In Vitro Diagnostic Use
CADY® Malaria
Pf/Pv Ag Rapid Test
Simultaneous detection and differentiation of P. falciparum and P. vivax antigens from whole blood in 20–25 minutes — no laboratory equipment required.
Five Simple Steps
Performing the Test, Start to Finish
Follow each step in order. Read your result only within the 20–25 minute window.
Prepare
Bring the kit and specimen to room temperature (15–30°C). Place the cassette on a flat, clean surface.
Collect Sample
Collect 5µL of whole blood using the supplied lancet and capillary tube (inverted cup).
Apply Blood
Dispense the entire 5µL specimen into the sample well, then add 3 drops of assay buffer.
Wait 20–25 Min
Let the test run undisturbed. Do not move the cassette or read results before 20 minutes.
Read & Interpret
Identify the C, Pf and Pan lines. Dispose of the cassette per local biohazard regulations.
Video Guide
See the Test In Action
A two-minute walkthrough of the full procedure, from sample to result.
Result Guide
How to Interpret Your Result
The cassette has three lines: C (Control), Pan (pan-Plasmodium species), and Pf (P. falciparum-specific). The C line must always appear for a valid result.
Negative / Non-Reactive
No Plasmodium antigen detected in the specimen.
P. falciparum Positive
Presence of pHRP2 antigen indicates P. falciparum infection.
P. vivax Positive
Presence of pLDH antigen. Pf negative — reactive for P. vivax.
Mixed Infection
All three lines visible — both pHRP2 and pLDH detected. Confirm species by additional testing.
Invalid Result
No C line appeared regardless of other lines. Test is invalid — repeat with a new device.
A faint line, however light, is still considered positive. If both Pf and Pan lines are faint, it is recommended to interpret the result as P. falciparum positive in conjunction with clinical findings.
Why CADY
Built for Accuracy, Designed for the Field
Results in 20–25 Minutes
Rapid lateral-flow technology delivers actionable results in under 30 minutes — no waiting, no delays in treatment decisions.
Dual Antigen Detection
Simultaneously detects pHRP2 (P. falciparum) and pLDH (Pan) antigens, differentiating Pf from Pv in a single test run.
~99% Sensitivity & Specificity
Validated on 952 clinical specimens (380 Pf, 572 Pan). Relative sensitivity 99.65%, specificity 100% vs. blood smear reference.
No Laboratory Equipment
Designed for field clinics, mobile health units, remote dispensaries and point-of-care settings with no electricity or equipment required.
50 Parasites/µL Detection Limit
Minimum detection limit of 50 parasites/µL, calibrated against the WHO malaria reference standard for early-stage sensitivity.
No Cross-Reactivity
Tested against Typhoid, Dengue, HIV, Hepatitis B, RNA and rheumatoid factor panels — zero cross-reactivity across all tested specimens.
Technical Data
Specifications & Resources
Product Specifications
| Test Name | CADY Malaria Pf/Pv Ag Rapid Test |
|---|---|
| Catalog Ref. | RHEL/PRD/MAL01 |
| IFU No. | IFU/LRH/MAT/060, 01/12/2023 |
| Format | Lateral flow immunoassay (cassette) |
| Sample Type | Whole blood (fingertip or venipuncture) |
| Sample Volume | 5 µL |
| Buffer | 3 drops Blood Lysis Buffer (100–120 µL) |
| Read Time | 20–25 minutes (invalid after 30 min) |
| Detection Limit | 50 parasites/µL |
| Sensitivity (Pf) | 99.65% (n=380 specimens) |
| Sensitivity (Pv) | 99.65% (n=572 specimens) |
| Specificity | 100% (both Pf & Pv) |
| Storage Temp. | 1–30°C (do not freeze) |
| Shelf Life | 18–24 months |
| Unit Size | 25 tests / box (1 test per sealed pouch) |
| Field Use | 25 tests / box (1 test per sealed pouch) |
| Accessories | Cassette, buffer, lancet — all supplied |
| Storage Required | Safely sealed, clock/timer (not supplied) |
| Regulatory | CE Marked · ISO 13485 · WHO PQ submitted |
| Manufacturer | Revital Healthcare (EPZ) Ltd., Mombasa, Kenya |
Documents & Resources
Official documents for healthcare professionals and procurement teams.
- Instructions for Use (IFU)
- ISO 13485 Certificate
- Biohazard Disposal Guide
- National Regulatory Authorities (NRAs)
Care Guide
Storage & Handling
Proper storage ensures full performance and accuracy through the test's shelf life.
Store at 1–30°C
Room Temperature
Keep in original packaging until use. Avoid direct sunlight and damp storage areas.
Keep Away From Sunlight
Light Protection
Direct sunlight and UV exposure can degrade reagent performance over time.
Single Use Only
One Pouch, One Test
Do not reuse cassettes. Each sealed pouch contains exactly one complete test.
Biohazard Disposal
Used Test Disposal
Treat used cassettes and lancets as biohazardous waste per local safety regulations.
FAQs
Frequently Asked Questions
Common questions about the CADY Malaria Pf/Pv test, answered clearly.
Yes. Any visible line in the Pf or Pan window, however faint, should be read as a positive result. Line intensity does not correlate reliably with parasite density.
Yes, the test can be performed regardless of fever state. However, recent antimalarial treatment may lower antigen levels and increase the chance of a false negative.
The test specifically identifies P. falciparum (Pf line) and gives a pan-specific signal (Pan line) shared by P. vivax, P. malariae and P. ovale. It does not differentiate between the three non-falciparum species individually.
Results read after 30 minutes are considered invalid due to potential evaporation artifacts and non-specific binding. Repeat the test with a new cassette.
Use the cassette immediately after opening the pouch, ideally within 1 hour, in a dry environment away from humidity.
Hemolyzed or clotted specimens are not recommended, as they may interfere with sample flow and produce unreliable results. Use fresh capillary or venous whole blood.
An invalid result (no control line) usually indicates insufficient sample volume, expired buffer, or procedural error. Discard and repeat with a new cassette and fresh sample.
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