McKesson Consult Strep A Rapid Test Kits indicate whether cultures of Strep A are present in sizable quantities in a given sample. Since strep is an infection commonly found in young children, having a quick and accurate test is vital to any pediatric clinic.
These rapid strep throat test kits identify the presence of group A streptococcal antigen, include external positive and negative controls to deliver more accurate results and ultimately help healthcare professionals provide a more actionable patient diagnosis. Each rapid strep test kit offers 97% sensitivity and 95% specificity to avoid vague or inconsistent results.
That's why McKesson Consult Strep A Test Kits are easy-to-use and even CLIA waived. Plus, you'll have your results in just 5 minutes with a 97% accuracy and 95% specificity. Consult Strep A test kits come in packs of 25 (McKesson 5003) and 50-count (McKesson 4999) boxes provide healthcare facilities, clinics and caregivers with convenient and easy-to-use strep tests. Rather than draw out a diagnosis, each test provides results in about five minutes.
Consult Strep A test kits include dipsticks, test tubes, swabs, reagents and external positive and negative quality controls. These tests are for in vitro diagnostic use only.
Product Specifications
- Strep throat tests detect the Strep A antigen via a throat swab sample
- CLIA waived
- An economic and convenient solution to test patients for strep throat
- Individually packaged; designed for single-patient use
- Not made with natural rubber latex
- 24-month shelf life
- Item Number: 5003, 4999
- Manufacturer: Mckesson
- Shelf Life: 24 Months
- Tests per Kit: 25, 50
- Latex Indicator: Not Made With Natural Rubber Latex
- Type: Visual Read
- Test Name: Strep A Test
- Each 25-count set of kits includes: 50 dipsticks (2 vials of 25), disposable extraction test tubes, sterile swabs, reagent 1 (10 mL; 2M Sodium Nitrite), reagent 2 (10 mL; 0.2M Acetic Acid), positive control (1 mL; Non-viable Strep A; 0.09% NaN3), negative control (1 mL; Non-viable Strep C; 0.09% NaN3), an instructional insert and a workstation
Instructions for Use
- Allow dipstick, reagents and controls to reach room temperature prior to testing
- Wash hands and don a pair of exam gloves and eye protection prior to performing a test
- Collect throat swab
- Add four drops of Regent 1 (red) inside the test tube
- Add four drops of Reagent 2 (clear) inside same test tube
- Contents of the test tube should turn pale yellow
- Tap the bottom of the tube to gently mix the liquid
- Immediately add throat swab into the yellow solution
- Rotate the swab vigorously 10 times inside the liquid solution
- Leave the swab inside of the tube for one minute
- Press the swab tip against the side of the tube while removing, so most of the liquid remains in the tube
- Discard swab
- Remove the test dipstick and use it immediately
- Place dipstick inside the solution, arrows facing down
- Leave the dipstick inside the tube for five minutes
- Results of the test will be unreliable after 10 minutes of performing the test
Interpreting Results
A positive result is indicated by two distinct red lines appearing on the dipstick. One line should be in the control region, and the other in the test region. The red line in the test region may be lighter in hue compared to the control line; this line will vary in color based on the concentration of detected Strep A cultures. So, if the test region is lighter in color, the result is still positive. A positive result indicates the presence of Strep A in the sample.
A negative result is indicated by a single red line appearing in the control region but none in the test region. A single red line in the test region, but none in the control region represents an invalid result. This result means no strep was detected in the sample. If no lines appear, then the results are invalid. This means that the strip was unable to detect a result due to damage or the procedure was performed incorrectly.
External Quality Control Tests
It's recommended by the manufacturer that positive and negative controls be performed at least once per new kit. It's also recommended that you use the included external controls for this particular test. Below are the steps for doing so.
- Add four drops of Reagent 1 (red) and four drops of Reagent 2 (clear) into an extraction test tube
- Tap the test tube gently to mix the Reagents
- Add one drop of positive or negative control solution into the tube
- Place a clean swab into the tube
- Rotate the swab 10 times vigorously
- Allow clean swab to remain in the tube for one minute
- Press the swab against the tube while removing to ensure as much liquid as possible remains in the tube
- Discard the swab and insert the dipstick with arrows facing downwards into the tube
- Leave the dipstick inside the tube for five minutes before reading the results
Storage and Handling
It's recommended that the test kit be stored at room temperature or refrigerated. Dipsticks should remain in their canister until use. After removing a dipstick, it's recommended the user securely replace the cap as quickly as possible, because failure to do so can result in the remaining dipsticks to lose their effectiveness. Dipsticks expire after the date printed on the canister or 12 months after the bottle seal is first broken. It's recommended the user mark the date the dipstick bottle is opened on the bottle itself to keep track of when dipsticks expire.
Precautions
- This item is for professional use only
- It's preferable to refrain from eating, drinking or smoking in the vicinity where specimens are handled
- Please treat all samples as if they contain infectious agents
- It's recommended user wear proper protective equipment before performing a test
- Defective dipsticks should be discarded and not used
Warning Reagent 1 (red) Is Harmful if It Comes Into Contact With Skin or Is Swallowed
Caution Reagent 2 may Cause Eye and Respiratory Tract Irritation.
Included control solutions contain NaN3 as a preservative. NaN3 is acutely toxic
It's recommended to not switch reagents or control solution bottle caps
Reusing All or Part of The Test Kit After Use May Cause Inaccurate Results
NaN3 in control solutions may react with copper or lead plumbing forming harmful chemicals. always dispose of control solutions with copious amounts of water to prevent dangerous buildup.
Temperature and humidity can affect the results of the tests
Product Features and Benefits
- Rapid Tests with 97% Accuracy
- CLIA Waived and Easy-to-Use
- Results in 5 Minutes
- External Positive and Negative Controls
- Kit Options for 25 and 50 Tests
Manuals and Documents
Product Manual contains use and care instructions.
- Product Brochure contains product information.
- Safety Data Sheet contains important safety instructions.
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