Malaria pan-R Malaria cassette. Agenda Disease overview Infectious agents Diagnosis pan-R Malaria...

Malariapan-R Malaria cassette

Agenda• Disease overview

• Infectious agents

• Diagnosis

• pan-R Malaria cassette: specifications

• Conclusion

Malaria Overview• One of the most common & serious tropical diseases

– 300-500 million clinical cases worldwide– 1-2 million deaths– 41% of the world's population live in areas where

malaria is transmitted – rising each year as drug resistance increases and

health systems deteriorate

• Transmitted via the female Anopheles mosquito

• No vaccine

Global distribution

Infectious agents• Caused by 4 species of protozoal parasites from the

Plasmodium genus

– Plasmodium falciparum– Plasmodium vivax– Plasmodium ovale– Plasmodium malariae

• P. falciparum causes the most severe form of the disease

• If P. falciparum infection is not treated or the parasites are resistant to the drug-therapy, the disease can become life-threatening

Infectious agents• P.falciparum infection is most prevalent throughout Africa

• Increasing P.falciparum infections throughout Latin America, the Western Pacific and the Asia-Pacific regions

• Rapidly developing resistance to many of the drugs commonly used to treat malarial infections

• Expensive drug combination therapies now needed

• Accurate and rapid diagnosis of infection is more crucial than ever

Diagnosis• Accurate, Rapid & Confident diagnosis of infection is

crucial to providing effective treatment to manage the disease

• Misdiagnosis improper & unnecessary treatment

– Increased therapy costs

– Increased risk of drug resistance

Diagnosis• Accurate, Rapid & Confident diagnosis:

– Appropriate & effective drug treatment– Greater control over spread of infection

• Great advantage for health workers to be able to differentiate a P. falciparum malarial infection

• Increasing importance on the accurate diagnosis of parasitaemia prior to treatment

• P. falciparum drug resistance– expensive multi-drug regimes

Diagnosis• The pan-R Malaria Cassette can:

– Detect all pathogenic malaria antigens, in whole blood – Differentiate a P.falciparum infection

• Provides qualitative detection of:

– Plasmodium falciparum– Plasmodium vivax– Plasmodium ovale– Plasmodium malariae

Diagnosis• Provides patients and health-workers with a useful

diagnosis

– Rapid implementation of therapy

– Correct therapy

– Prioritise precious (& expensive) resources

– Save lives

SpecificationsName: pan-R Malaria CassetteCat. No. R-MAL01DExpiry: 18 monthsStorage: 4 – 28°C (room temperature, below 30°C)Antigen: HRP2, P. aldolaseSample: Whole bloodTest time: 15 minutesKit size: 25 tests & Collection devices, 1 bottle of

bufferProcedure: 2 well cassette, 5uL serum, 5 drops of

buffer

Procedure

Interpretation

Performance CharacteristicsTable 1: Sensitivity and Specificity of the Panbio pan-R Malaria Cassette P. falciparum versus non-P. falciparum Characterised Specimens

Specimen characterisation (Microscopy & PCR)

Panbio pan-R Malaria Cassette

Positive Negative Total

P.falciparum 262 11 273

Non P.falciparum 32 3 35

Negative 1 316 317

Total 295 330 625

Performance Characteristics95% CI*

Serological Sensitivity(P. falciparum)

= 262/273 96.0% 92.9 - 98.0%

Serological Sensitivity(non-P. falciparum)

= 32/35 91.4% 76.9 - 98.2%

Serological Specificity (Negative)

= 316/317 99.7% 98.3 - 100.0%

Relative Serological Agreement

= 610/625 97.6% 96.1 - 98.7%

*Confidence Interval

pan-R Malaria Cassette

Product brochure

Summary Card

Competitors• DiaMed OptiMAL

• Binax NOW

• Standard Diagnostics

• Core Diagnostics

Binax NOW OptiMAL

Panbio

Conclusion

www.panbio.com