Streptococcus Group A (Strep A)
PDB ID: 4OFQ. Source: RCSB Protein Data Bank. For illustration purposes only.
VeriGoldTM 化脓性链球菌
The VeriGoldTM Strep A Rapid Antigen Detection Test is a chromatographic immunoassay for the qualitative detection of Group A Streptococcus (Strep A) antigen in throat swab specimens. Group A Streptococcus is a common bacterial cause of pharyngitis and other upper respiratory tract infections, particularly in children and adolescents, but it can also affect adults. The assay provides rapid results at the point of care, supporting timely clinical evaluation of patients presenting with sore throat and related symptoms.
As a qualitative test, results are reported as positive or negative, assisting healthcare professionals in the assessment of suspected streptococcal infection. Rapid identification of Strep A may help guide appropriate patient management decisions in clinical, primary care, and urgent care settings. Negative results should be interpreted in conjunction with clinical findings and, where necessary, confirmed using culture methods.
| Ref. Code | 808087-1 |
| Analyte | Group A Streptococcus (Streptococcus pyogenes) antigen |
| Format | POCT rapid test (cassette / cartridge) |
| Quantitative / Qualitative | Qualitative |
| Reading Time | 10 minutes |
| Measuring Range | Not applicable |
| Cut-off Value | Not applicable |
| Sensitivity / Specificity | 88.42% / 100% |
| Storage Conditions | 2–25°C |
| Shelf Life | 18 months |
| Certificate | CE |
| Sample Types | Throat swab specimens |
| Sample Volume | 2 drops (approximately 100 µL) of extraction mixture from the extraction tube |
| Collection Method | Throat swab specimen collection |
| Sample Stability | Stable for testing within 1 hour at room temperature (as validated) |
| Acceptable Anticoagulants | Not applicable |
| Notes on Handling | Specimens should be collected and handled using standard laboratory procedures. Use fresh samples when possible and avoid hemolyzed, lipemic, or contaminated specimens. |
| Detection Method | Immunochromatography |
| Antibody Format | Monoclonal / sandwich |
| Signal Generation | Colloidal gold |
| Reading Method | Visual |
| Mechanism | The assay is based on a sandwich chromatographic immunoassay principle, where Group A Streptococcus (Strep A) antigen present in the throat swab extract binds to specific labeled antibodies as the sample migrates along the membrane by capillary action. The resulting antigen–antibody complexes are captured by immobilized antibodies at the test line, producing a visible signal indicating the presence of Strep A antigen in the specimen. |
| Tests per Kit | 20 Tests |
| Dimension of Kit Box | 16.5 × 13.5 × 8cm |
| Boxes per Carton | 55 Kits |
| Tests per Carton (Bulk) | 1100 Tests |
| G.W. per Carton (Boxed) | 20.5 kg |
| G.W. per Carton (Bulk) | 23.9 kg |
| Carton Dimension | 67 × 57.5 × 39 cm |
| Carton Volume | 0.15 CBM |
| Packaging Format | Individual sealed test kits / bulk configuration (as applicable) | Items Included | - 20 test cassettes- 20 extraction tubes with dropper caps- Reagent 1 (5 mL)- Reagent 2 (5 mL)- Instructions for Use |
| Storage & Shipping Conditions | Standard ambient transport; store according to product label requirements |
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深圳市康生保
生物技术有限公司
深圳市宝安区
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新和 社区 安达
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518103
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info@ksbbiotech.com