Text X316.2IE v1802
XEMAtest Pork Fat/Blood
Rapid test strip method for on-site determination of contamination of pork fat or pork blood in raw, cooked 
or processed meat.
Version of the test 1 (1109)

A pig (Sus scrofa domesticus) belongs to the genus Sus, within Suidae family. The wild ancestor of domestic pig is wild boar (Sus scrofa), other related species from the same family are peccary and warthog.
Consumption and handling of the materials of porcine origin is strictly prohibited by some religious confessions. Porcine components may be also used for adulteration of foods and cosmetic products. XEMAtest Pork Fat/Blood detects species specific antigen – porcine serum albumin. This protein is a major constituent of animal serum and is widely present in all body tissues, including subcutaneous fat (lard). 

XEMAtest Pork Fat/Blood is based on immunochromatographic principle (lateral flow). The target antigen is bound by specific antibodies attached to colored microparticles. Then this complex migrates to the test line where binds to another specific antibody to form a colored line indicating positive result.

The test is applicable for qualitative detection or semiquantitative measurement of target antigens in the samples of complex foods and surface swabs. The qualitative detection is usually done for screening and the semiquantitative measurement is applied for monitoring or comparative studies.

TEST SENSITIVITY AND SPECIFICITY
XEMAtest Pork Fat/Blood utilizes a combination of monoclonal antibodies against porcine serum albumin.
The test detects the antigens of all swine varieties, including wild swine (boar). 
The test is non-reactive to all other species tested by now: cow, sheep, horse, goat, moose, reindeer and other deers, chicken, turkey, goose, duck, rabbit, kangaroo. The test is also negative with human blood.

A sensitivity of XEMAtest Pork Fat/Blood (LOD, limit of detection) is 1 ppm for the mixture of blood samples; the range of detection is 1-10000 ppm. In solid materials (eg the mixture of liver homogenates) the sensitivity is 4 ppm with the range of detection (ROD) 4-20000 ppm. 
In dry spots or other types of the material collected by wet swabs according to present instruction, the LOD is approximately 0,5 ug/ 100 square centimeters for fat extract

The test is NOT CAPABLE TO DETECT porcine blood and fat components in the material which was processed by profound heating (higher than 130 degrees Celsius for longer than 15 minutes), for example after frying or long microwave cooking. The test also does not detect porcine collagen (gelatin).

PLEASE NOTE: the sensitivity is calculated for the target antigenic material content in solid material extracted by the method described below, (solid/liquid ratio 1:10 wt/vol). The sensitivity of the test may be upgraded by lowering of the solid/liquid ratio, however this may result in thick liquid which will not penetrate into the test strip. The LOD data for liquid samples are 5x lower with standard procedure, ie with regular liquid specimens the test reaches higher sensitivity.

More details of test performance (sensitivity, specificity, variability, influence of matrix and processing) are available on request or online at www.xematest.com

If the visual test gives unclear results, we recommend to recheck the sample by the quantitative laboratory methods, e.g. ELISA (Xema, Cat# K316) or PCR.

CONTENTS
-	2 test strips individually packaged into sealed pouches;
-	2 specimen collection tubes;
-	Instruction for use.
SPECIMEN HANDLING 
The specimens should be brought to temperature range +18...+35 °C before use; testing of colder specimens diminishes the sensitivity of the assay; testing of hot specimens is NOT possible!
The test is designed to detect the target antigen in different types of the material, please select the relevant section of the text below.
TEST PROCEDURE FOR SOLIDS
1.	Allow the test strips to reach room temperature for 5-10 minutes before opening the pouches. 
2.	Put a small piece of tested material (0,1-0,5 g) into a Specimen collection tube. If the balances are available, record the actual weight in grams. 
3.	If the accurate volume measurement tool (pipette) is available, calculate required tap water volume as 10x actual weight (for example, if the weight is 0,23 g, add 2,3 ml of water). Otherwise, add not more than half of tube volume of tap water. Adjust the sensitivity of the assay if the weight/volume ratio is different from 1:10.
4.	Screw the cap securely onto the tube and shake vigorously for 15 – 30 seconds or use the vortex mixer. Allow to settle for 2 minutes. 
5.	If the liquid is thick and cloudy, it may not penetrate into the test strip, and testing fails. To avoid it, allow to settle for longer period (up to 6 hours). The extract may be also filtered by textile material or centrifuged.
6.	Open the pouch, taking care not to damage the test strip. Dip the test strip into the liquid layer, do not touch the solid settled down on the bottom.
7.	Allow the strip to remain in the solution for 5 – 10 seconds. Remove the test strip and place onto a clean horizontal surface; do not touch or move the test strip for 10 minutes. Read the test result. 

CAUTION: ENSURE THE TEST STRIP IS DIPPED AS SHOWN IN A FIGURE. THE DIRECTION AND THE DEPTH OF IMMERSION MUST BE AS SHOWN FOR CORRECT OPERATION. 

TEST PROCEDURE FOR LIQUIDS
The limitation for liquid specimens is their viscosity and turbidity (presence of particulate matter). If the specimen is viscous and cannot reach the test zone of the test strip, it should be diluted by tap water right in the Specimen collection tube or separately. In this case, the sensitivity of the test should be adjusted by dilution factor. Cloudy specimens should be allowed to settle, filtered through textile material, or centrifuged.
1.	Allow test strips to reach room temperature for 5-10 minutes before opening the pouches. 
2.	Collect 1 ml of liquid specimen into a Specimen collection tube (by first marker on the tube wall or using a pipette).
3.	Add an equal volume of tap water, screw the cap securely onto the tube and mix by shaking or use the vortex mixer.  If the liquid is cloudy, allow to settle, then follow the instructions from point 5 of test procedure for solid materials outlined above
TEST PROCEDURE FOR SURFACE SWABS 
1.	Allow test strips to reach room temperature for 5-10 minutes before opening the pouches.
2.	Add 1 ml of tap water to the tube into a Specimen collection tube (by first marker on the tube wall or using a pipette)
3.	Place the swabbing tool (for example, cotton tip) into the tube, rinse the swabbing tool in water
4.	Squeeze off any excessive liquid off the swabbing tool against the tube wall
5.	Swab the tested surface with special attention to suspected spots. 
6.	Put the swab back into the tube containing the rest of water and shake vigorously for 15 – 30 seconds or use the vortex mixer.
7.	Remove the swab from the tube and follow the instructions from point 5 of test procedure for solid materials outlined above.
INTERPRETATION OF THE RESULTS
Test is considered POSITIVE if TWO colored lines appear in the test zone.

Test is considered NEGATIVE if only ONE colored line is clearly visible.
 
If NO colored line is formed, the test is INVALID. 

Try to repeat it with another test strip, check the correct specimen handling and test procedure, expiry date and storage conditions.

PRECAUTIONS
*The test strips should be stored at +10...+30  °C
*Use the test within 10 minutes after opening the pouch because the test strips are very sensitive to moisture
*Do not touch the reaction membrane
*Do not use the test strip if its pouch is torn, or test strip is broken or damaged
*The test strips are disposable; do not use them repeatedly
*Do not use the test strips beyond the expiration date

MANUFACTURER: 
Xema group of companies
www.xematest.com