SD Malaria P.f/P.v Antigen Test STANDARD DIAGNOSTICS, INC. ISO 9001 Certified Company SD Malaria P.f/P.v Antigen Test STANDARD DIAGNOSTICS, INC.

ISO 9001 Certified Company What is Malaria ? Anopheles Mosquito 1. Malaria is caused by a protozoan (Plasmodium sp.) which invades human red blood cells 2. The parasite is usually transmitted to humans by the bite of the female Anopheles mosquito

Where is Malaria ? 1. 90 countries worldwide ISO 9001 Certified Company Where is Malaria ? 1. 90 countries worldwide 2. Almost 85% of the world's malaria occurs in sub-Saharan Africa. 3. Malaria is also prevalent in Southeast Asia, India, South and Central America

How suffered? - Fatal, parasitic disease characterized ISO 9001 Certified Company How suffered? - Fatal, parasitic disease characterized by fever, chills, and anemia - Over 500 million clinical cases and 2.7 million malaria-caused deaths per year [A young mother who has bought her sick child – Uganda]

SD Malaria P.f/P.v Ag Test ISO 9001 Certified Company SD Malaria P.f/P.v Ag Test Rapid Test Detection of pLDH ELISA Kit pLDH RBC Antibody to pLDH

SD Malaria P.f/P.v Ag Rapid Test ISO 9001 Certified Company SD Malaria P.f/P.v Ag Rapid Test Rapid and Easy Detection of all forms of human malaria Differentiation between P. f /P. v Direct Sandwich Method: Ab-Ag-Ab Ability to monitor of drug-therapy

Differentiation between P. f /P. v ISO 9001 Certified Company Differentiation between P. f /P. v pLDH is isoenzyme of all Plasmodium species. Use of P.f/P.v Pan Antibody and P.f specific antibody to pLDH  Able to differentiate between P.f/P.v Disable to differentiate  Why? The HRP-2 only exists in P.f pLDH HRP-2

Easy test procedure of Rapid test ISO 9001 Certified Company Easy test procedure of Rapid test 1. 1 drop of Assay Buffer into the Conjugate Well 2. 4 drops of Assay Buffer into the Washing Well 3. Add 20µl of blood the Conjugate Well 4. Place the Dipstick vertically into the Conjugate Wells 5. Transfer the Dipstick from the conjugate Wells to the Washing Wells 6. Read the results

Interpretation of the result ISO 9001 Certified Company Interpretation of the result P. falciparum + P. vivax + or P. malariae + or P. ovale + Negative Invalid

SD Malaria P.f/P.v pLDH Ag ELISA Kit ISO 9001 Certified Company SD Malaria P.f/P.v pLDH Ag ELISA Kit The First ELISA kit in the World The Only Malaria Ag ELISA in the World Direct Sandwich Method: Ab-Ag-Ab Ability to monitor of drug-therapy Excellent detection limit 10 ~50 parasites/ul Reliable alternative to Microscopy

Easy test procedure of ELISA Kit ISO 9001 Certified Company Easy test procedure of ELISA Kit ⇒ The SD Malaria P.f/P.v Ag ELISA contains two microplates. - One is uncoated for lysis of whole blood, - The other is pre-coated with mouse pLDH antibody on well. ⇒ After lysing whole blood in uncoated well, The test is performed as like a general ELISA kit

Comparison of test method regarding to No. of parasite ISO 9001 Certified Company Comparison of test method regarding to No. of parasite

Comparison of test method regarding to No. of parasite ISO 9001 Certified Company Comparison of test method regarding to No. of parasite

Comparison of test method regarding to No. of parasite ISO 9001 Certified Company Comparison of test method regarding to No. of parasite

Comparison of test method ISO 9001 Certified Company Comparison of test method No. of Positive No. of Negative Sensitivity(%) Specificity(%) Microscopic Exam. 200 SD ELISA kit 194 197 97.0% 98.5% SD Rapid test 181 196 90.5% 98.0% A Rapid A (Detection for pLDH) 179 198 89.5% 99.0% A Rapid B (Detection for HRP-2) 172 86.0%