Unit: 1 Box (25 Tests)
Regulatory Status: CLIA Waived / Professional Use Only
Contents: (25) Test Cassette, (25) Extraction Solution, (25) Sterile Throat Swab, (1) Positive Control Swab, (1) Negative Control Swab, (1) Package Insert, (1) Procedure Card, (1) Extraction Kit containing 5 tubes and 5 disposable droppers for use with proficiency testing samples only
Determinations: Qualitative Group A Streptococcal (Strep A)
Storage Requirements: 59° – 86° F
Processing Time: 5 Minutes
The QuickVue In-Line Strep A Test is an accurate, two-step, on-site assay that offers a qualitative detection of Group A Streptococcus infection in 5 minutes or less. Group A Streptococcus is a bacterium responsible for a multitude of invasive and non-invasive infections ranging in severity from very mild to life-threatening. One of the most common non-invasive infections caused by Group A Streptococcus is known as strep pharyngitis, also known as strep throat. Strep throat is a bacterial infection of the throat and tonsils, which causes fever, pharyngitis (sore throat), anterior cervical adenitis, and malaise. Strep throat infections most frequently occur among school-aged children and teens, accounting for approximately 15-40% of cases of pharyngitis in this age group. Adults may also develop strep throat infections, but they are less common, making up only 5-10% of cases. Many other causes of pharyngitis have similar symptoms, so a visit to your health care provider is recommended for conclusive testing. Rapid strep testing can be a valuable diagnostic tool, allowing doctors to begin antibacterial treatment without delay, lessening the severity of the illness and the potential for life-threatening complications.
QuickVue In-Line Strep A Test Includes:
25 Individually packaged Test Cassettes
25 Bottle Extraction solution
25 Sterile Throat Swabs
1 Positive Control Swab
1 Negative Control Swab
1 Procedure Card
1 Package Insert
1 Proficiency Testing Extraction Kit containing: 5 Tubes & 5 Disposable Droppers
- Fast & Convenient – Two-step process yields results in 5 minutes
- Accurate – 92% Sensitivity, 99% Specificity, and 96% Accuracy Overall
- Easy-to-Read – Two-color endpoint qualitative results
- Dependable Performance – Includes both Internal & External Controls to insure compliance and confidence in results
- Long Shelf Life – 24 months from date of manufacture
- No special storage or shipping required – Stable at Room Temperature (59-86 degrees F)
- CLIA Waived
About Group A Streptococcus
Group A Streptococcus pyogenes is a Gram-positive, beta-hemolytic bacterium and is one of the most commonly known human pathogens. Group A streptococci can be found in the pharynx or on the skin of an estimated 5-15% of the population. Many of these carriers of have no symptoms of illness. The bacterium is responsible for a multitude of invasive and non-invasive infections ranging in severity from very mild to life-threatening. Some non-invasive infections include impetigo, cellulitis, erysipelas, strep pharyngitis (strep throat), and scarlet fever. These are termed non-invasive because the infection occurs in an area that Group A Streptococcus can normally be found. Invasive group A streptococcal infections take place when the bacteria gains access and colonizes in areas bacteria is usually not found, such as blood, muscle, bones, and organs. These infections are less common but much more serious and life-threatening. Examples of non-invasive Group A Streptococcal infections include septic arthritis, osteomyelitis, necrotizing fasciitis, and streptococcal toxic shock syndrome. There are numerous other types of Streptococcus, such as Streptococcus pneumoniae and Group B Streptococcus, which should not be confused with Group A Streptococcus.
About Strep Throat
Acute pharyngitis, also known as a sore throat, is a common ailment among all ages, leading to over 15 million visits to the doctor’s office each year. Most cases of acute pharyngitis are viral. However, Group A Streptococcus pyogenes is the leading cause of bacterial pharyngitis (strep throat), affecting up to 10% of adults and 25-40% of children and teens. Group A strep is spread through contact with infected nasal and pharyngeal fluids most often through direct person-to-person contact, coughing, sneezing, or the sharing of eating utensils or drinking cups. Individuals with weakened immune systems are the most susceptible to infection.
Strep throat symptoms usually occur 2 to 5 days after exposure and may range from mild to severe. The infection is characterized by a sudden onset of sore throat, sometimes with white patches; swollen tonsils; fever (over 101 degrees F); headache; fatigue; enlarged lymph nodes in the neck; loss of appetite; nausea; and on occasion, a sandpaper-like rash which initially appears on the neck and chest area and then spreads over the body. If left untreated, strep throat can lead to serious complications that could lead to permanent systemic damage including scarlet fever, rheumatic fever, tonsillitis, peritonsillar abscess, glomerulonephritis, mastoiditis, and guttate psoriasis. Fortunately, these complications are easily preventable with proper medical treatment. Rapid strep tests, such as the QuickVue In-Line Strep A, can determine the etiology of the illness and enable doctors to begin an antibiotic regimen and advise of additional supportive care techniques in a single office visit to facilitate a swift and complete recovery for their patients.