Description
Manufacturer: Abbott
Brand: BinaxNOW™
Product Type: Rapid Immunoassay / Pneumococcal Antigen Test
Target Organism: Streptococcus pneumoniae
Specimen Types: Urine and cerebrospinal fluid (CSF), as applicable under manufacturer instructions
Result Time: Approximately 15 minutes
Test Format: Qualitative antigen detection
Primary Item #: ALR710000
Test Quantity: 22 tests per box
Accessory Item #: ALR710010 – Swab Pack, 10/Pack
Product Description
The Abbott BinaxNOW™ Streptococcus pneumoniae Test is a rapid immunoassay designed for the qualitative detection of Streptococcus pneumoniae antigen in appropriate clinical specimens.
The assay is intended to aid healthcare professionals, together with culture and other diagnostic methods, in evaluating suspected pneumococcal pneumonia and pneumococcal meningitis. Results are available in approximately 15 minutes, supporting timely clinical decision-making in hospitals, laboratories, emergency departments, and other professional diagnostic environments.
According to the Medline product information shown for this assay, the test provides approximately 85% sensitivity and 94% specificity.
Key Features & Benefits
- Rapid Results: Produces qualitative results in approximately 15 minutes.
- Detects S. pneumoniae Antigen: Designed specifically for pneumococcal antigen detection.
- Urine Testing Application: Supports evaluation of patients suspected of pneumococcal pneumonia.
- CSF Testing Application: May be used with cerebrospinal fluid in patients being evaluated for pneumococcal meningitis, according to manufacturer instructions.
- Simple Rapid-Test Format: Designed to facilitate point-of-care or near-patient diagnostic workflows where permitted.
- Supports Clinical Diagnosis: Intended for use alongside culture and other diagnostic information.
- Professional Diagnostic Use: Suitable for appropriately equipped healthcare and laboratory environments.
- Compact Test Format: Helps simplify storage, distribution, and rapid diagnostic testing workflows.
Performance Characteristics
Approximate sensitivity: 85%
Approximate specificity: 94%
Time to result: Approximately 15 minutes
Performance must be interpreted in accordance with the manufacturer's current instructions for use, specimen requirements, patient population, and testing conditions.
Available Purchasing Options
ALR710000 – BinaxNOW S. pneumoniae Test Kit
Manufacturer Item #: ALR710000
Description: BinaxNOW S. pneumoniae Test
Quantity: 22 Tests / Box
Unit of Measure: 22/BX
This is the primary diagnostic test configuration.
ALR710010 – BinaxNOW Swab Pack
Manufacturer Item #: ALR710010
Description: BinaxNOW Swab Pack, Strep / Pneumonia
Quantity: 10 / Pack
Unit of Measure: 10/PK
Important: ALR710010 is an accessory/swab pack and should not be represented as a complete diagnostic test kit.
Clinical Applications
Potential professional-use settings include:
- Hospital laboratories
- Emergency departments
- Acute-care facilities
- Clinical laboratories
- Infectious disease services
- Pulmonary / respiratory evaluation
- Neurology and meningitis diagnostic workflows
- Urgent-care environments
- Physician-office laboratories where permitted
- Point-of-care diagnostic programs where applicable
Intended Diagnostic Role
The BinaxNOW S. pneumoniae assay is intended to serve as an aid in diagnosis and should not be used as the sole basis for determining whether a patient has pneumococcal disease.
Test results should be interpreted alongside:
- Clinical signs and symptoms
- Patient history
- Culture
- Additional microbiological testing
- Imaging where applicable
- Other laboratory findings
Product Specifications
| Specification | Details |
|---|---|
| Manufacturer | Abbott |
| Brand | BinaxNOW™ |
| Analyte | Streptococcus pneumoniae antigen |
| Test Type | Qualitative rapid immunoassay |
| Result Time | Approximately 15 minutes |
| Specimen | Urine / CSF as specified by manufacturer |
| Sensitivity | Approx. 85% |
| Specificity | Approx. 94% |
| Primary Item # | ALR710000 |
| Primary Package | 22 Tests / Box |
| Accessory Item # | ALR710010 |
| Accessory Package | 10 Swabs / Pack |
| Professional Use | Yes |
Important Ordering Information
ALR710000 is the complete BinaxNOW S. pneumoniae test configuration shown in the catalog.
ALR710010 is a separate swab/accessory pack and should be ordered only when appropriate for the intended workflow and compatible Abbott BinaxNOW procedures.
Always confirm the current Abbott package insert, storage requirements, expiration dating, specimen requirements, quality-control requirements, and regulatory status before use.
Storage & Handling
Store the product according to the temperature range and conditions specified on the Abbott labeling and current instructions for use.
Do not use:
- Expired tests
- Damaged test devices
- Compromised packaging
- Improperly stored materials
- Reagents or accessories outside their labeled conditions
Important Diagnostic Notice
This is an in vitro diagnostic product intended for professional use according to the manufacturer's labeling and applicable regulatory requirements.
A negative result does not necessarily exclude pneumococcal infection, and a positive antigen result should be interpreted in the context of the patient's clinical presentation and other diagnostic findings.
Healthcare professionals should consult the current Abbott instructions for use before testing.
