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
Microsoft word - aaf-11141_user_guide_20130901.docAccuDipTM 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).
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
Assay sensitivity: 3 ng/ml (3 ppb)
To receive complete safety information on this product, contact AccuAffinity, Inc. and
request Material Safety Data Sheet.
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.
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.
For ordering or technical assistance regarding this product, or for additional information
about AccuAffinity products, please email email@example.com or call (408) 368-
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.
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