Warnings and Precautions for In Vitro Diagnostic Kits

WARNINGS AND PRECAUTIONS ◼ For in vitro diagnostic use ◼ Do not use beyond the expiration date printed on the outside of the box. ◼ The Dipstick must remain sealed in the protective foil pouch until just prior to use. ◼ Reagent B contains an acidic solution. If the solution contacts the skin or eye, flush with large volumes ofwater. ◼ Use of nitrile or latex gloves is recommended when handling the Extraction Reagents within this kit.3,4 ◼ Do not interchange reagent bottle caps. ◼ If Reagent B is green prior to mixing with Reagent A in the Tube, do not use and contact Technical Support. ◼ To obtain accurate results, you must follow the Package Insert instructions. ◼ Testing should be performed in an area with adequate ventilation. ◼ Dispose of containers and unused contents in accordance with Federal, State and Local regulatoryrequirements. ◼ Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this kit. ◼ Wash hands thoroughly after handling. ◼ For additional information on hazard symbols, safety, handling and disposal of the components within thiskit, please refer to the Safety Data Sheet (SDS) located at quidel.com. KIT STORAGE AND STABILITY Store the kit at room temperature, 59°F to 86°F (15°C to 30°C), out of direct sunlight. Kit contents are stableuntil the expiration date printed on the outer box. Do not freeze. SPECIMEN COLLECTION AND STORAGE Collect throat swab specimens by standard clinical methods. Consult standard reference procedures such as the collection method described by Miller and Holmes.5 Depress the tongue with a tongue blade or spoon. When swabbing the throat, be careful not to touch the tongue, sides or top of the mouth with the Swab. Rubthe Swab on the back of the throat, on the tonsils and in any other area where there is redness, inflammationor pus. Use rayon tipped swabs to collect throat specimens. Do not use calcium alginate, cotton tipped or woodenshaft swabs. It is recommended that swab specimens be processed as soon as possible after collection. Swabs can be held in any clean, dry plastic tube or sleeve up to 72 hours at room temperature (15°C to 30°C), or refrigerated (2°Cto 8°C) before processing. The use of charcoal or agar medium is not recommended. If a culture is desired, lightly streak the swab on a 5% sheep blood agar plate before using the Swab in the QuickVue Dipstick Strep A Test. Do not perform the QuickVue Dipstick Strep A Test before streaking the Swab,as the Extraction Solution will destroy the bacteria on the swab, thereby rendering the organism incapable of successful culturing. Alternatively, throat swab specimens can be obtained by dual Swabs or by two sequentialSwabs for the culture procedure. CULTURE CONFIRMATION The QuickVue test can be used to confirm the identification of Group A Streptococcus on blood agar plates.Lightly touch a colony using a sterile Swab. Do not sweep the plate. Follow the instructions in the TEST PROCEDURE section to test the Swabs. QUALITY CONTROL Built-in Control Features The QuickVue Dipstick Strep A Test provides three levels of internal procedural controls with each test run. Fordaily quality control, Quidel recommends documenting that these internal controls were checked for the first sample tested each day. ◼ The color of the Extraction Reagent changes from clear to green as the reagents are mixed together. The color change is an internal extraction reagent control and is an indication that the reagents are mixed andfunctioning properly. ◼ The appearance of a blue Control Line is an internal control. The Dipstick must absorb the proper amountof sample and the Dipstick must be working properly for the blue Control Line to appear. Additionally, theappearance of the Control Line indicates that capillary flow occurred. ◼ A clear background is an internal background negative control. If no interfering substances are in the sample and the Dipstick is working properly, the background in the Result area should be white to lightpink within 5 minutes and not interfere with the reading of the test result. External Quality Control Testing External controls may also be used to demonstrate that the reagents and assay procedure perform properly. Quidel recommends that Positive and Negative Controls be run once for each untrained operator, once for each new shipment of kits - provided that each different lot received in the shipment is tested - and as deemedadditionally necessary by your internal quality control procedures, and in accordance with Local, State, and Federal regulations or accreditation requirements. If the controls do not perform as expected, repeat the test or contact Quidel Technical Support before testingpatient specimens. Normal Values: Negative ASSAY PROCEDURE ◼ Do not remove Dipsticks from the foil pouch until ready to perform the assay. ◼ To avoid cross contamination, do not allow the tip of the reagent bottles to come in contact with sampleSwabs. TEST PROCEDURE Important: ◼ Gloves should be worn when handling samples. ◼ Do not use Reagent B if the solution is green prior to mixing with Reagent A in the Tube. If this occurs,contact Technical Support. 1. Just before testing, add 3 DROPS of Reagent A and 3 DROPS of Reagent B into aclean Tube. This solution should turn green. When adding drops, hold bottle vertically so that a complete drop forms. 2. Immediately add the patient Swab sample to the Tube. Squeeze the bottom of theTube so the Swab head is compressed. Rotate the Swab a minimum of 5 times. Keep swab in Tube for 1 minute. 3. Express all liquid from the Swab against the inside of the tube. Squeeze the Swabfirmly as it is removed from the Tube. Discard the Swab. 4. Remove the Dipstick from the foil pouch. Place the Dipstick into the Tube with the arrows of the Dipstick pointing down. Do not handle or move the Dipstick until the testis complete and ready for reading. 5. Read result at 5 minutes. Some positive results may appear sooner.