Salbutamol Residue Rapid Test Card

1. INTENDED USE

The Salbutamol Residue Rapid Test Card is a rapid, one step test for the qualitative detection of Salbutamol in meat samples. The whole time of assay is only approx. 15~25min.

2. SUMMARY

Salbutamol belongs to the group of ¥Â-agonists. It can promote animalÿ®s fat metabollism, and accelerate the growth of animal. However, this is prohibitted. Except for its lipolytic and anabolic effect, Salbutamol is used as antiasthmatic and tocolytic agent which has a slacken effect on non-striated musculature. It can remain in animalÿ®s body and may lead to strong effect to human. If for worse, it may threaten peopleÿ®s life. Salbutamol is prohibitted for using in most countries.
The Salbutamol Residue Rapid Test Card is a rapid test to qualitatively detect the presence of Salbutamol in specimen at the sensitivity of 5¥Ìg/kg. The major advantage of the one step test device is that the result can be observed easily .
3. PRINCIPLE

The principle is the antigen-antibody reaction. The one step test device is a competitive immunoassay of which the detector reagent consists colloidal gold particles that is coated with affinity purified anti-Salbutamol antibodies. The capture reagent in the assay is Salbutamol-protein conjugate, which is immobilised on the membrane of the test device. The specimen migrates over the membrane. The more analyte in the sample, the more effectively it will compete with the Salbutamol immobilised on the membrane for binding to the limited amount of antibodies of the detector reagent.. If Salbutamol in the specimen is above 5¥Ìg/kg, it will prevent the binding of the detector reagent with the Salbutamol immobilised on the membrane, resulting in positive.
4. PRECAUTIONS

¡¬Do not use after the expiration date.
¡¬The test device should remain in the sealed pouch until use.
¡¬Use device as soon as possible but within 1 hour after removal from the pouch specially if the room temperature is more than 30oC and in high humidity environment.
¡¬Do not touch the white membrane in the mid of the test device.
¡¬Do not use the ethyl acetate in the unventilated room.

5. STORAGE AND STABILITY
Store at room temperature (4ÿ?30ÿ?. DO NOT FREEZE or use beyond the expiration date .The shelf life is 12 months.
6. MATERIALS PROVIDED

¡¬ Salbutamol Residue Rapid Test Card (50 devices)
¡¬Desiccant¡§one piece per sealed pouch¡¨
¡¬PBST buffer only for SAL, pH 7.4 (one vial per kit)
¡¬Throw away plastic dropper (50 pieces per kit)
¡¬Package Insert

7. SPECIMEN TREATMENT

Extraction Method for meat
The samples should be stored in a cool place, protected against light.

¡¬Weigh 4g of homogenized sample into a 15 mL centrifugal vial, and heat in the 90ÿ?water bath for 10min.
¡¬Suck three drops of the cool up liquor into 1.5mL centrifuge tube, and then add three drops of PBST buffer only for SAL.

8. TEST PROCEDURE
Read the entire procedure carefully before performing any test.
Keep the reagent at room temperature before testing.

1. Prepare samples according to chapter 7 (Specimen treatment).
2. Remove the Salbutamol Residue Rapid Test Cards from sealed pouch.
3. Hold the dropper vertically and transfer 3 full drops of solution obtained from specimen treatment to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration above.
4. Wait for red bands to appear. The result should be read in approximately 3-5 minutes. It is significant that the background is clear before reading the test. Do not interpret results after 5 minutes.

9. INTERPRETATION OF RESULTS
NEGATIVE:
Two lines are visible and the Test Line (T) is the same as or darker than the Control Line (C), which also is the Reference Line (R). This indicates that the Salbutamol concentration in sample is below 5¥Ìg/kg.

POSITIVE:
Two lines are visible, but the Test Line (T) is lighter than the Control Line (C), or there is no Test Line. This indicates that the Salbutamol concentration in sample is above 5¥Ìg/kg.

INVALID:
Reference Line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for an invalid result. Review the procedure and repeat the test with a new test device. Stop using the test kit immediately if the problem is not solved and contact your local distributor.

10.QUALITY CONTROL
Procedural control is implemented. A red band appears in the control region (C), which is also the reference region (R)that is for internal procedure control. It ensures efficientness and correct procedure technique.Control standard is not supplied in this device. Proper laboratory practice is the confirmation of the test procedure and test performance.
11.LIMITATION OF THE PROCEDURE
(1). The Salbutamol Residue Rapid Test Card is only a preliminary analytical result. A secondary analytical method must be taken for confirmation. Gas chromatography and mass spectrometry method (GC/MS) is preferred .
(2). The Salbutamol Residue Rapid Test Card is a qualitative screening assay and cannot test the Clenbuterol concentration in the specimen.
(3). It is possible that technical or procedural errors, as well as other interfering substance in the specimen may cause falseness.

12.PERFORMANCE CHARACTERISTICS

Sensitivity

The sensitivity of 5¥Ìg/kg is acquired through reduplicating experiment on the sample containing 5¥Ìg/kg Clenbuterol.

Specificity

Negative result can be seen if mix the Salbutamol Residue Rapid Test Card with standard Ractopamine(1000¥Ìg/kg).

No cross-reaction with Chloramphenicol, Streptomycin, Tetracyclines, or Sulfamethazine.

Precision

A multi-center test evaluation is conducted between tthe Salbutamol Residue Rapid Test Card and other products. 286 specimen are tested, including 146 negative and 140 positive. 96.7% of the Salbutamol Residue Rapid Test Card is effective when comparing to other ELISA Salbutamol reagents