Healgen® Rapid Strep A Antigen Test CLIA Waived

Diagnose Strep A in Just 5 Minutes with the Healgen Rapid Antigen Test

*For Prescription Use Only.

Streptococcus pyogenes is non-motile gram-positive coccus, which contains the Lancefield group A antigen that can cause serious infections such as pharyngitis, respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis. Left untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess.' Traditional identification procedures for Group A Streptococci infection involve the isolation and identification of viable organisms using techniques that require 24 to 48 hours or longer.

The Rapid Strep A Antigen Test is a rapid test to qualitatively detect the presence of Group A Streptococcal antigen in throat swab specimens, providing results within 5 minutes. The test utilizes specific and sensitive antibodies reactive to the Rapid Strep A Antigen and is specific to group A with no cross-reactivity from other groups of Streptococci.

When speed and accuracy matter most, the Healgen® Rapid Strep A Antigen Test delivers results you can trust—in just 5 minutes. Designed for frontline healthcare professionals, this CLIA-waived test provides a fast, reliable solution for detecting Group A Streptococcal infections using a simple throat swab. Each kit comes packaged with 25 complete test units, making it ideal for high-volume settings like hospitals, clinics, urgent care centers, and pharmacies. With no need for additional equipment, you can streamline your diagnostic process, improve patient satisfaction, and reduce unnecessary antibiotic use—all while saving time and resources.

Each Strep A Antigen Test Kit contains enough reagents and materials for 25 tests.

25 Test Strips 25 Disposables Specimen Extraction Tubes 25 Collection Sterile Swabs Extraction Reagent: Reagent A (10mL): 2.0 M Sodium Nitrite Solution. Reagent B (10mL): 0.2 M Acetic Acid Solution. Standard controls: Positive Control (1mL): Non-viable Strep A; 0.05% ProClin™ 300. Negative Control (1mL): Non-viable Strep C; 0.05% ProClin™ 300. Leaflet with instructions for use: 1 Instructions For Use 1 Quick Reference Instructions (QRI)

Benefits of a Rapid Strep A Antigen Test

When a Rapid strep throat test is performed it will determine whether a patient's sore throat is viral or bacterial. Every year 15 million Americans see the doctor for sore throat and 70 percent of them get antibiotics to treat it, according to the Infectious Diseases Society of America. When a Rapid Strep A Test shows a negative result for bacterial infection, it reduces "unnecessary" antibiotics prescriptions written by physicians. The infection may be caused by a viral infection and viruses do not respond to antibiotics. Researchers analyzed over 70,000 results from patients under 15 years old with sore throat that where performed rapid strep test and only 24% where positive for group A streptococcus pharyngitis. When a at home strep test is performed can potentially eliminate the need for doctor's visits.

• Fast Turnaround: Diagnose and treat patients during a single visit
• All-in-One Kit: Includes swabs, reagents, test device, and instructions
• CLIA-Waived: Suitable for use in non-laboratory settings
• Accurate & Reliable: High sensitivity and specificity
• Cost-Effective: Bulk box of 25—ideal for high-volume testing

Difference Between a Sore Throat and Strep Throat Infection

Understanding the distinction between a sore throat and a strep throat infection is crucial for appropriate treatment. A sore throat can often be caused by a viral illness, and it is essential to differentiate this from a bacterial infection like strep throat to avoid the unnecessary use of antibiotics. Several different viruses can lead to the common cold and upper respiratory infections, which may result in a sore throat. These viral sore throats typically resolve on their own with at-home care, such as rest, hydration, and over-the-counter pain relievers.

In contrast, strep throat is a less common but more serious type of sore throat caused by streptococcal bacteria. This bacterial infection requires treatment with antibiotics to prevent complications. A rapid strep test is important for accurately identifying strep throat. If left untreated, strep throat can lead to serious health issues such as kidney inflammation and rheumatic fever. Rheumatic fever is a condition that can cause painful, inflamed joints, a rash, and even damage to heart valves, leading to long-term health problems. Therefore, accurate diagnosis and prompt treatment of strep throat are essential to prevent these potential complications and ensure effective recovery.

One of the significant benefits of rapid strep testing at home is the convenience it offers. Home testing allows individuals to quickly determine whether they have a bacterial infection without the need to visit a doctor's office, which can be time-consuming and costly. Early detection and treatment are facilitated, reducing the risk of complications and preventing the spread of infection to others. Additionally, home testing can help alleviate anxiety by providing quick and reliable results, enabling prompt medical intervention if necessary. This accessibility to rapid testing empowers individuals to take control of their health and make informed decisions about their treatment and care.

Strep A testing often involves a throat culture, which helps identify the presence of group A streptococcus bacteria. During the test, a healthcare professional swabs the back of the throat and tonsils. This simple procedure is essential in diagnosing and treating strep throat accurately.

Group A streptococcus bacteria can spread through droplets from a cough or sneeze, making prompt testing crucial. Early diagnosis ensures that appropriate treatment can be started quickly, helping to alleviate symptoms and prevent complications. Always seek advice from a healthcare provider if you suspect a strep infection.

Principle

The Rapid Strep A Antigen Test is a qualitative, lateral flow immunoassay that uses antibodies to detect carbohydrate antigen from Strep A in throat swabs. During testing, a throat swab is collected and added to buffer. The sample is added to the test. If Strep A antigen is present in the sample, a colored line will form at the test line at "T", which means the test is positive. If Strep A antigen is not in the sample, a test line will not appear at "T", which means the test is negative. A colored line will always appear at the control line "C" indicate the test is working and proper test procedure has been followed.

Sample Collection

Only use the reagents and sterile swabs provided in the kit. For best results, throat swabs should be tested immediately after collection. If immediate testing is not possible, a direct throat swab may be stored in a clean, dry plastic tube for 2-4 hours at room temperature (15-30°C/59-86° F) or 24 hours at 2-8°C (36-46°F). If a culture is desired, lightly roll the swab tip onto a Group A selective (GAS) blood agar plate before using the swab in the Rapid Strep A Antigen Test.

Test Procedure

The test should be performed at room temperature (15-30°C/59-86°F). Allow the test materials to reach room temperature prior to use. Do not open the Test Strip until you are ready to use.

Place an empty extraction tube in the tube holder. Hold the Reagent A bottle vertically over the empty extraction tube and add 4 full drops of Reagent A. Reagent A is light red in color.

Hold the Reagent B bottle vertically over the same tube and add 4 full drops to the tube. Reagent B is colorless. Mix the solution by gently swirling the extraction tube.

Immediately place the throat swab into the extraction tube. Mix well by rolling the swab in a circular motion at least 10 times. Press the swab tip against the bottom and sides of the tube while rolling. Leave the swab in the tube for 1 minute.

Remove the swab while pressing the swab against the side of the tube and squeezing the bottom of the tube as the swab is withdrawn. Discard the swab.

Remove the test strip from the foil pouch. Do not touch the bottom of the strip. Place the test strip into the tube with the arrows of the strip pointing down. Start a timer for 5 minutes. Do not handle or move the strip until the test is complete and ready for reading.

After 5 minutes, read the tests results visually in the results window, labeled as "C" and "T" on the test strip. Do not read the results before 5 minutes or after 10 minutes.

Interpretation of Results

Positive Result

If the Control (C) line and the Test (T) line are visible, the test is positive. Any visible faint red or pink test (T) line with a visible control (C) line should be read as positive.

Negative Result

If the Control (C) line is visible, but the Test (T) line is not visible, the test is negative. A negative test result indicates that Strep A was not detected in the sample.

Invalid Result

If a control (C) line is not visible, the test is not valid. Invalid tests should be repeated with a new test.

Note:

Insufficient specimen volume, incorrect operation procedure, or the use of expired tests are the most likely reasons for control band failure.

Negative results are presumptive and should be confirmed by bacterial culture.

Important Notes.

A Certificate of Waiver is required to perform this test in a CLIA Waived environment. Laboratories with a Certificate of Waiver must follow the manufacturer's instructions for performing the test 42 CFR 493.1 S(e)(l) Failure to follow the instructions or modification to the test system instructions will result in the test no longer meeting the requirements for waived classification.

This product is intended only for the detection of Group A Streptococcal antigens from throat swab specimens and not for the detection of any other bacteria or pathogens.

The Healgen® Rapid Strep A Antigen Test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Reagent A and B are caustic. Avoid contact with eyes, sensitive mucous membranes, cuts, abrasions, etc. If these reagents contact the skin or eyes, flush with a large volume of water.