McKesson's Consult Strep A tests are designed to assist healthcare professionals in the early detection of group A streptococcal antigen, commonly known as strep throat. The external positive and negative controls included in the kit help ensure accurate results. These rapid tests are used to identify the presence of the streptococcus organism, allowing for timely and accurate patient diagnosis.

Features:

• Long Shelf Life: 24-month shelf life from the date of manufacture.
• Individual Packaging: Each test is individually packaged for single-patient use.
• Quick Results: Read test results in just 5 minutes, enabling rapid patient diagnosis.
• Single Use Reagent Capsules: Ensures ease of use and contamination prevention.
• Cassette Format: Uses a cassette for the test media, which simplifies the procedure.
• Quality Controls: Includes external positive and negative quality controls for accuracy.
• High Sensitivity and Specificity: Sensitivity of 96.2% and specificity of 98.7% provide reliable test results.
• CLIA Waived: Meets Clinical Laboratory Improvement Amendments (CLIA) standards for simplicity and safety.

Intended Use:

The McKesson Consult Strep A Test Cassette is a rapid immunochromatographic assay intended for the qualitative detection of group A streptococcal antigen directly from throat swab specimens. It is designed for use in physician's offices, hospitals, and clinical laboratories to aid in the clinical diagnosis of group A streptococcal infection.

Contents:

• (25) Test Cassettes
• (25) Sterile Swabs
• (25) Extraction Reagent Capsules
• Positive Control
• Negative Control
• Instructions for Use
• Procedure Card

Precautions:

• For in vitro diagnostic use only.
• Do not interchange materials from different product lots.
• Do not use after the expiration date indicated.
• The test kit should be used only with the swabs supplied with the kit.
• Reagents A and B are slightly caustic. Avoid contact with eyes, sensitive mucous membranes, cuts, abrasions, etc. If these reagents come in contact with the skin or eyes, flush with a large volume of water.
• Do not smoke, eat or drink in areas where the specimens or kit reagents are handled.
• Wear disposable gloves while handling the kit reagents or specimens and wash hands thoroughly afterwards.
• All patient samples should be handled as if capable of transmitting disease.
• Observe established precautions against microbiological hazards throughout all procedures and follow standard procedures for the proper disposal of specimens.
• The McKesson Consult Strep A Test Cassette should remain in its original sealed pouch until ready for use. Do not use if the pouch is damaged or the seal is broken.
• The control solution contains sodium azide, which, on contact with lead or copper plumbing, may react to form explosive metal azides. Use a large volume of water to flush reagents on disposal.

Storage:

• Do not freeze.
• Kit contents are stable until the expiration date is printed on the outer box.
• The McKesson Consult Strep A Test Cassette may be stored at 35-86°F (2-30C) in the original sealed pouch, out of direct sunlight.

Test Procedure:

1. Twist the tab off of the Extraction Reagent Capsule.
2. Squeeze the Extraction Reagent Capsule to dispense all the contents into the Extraction Well.
3. Place the specimen swab in the Swab Stand in the Extraction Well. Hold the device with one hand and hold the swab with the other hand. While pressing down on the swab, spin the swab in one direction approximately 5 times to mix the specimen.
4. Incubate 1-2 minutes with swab in well.
5. Hold the device with one hand and hold the swab with the other hand. While pressing down on the swab, spin the swab again 5 times in one direction. Remove and discard the swab.
6. Raise device until upright.
7. Let stand 1-2 seconds. Tap device on flat surface to ensure liquid flows into hole.
8. Immediately after tapping, slowly lay the device back down onto the flat surface.
9. Read test results after 5 minutes but not after 10 minutes

• The product warranty is applicable as per the terms and conditions provided by the product manufacturer.

Please call us for specific details.

• No returns will be accepted after 30 days from the date of shipment.
• All returns are subject to a restocking fee as per manufacturers terms and conditions.
• All returns must have an RGA number (Returned Goods Authorization), unauthorized returns will not be accepted.
• We do not guarantee fulfillment of any desired purpose or product suitability to the user and this will not be considered as a valid reason for return.
• The products must be new, unused condition, not tampered with, in original packaging and returned at the customers expense in the original packaging.
• If your return is not due to any manufacturing defect then the original shipping cost will be deducted from the total refund.
• Hygiene, bath and toilet items cannot be returned once opened or used.
• Standard manufacturer terms and conditions apply for return policy of this product.

Please call us for specific details.