Microsoft word - aaf-11141_user_guide_20130901.doc
AccuDipTM Salbutamol Rapid Test Strip
General Description Salbutamol (albuterol) is a β2-adrenergic receptor agonist, and has been marketed to treat bronchospasm caused by asthma or exercise, and chronic obstructive pulmonary disease. When added to animal feed, it can increase body muscle percentage, slow down fat deposition and promote animal growth. However, when residual salbutamol in food enters human body, it can pose immediate health risks, leading to dizziness, palpitation, anxiety, tremor, headache, vomiting, and muscle cramps. Therefore, it has been strictly prohibited to be used on farmed animals. The AccuDipTM salbutamol rapid test strip provides a rapid and convenient test for salbutamol with a colloidal gold immunochromatographic design. It can detect salbutamol in urine, blood serum, and animal feed of livestock and poultry either on site or in the lab, providing a fast (results shown in 10 minutes), simple, sensitive and reliable detection approach for the presence of salbutamol. The lower limit of detection (LOD) of salbutamol in the sample is 3 ng/ml (3 ppb). Intended Use
The AccuDipTM salbutamol test strip is a lateral flow strip test for rapid on-site or in-lab detection of residual salbutamol in urine, blood serum, and animal feed of livestock and poultry. Assay sensitivity: 3 ng/ml (3 ppb) Safety Instructions
To receive complete safety information on this product, contact AccuAffinity, Inc. and request Material Safety Data Sheet. Assay Principles
AccuDipTM salbutamol test strip is based on the principle of colloidal gold immunochromatography. An anti-salbutamol antibody is conjugated to colloidal gold and placed on conjugate pad. Colloidal gold provides red color to visualize antibody-antigen binding. Salbutamol antigen is immobilized on nitrocellulose membrane. After test sample is loaded onto sample pad, it mixes with gold-antibody conjugate and migrates along the membrane. If the sample contains no salbutamol or amount of salbutamol lower than detection limit, antibody conjugated to colloidal gold will bind the antigen immobilized on membrane, leading to clear red color presented on membrane detection line where the test antigen is immobilized (as negative result). If salbutamol concentration is higher than detection limit in the test sample, it will bind gold-antibody conjugate and prevent its binding onto the antigen line on membrane. As a result, no color will be visible on detection line on membrane (indicating positive result). Reagents and Materials in each pack a) 1 salbutamol test strip b) 1 disposable dropper c) 1 pack of desiccant Sample Collection and Test Procedure
Equilibrate test strip to room temperature (20-25oC)
Equilibrate test sample to room temperature (20-25oC)
Collect approx. 20 ml of urine sample using a clean centrifuge tube or other suitable container. Sample needs to be frozen if immediate testing is not possible. Refrigeration is recommended for short-term storage, and care must be taken to avoid microbial growth or contamination. Centrifuge sample when precipitation or turbidity is visible, and supernatant is used as test solution.
Draw blood from animal to be tested, and centrifuge or keep still to collect transparent upper layer (blood serum) as test solution. If excessive hemolysis is observed, dilute serum 2-fold with distilled water before testing.
Pulverize animal feed sample, and pass through a sieve with mesh size 20. Place 2 grams of this pulverized sample in a 50 ml centrifuge tube, and add 10 ml distilled
water and mix well, followed by ultrasound treatment in 37oC ultrasonic water bath for 30 minutes (with mixing every 10 minutes). Equilibrate contents of the tube to room temperature, centrifuge at 4000 rpm for 5 minutes and collect supernatant as test solution. Add 2 drops of test solution from a), b) or c) described above into sample loading well with a disposable dropper, and observe result in 8 to 15 minutes.
Result Interpretation Test result is interpreted by observing test line and control line shown in result window. Negative (-): both test and control lines are present, and test line is equal to or darker than control line. This indicates salbutamol concentration in sample is lower than 3 ng/ml; Positive (+): control line is present, and test line is either absent or lighter than control line. This result indicates salbutamol concentration is higher than 3 ng/ml in sample; Invalid test: no control line is present. Please repeat the test using a new test strip following instructions on this user guide.
1. Test strip is for one-time use only. Please use the test strip on the same day the package is opened. 2. Do not use tap water, purified water, or distilled water as negative control. 3. Test should be performed at room temperature, and test strip and sample both need to be equilibrated to room temperature before the test. 4. If no liquid movement is observed in the test window 30 seconds after test solution is added to sample loading well, add one more drop of test solution. 5. Positive samples identified by test strip are recommended to be verified with other approaches (such as HPLC or GC-MS).
Storage and Expiration Date
Storage: Room Temperature Expiration Date: 12 months after manufacturing date. Technical Assistance For ordering or technical assistance regarding this product, or for additional information about AccuAffinity products, please email firstname.lastname@example.org or call (408) 368- 1364. General Limited Warranty AccuAffinity, Inc. warrants its manufactured products against defects in materials and workmanship when used in accordance with the applicable instructions for a period not to extend beyond a product’s printed expiration date. AccuAffinity makes no other warranty, expressed or implied. There is no warranty of merchantability or fitness for a particular purpose. The warranty provided herein and the data, specifications and descriptions of AccuAffinity products appearing in published catalog and product literature may not be altered except by express written agreement signed by an officer of AccuAffinity. Representations, oral or written, which are inconsistent with this warranty or such publications are not authorized and, if given, should not be relied upon. In the event of a breach of the foregoing warranty, AccuAffinity Inc.’s sole obligation shall be to repair or replace, at its option, any product or part thereof that proves defective in materials or workmanship within the warranty period, provided the customer notifies AccuAffinity promptly of any such defect. The exclusive remedy provided herein shall not be deemed to have failed of its essential purpose so long as AccuAffinity is willing and able to repair or replace any nonconforming AccuAffinity product or part. AccuAffinity shall not be liable for consequential, incidental, special or any other indirect damages resulting from economic loss or property damage sustained by a customer from the use of its products. However, in some states the purchaser may have rights under state law in addition to those provided by this warranty.
CHECKLIST FOR PRESCRIBERS – COMBINED HORMONAL CONTRACEPTIVES Please use this checklist in conjunction with the Summary of Product Characteristics during combined hormonal contraceptive (CHC) consultations. Thromboembolism (e.g. deep vein thrombosis, pulmonary embolism, heart attack and stroke) is a rare but important risk with use of a CHC. A woman’s risk will also depe
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of FCC Rules. These limits are designed to provide reasonable User’s Manual protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the ins