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CTK Biotech OnSite® Malaria Pf/Pan Ag Rapid Test CE
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Specimen: Whole blood
Specifications:
| Application | Diagnostic Testing |
| Storage Temperature | Room Temperature |
| Product Type | Test Kit |
| Product Brand | CTK Biotech |
| Product Grade | Medical grade |
The OnSite Malaria Pf/Pan Ag Rapid Test CE is a lateral flow chromatographic immunoassay designed for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) and non-falciparum species—P. vivax (Pv), P. ovale (Po), and P. malariae (Pm)—in human whole blood specimens. The test is CE marked and meets WHO acceptance criteria, offering a rapid and reliable tool for early diagnosis and treatment decision-making, especially in resource-limited settings.
This test is ideal for point-of-care use in both clinical and remote environments where microscopy or molecular methods are not available, enabling rapid and accurate diagnosis of malaria infections within 15–20 minutes.
Key Features and Benefits
- Dual Detection Capability: Differentiates P. falciparum from non-falciparum Plasmodium species (Pv, Po, Pm)
- CE Certified: Meets World Health Organization (WHO) performance standards
- User-Friendly Format: Requires minimal training for personnel
- Minimal Equipment Needed: No microscopes or instrumentation required
- Quick Turnaround: Results available in approximately 15–20 minutes
- Ideal for Field Use: Compact, portable design for remote or mobile clinics
- Cost-Effective: Economical alternative to lab-based testing with high diagnostic value
- Supports External Quality Assurance: Compatible with Positivia external controls
Kit Contents (30-Test Kit)
- 30 test cassettes (individually sealed with desiccant)
- 30 blood transfer devices (sample loops, capillary tubes, or mini droppers)
- 1 × 10 mL Blood Lysis Buffer (REF SB-R0113)
- 1 Package insert (Instructions for Use)
Product Specifications
| Attribute | Details |
|---|---|
| Detection Target | Pf HRP-II antigen and pan-Plasmodium aldolase antigen |
| Species Detected | P. falciparum, P. vivax, P. ovale, P. malariae |
| Sample Type | Whole Blood (fingerstick or venous) |
| Sample Volume | 5 µL |
| Time to Results | 15–20 minutes |
| Certification | CE Marked |
| Format | Lateral Flow Cassette |
| Kit Size | 30 tests per kit |
| Storage Conditions | As per manufacturer instructions |
| External Control Compatible | Yes – with Positivia controls |
| Intended Use | For professional in vitro diagnostic use |
Applications
- Rapid diagnosis of malaria in clinical settings
- Point-of-care malaria screening in endemic regions
- Malaria testing in remote, rural, or mobile clinics
- Travel medicine and border health surveillance
- Emergency room and outpatient malaria triage
The Malaria Pf/Pan Ag Rapid Test CE provides a fast, reliable, and easy-to-use diagnostic solution for malaria detection and species differentiation. CE certified and WHO-compliant, it enables early and appropriate malaria management, particularly in low-resource settings where laboratory services are limited or unavailable. Its portability, simplicity, and accuracy make it an essential tool for global malaria control programs and field-based diagnostics.