McKesson Consult Strep A Rapid Test Kit 25 Tests – CLIA Waived is a rapid chromatographic immunoassay designed for the qualitative detection of Group A Streptococcal antigen from throat swab specimens. The visual-read dipstick format provides results in approximately 5 minutes and requires no dedicated analyzer, making it suitable for professional point-of-care testing environments.
Each 25-test kit includes individually pouched dipsticks, disposable extraction tubes, sterile specimen swabs, extraction reagents, external positive and negative controls, workstations, and instructions for use. The test is CLIA Waived and intended for professional in vitro diagnostic use.
Key Features
| 5-Minute Results | CLIA Waived | Visual Dipstick Format |
| Provides rapid results during the patient visit | Suitable for testing under applicable CLIA-waived requirements | Requires no dedicated instrument or analyzer |
| Group A Strep Detection | Complete 25-Test Kit | External Controls Included |
| Qualitatively detects Strep A antigen from throat swabs | Includes core collection, extraction, and testing components | Positive and negative controls support quality-control procedures |
| Professional Point-of-Care Use | Individually Pouched Tests | Latex Consideration |
| Designed for professional clinical testing environments | Helps protect unused dipsticks until testing | Not made with natural rubber latex |
Specifications
| Attribute | Details | Attribute | Details |
| Brand | McKesson Consult | Manufacturer | McKesson |
| MPN | 5003 | Product Type | Rapid Diagnostic Test Kit |
| Test Name | Strep A Test | Test Type | Infectious Disease Immunoassay |
| Target | Group A Streptococcal Antigen | Test Format | Dipstick |
| Sample Type | Throat Swab | Reading Type | Visual |
| Time to Results | Approximately 5 Minutes | CLIA Classification | CLIA Waived |
| Number of Tests | 25 | Intended Use | Professional In Vitro Diagnostic Use |
| Sensitivity | 97% | Specificity | 95% |
| Analyzer Required | No | External Controls | Positive and Negative Controls Included |
| Latex Indicator | Not Made with Natural Rubber Latex | Shelf Life | 24 Months |
| Product Packaging | KT/25EA | Minimum Selling Unit | KT |
| BAA Compliant | Yes | TAA Compliant | Yes |
| UNSPSC | 41116129 | Test Category | Point-of-Care / Respiratory Testing |
Kit Contents
| Component | Quantity / Description |
| Test Dipsticks | 25, individually sealed |
| Extraction Test Tubes | Disposable |
| Specimen Swabs | Sterile |
| Reagent 1 | 10 mL |
| Reagent 2 | 10 mL |
| Positive Control | 1 mL |
| Negative Control | 1 mL |
| Workstations | Included |
| Instructions for Use | Included |
Warnings
| Professional IVD Use Only | Negative Results | Follow Instructions for Use |
| Intended for professional in vitro diagnostic testing | Negative results should be confirmed by culture according to the test instructions | Follow the complete procedure, timing, and interpretation requirements supplied with the kit |
| Specimen Collection | Quality Control | Biological Safety |
| Use appropriate throat-swab collection technique and avoid contamination | Perform control testing according to facility procedures and the instructions for use | Treat patient specimens and used test materials as potentially infectious |
| Expiration Dating | Single-Use Components | Result Interpretation |
| Do not use components beyond their labeled expiration dates | Do not reuse disposable swabs, dipsticks, or extraction tubes | Interpret results together with the patient's clinical presentation and other available information |