Codix recently signed a sole agency agreement with Standard Diagnostics Incorporation, for the distribution and marketing SD Bioline Malaria Rapid Test Kits in Nigeria (including Tenders)....

a) SD Bioline Malaria Ag Pf – Detection of HRP-II Antigen of Plasmodium falciparum only.
HRP-II (Histidine Rich Protein II) is a water-soluble protein produced by trophozoites and young (but not mature) gametocytes of Plasmodium Falciparum (Pf).

o 99.7% sensitivity
o 99.5% specificity
o Detection: HRP-II Ag of P. falciparum
o No blood lyses and pre-processing
o Specimen : 5μl of whole blood
o Test result: in 15 minutes
o Interpretation: 2-Result line (Control / P.f)
o Suitable test for prevalence of Plasmodium falciparum
o Better detection at low-level of parasites than microscopic detection level.

b) SD Bioline Malaria Ag P.f/Pan

- P.f 99.7% / Pan 95.5% sensitivity
- 99.5% specificity
- Detection: HRP-II Ag of P. Falciparum and pLDH from other species (P.vivax, P. Malarie or P. Ovale.)
- No blood lyses and pre-processing
- Interpretation: 3-Result line (Control / P.f/ Pan)
- Advanced item for Malaria diagnosis
- Maximised sensitivity and specificity.
pLDH (parasite Lactase Dehydrogenase) is produced by asexual and sexual stages (gametocytes) of malaria parasites. Test kits currently available to detect pLDH from four Plasmodium species that infect human. They can distinguish P. Falciparum from the non-falciparum species, but cannot distinguish between P.vivax, P.ovale or P.malarie.

Quality Assured:

Both products successfully passed the quality tests at the WHO approved laboratory in LUTH Lagos (click the link) and we have commenced the registrations of both products with NAFDAC.

Standard Diagnostics Inc. (SD) is the global leader of in-vitro diagnostics and the SD Bioline Malaria products have already been successfully assessed by WHO. SD has tremendous experience in Malaria tenders in Africa. The company has recently won two tenders in Africa (4,900,000 tests in 2008 and 4,000,000 tests in 2009).

TRAINING Provided:

We will be partnering with the government in its education and training programme on Malaria and use of the rapid diagnostic kits. We have a 10 minutes training DVD below for the training of healthcare workers that are involved or keen to be involved in malaria management

BACKGROUND ON MALARIA:

Malaria is a life-threatening disease caused by parasites that are transmitted to people through the bites of infected mosquitoes.  A child dies of malaria every 30 seconds. There were 247 million cases of malaria in 2006, causing nearly one million deaths, mostly among African children.
The first point of call of most patients with ‘probable’ malaria case is often the local pharmacy store, where they will buy an anti-malaria drug and self-medicate themselves. This practice has often led to mismanagement, misdiagnosis and over-diagnosis of malaria.
The importance of accurate diagnosis of malaria is therefore of extreme importance. The current gold standard of diagnosis of malaria is a peripheral blood smear. However, trained staff and quality equipment and supervision are scarce within populations requiring such diagnosis. Microscopy is usually not available in most hospitals and where they are available, the test results are usually not readily available during first consultation, which means that patients are treated based on the symptoms before the test results are available.
Alternative methods of diagnosis are available, the simplest of which are Rapid Diagnostic Tests (RTDs). These are antigen detection tests which are simple to use and to interpret, and also use peripheral blood.
Global Fund, USAID & World Bank (Malaria Booster Programme) for example will be spending huge sum of money on RDTs in Nigeria over the new few years. But with over 140 million Nigerians having at least one case of malaria per year, the investments by these organisations will have to be supported by Federal, State & local governments.

Key facts
- Malaria is a life-threatening disease caused by parasites that are transmitted to people through the bites of infected mosquitoes. 
- A child dies of malaria every 30 seconds. 
- There were 247 million cases of malaria in 2006, causing nearly one million deaths, mostly among African children.
- Malaria is preventable and curable. 
- Approximately half of the world's population is at risk of malaria, particularly those living in lower-income countries. 
- Travellers from malaria-free areas to disease "hot spots" are especially vulnerable to the disease. 
- Malaria is commonly associated with poverty, but is also a cause of poverty and a major hindrance to economic development.
- Malaria takes an economic toll - cutting economic growth rates by as much as 1.3% in countries with high disease rates. Malaria’s health costs include both personal and public expenditures on prevention and treatment. In some heavy-burden countries, the disease accounts for:
- up to 40% of public health expenditures 
- 30% to 50% of inpatient hospital admissions 
- up to 60% of outpatient health clinic visits
- 9o% of malaria-related deaths occur in Sub-Saharan Africa.
- Non-immune pregnant women are at high risk of malaria. The illness can result in high rates of miscarriage and cause over 10% of maternal deaths (soaring to a 50% death rate in cases of severe disease) annually. 
- Semi-immune pregnant women risk severe anaemia and impaired fetal growth even if they show no signs of acute disease. An estimated 200 000 of their infants die annually as a result of malaria infection during pregnancy.
- HIV-infected pregnant women are also at increased risk. 
- There are over 140 million Nigerians at risk of malaria every year and it is estimated that about 50% of the adult population in Nigeria experience at least one episode yearly while the under five children have up to 2-4 attacks of malaria per year.

There are four types of human malaria:

• Plasmodium falciparum
• Plasmodium vivax
• Plasmodium malariae
• Plasmodium ovale.

Plasmodium falciparum and Plasmodium vivax are the most common. Plasmodium falciparum is the most deadly.
Plasmodium falciparum is the most lethal type of malaria in humans and it is the most common type of malaria in Nigeria (making up to 97% of all malaria cases in Nigeria).

TRANSMISSION

Malaria is naturally transmitted by the bite of a female Anopheles mosquito. When a mosquito bites an infected person, a small amount of blood is taken, which contains malaria parasites. These develop within the mosquito and about one week later, when the mosquito takes its next blood meal, the parasites are injected into the person being bitten with mosquito’s saliva. After a period of two weeks and several months (occasionally years) spent in the liver, the malaria parasites start to multiply within red blood cells, causing symptoms that include fever and headache. In severe cases the disease worsens leading to coma, and death.
Although many are under development, the challenge of producing a widely available vaccine that provides a high level of protection for a sustained period is still to be met.

SYMPTOMS

Symptoms of malaria include fever, shivering, arthralgia (joint pain), vomiting, anaemia (caused by haemolysis), haemoglobinura, retinal damage and convulsions. The classic symptom of malaria is cyclical occurrence of sudden coldness followed by rigour and then fever and sweating lasting four to six hours.
Malaria has been found to cause cognitive impairments, especially in children. It causes widespread anaemia during a period of rapid brain development and also direct brain damage. This neurologic damage results from cerebral malaria to which children are more vulnerable. Cerebral malaria is associated with retinal whitening, which may be a useful clinical sign in distinguishing malaria from other causes of fever.
Severe malaria is almost exclusively caused by P. falciparum infection and usually arises 6-14 days after infection. Consequences of severe malaria include coma and death if untreated - young children and pregnant women are especially vulnerable. In most severe cases of the disease, fatality rates can exceed 20%, even with intensive care treatment.

MALARIA IN NIGERIA

There are over 140 million people at risk of malaria every year in Nigeria and it is estimated that about 50% of the adult population in Nigeria experience at least one episode yearly while the under five children have up to 2 - 4 attacks of malaria annually.
The yearly economic loss due to malaria in Nigeria has been put at 132 Billion Naira due to costs of treatment and transport to source of treatment, loss of man-hours, absenteeism from schools and other indirect costs. Thus malaria imposes a heavy cost not only on a country’s income, but also on its rate of economic growth and invariably on its level of economic development.

DIAGNOSIS

Parasitological confirmation is essential in all suspected cases of malaria. However, where parasitological confirmation is not possible for reasons of implementation, especially in areas of high transmission such as Nigeria, highly vulnerable group including children under five years and in those with suspected severe malaria can be treated on clinical basis.
     a) Microscopy
Microscopy is the operational gold standard for the diagnosis of malaria. It is most cost-effective in situations where there is a high case load, a need for its use in the management of other diseases, in referral facilities managing severe malaria cases where species identification and parasite quantification is important for case and follow up, and where there is availability of skilled personnel to perform quality microscopy. In general, microscopy is appropriate at facilities with a functional laboratory and availability of trained personnel (microscopists), usually hospitals, large centres with inpatient care facilities, and tertiary care facilities.
    b) Rapid Diagnostic Test (RDT)
RDTs are based on the detection of circulating parasites antigens.
o Quality assured Histidine Rich Protein 11 (HRP2) based RDTs is recommended for the diagnosis of malaria in all age groups.
o Other available RDTs include Parasite Lactate Dehydrogenase (PLDH) and Aldolase. 

Comparison of Microscopy and Rapid Test

The current gold standard of diagnosis of malaria is a peripheral blood smear. However, trained staff and quality equipment and supervision are scarce within populations requiring such diagnosis. Alternative methods of diagnosis are available, the simplest of which are Rapid Tests. These are antigen detection tests which are simple to use and to interpret, and also use peripheral blood.

The objectives of the National Policy for Diagnosis & Treatment of Malaria include the deployment of RDTs to the following:

All levels of care where microscopy may not be possible due to lack of laboratory facilities or personnel.
o Secondary health facilities to compliment the use of microscopy
o Primary Health Care clinics and General Outpatient Clinics within tertiary health institutions.
Malaria can be eliminated as proven in United Arab Emirates, The Maldives and Tunisia. Recent data shows that large-scale use of WHO recommended strategies could rapidly reduce malaria, especially in areas of high transmission such as Africa. Country successes are due to intense national commitments and coordinated efforts with partners.