC).

Digital thermometers do not need pre-cooling.

Do not accept samples that are more than 3/4 full.

NNew ew SSnap nap TTestest Label each Snap device and each sample tube.

Identify the sample being tested (tanker, positive control, negative control).

Place the Snap devices on the heater block.

Place the test tubes in a rack. (Not in the heater block.)

Look for the blue reagent pellet in the bottom of the tube, if not there, tap gently to bring the pellet down.

Remove and discard the sample tube cap (s).

Leave the pellet in the tube, do not remove the pellet.

NNew ew SSnap nap TTestest Mix all of the samples and controls by shaking 25 times

in 7 seconds through a 1 foot arc. Use within three minutes.

All shaking must done vigorously.

All Certified Analysts must use a fixed volume pipettor.

Use a separate tip for each sample and control.

Hold sample at an angle to avoid the foam.

The pipettor tip may go into the sample no more than 1 cm.

TTest est PPortionortion

•Tilt sample container at a 45 degree angle

•Pipet up to 1 inch into milk

•Avoid foam

TTest est PPortionortion

Draw up the sample/control into the pipettor tip and expel to pre-wet the tip.

Remove the test portion. Touch off the pipettor tip on a clean dry area inside the sample container.

SScreening creening OOnlynly

Only screening facilities may use the disposable pipettors provided by IDEXX.

Hold the sample at an angle, to avoid foam.

With the pipettor provided, place the tip of the pipettor in the sample (no more than 1 cm), draw the test portion up past the indicator line.

Remove the pipet from the milk and then touch the pipettor tip to a dry area inside the sample container.

Adjust the sample down to the line.

NNew ew SSnap nap TTestest

Carefully add all of the sample to the correctly identified and labeled tube(s).

Use a clean pipettor tip/disposable pipettor for each sample and control.

The used pipet tips are placed in disinfectant before they are thrown away.

NNew ew SSnap nap TTestest Agitate all sample/control tube(s) to completely

dissolve the blue reagent tablet. Do this by rocking the tubes in a back and forth motion.

Incubate the sample/control tube (s) next to the snap device with the corresponding ID.

Incubate the tube (s) at 45 + 50C for 5 minutes.

A timer must be used.

NOTE: a watch, clock… are unacceptable.

NNew ew SSnap nap TTestest

After 5 mins are up, immediately pour the contents of the tube(s) into the proper sample well(s) of the device(s).

Make sure the last drop is delivered into the sample well.

Once all devices have been snapped, set the timer for 4 minutes.

Read immediately.

WWhen hen TTo o SSnapnap Snap the device just as the blue activation circle begins

to disappear.

Be sure to snap the device down firmly so the top is completely flush with the base.

Too early to snap.

Snap.

Too late to snap. (Washed out)

NNew ew SSnap nap TTestest

The control spot is on the top and the test spot is on the bottom when the activator button is to the right of the sample well.

Not Found (NF) - The test spot is darker or equal to the control spot.

Positive - The test spot is lighter than the control spot.

Interpretation with SnapShot ONLY.

NF

POS

IIdexx dexx SSnapshot napshot RReadereader Only use the stylus or your fingers when

entering information on the Snapshot reader.

Make sure the date and time information is correct.

Select the test kit type (beta-lactam…).

Enter the kit lot number.

IIdexx dexx SSnapshot napshot RReadereader

Enter the sample/control identification number.

Enter operator ID.

Insert the snap device.

Push read

The daily printout is attached to the daily worksheet.

Negative reading = Not Found. Record NF.

Positive reading on initial – run new controls and same sample in duplicate by the same analyst.

Both duplicates NF with proper control reactions – can receive the load.

If one or both of the duplicate tests give a positive result – the load is Presumptive Positive (PP). Fill out positive load form and call the state.

SScreening creening TTestest