Sample
Human serum or plasma (citrate, heparin).
Intended Use
The Malaria-Ab ELISA is intended for the qualitative determination of IgG/IgM antibodies against Plasmodium in human serum or plasma (citrate, heparin).
Contents of Kit
1.Microtiter Plate: 12 break-apart 8-well snap-off strips coated with recombinant Plasmodium antigens (P. falciparum, P. vivax); in resealable aluminium foil.
2.Conjugate: 1 bottle containing 20 ml of peroxidase labelled antibodies to human IgG/IgM in phosphate buffer (10 mM); colored blue; ready to use; black cap.
3.Positive Control: 1 vial containing 2 ml control; colored yellow; ready to use; red cap; ≤ 0.02% (v/v) MIT.
4.Negative Control: 1 vial containing 2 ml control; colored yellow; ready to use; blue cap; ≤ 0.0015% (v/v) CMIT/ MIT (3:1).
5.Cut-off Control: 1 vial containing 3 ml control; colored yellow; ready to use; green cap; ≤ 0.02% (v/v) MIT.
6.Sample Diluent: 1 bottle containing 100 ml of phosphate buffer (10 mM) for sample dilution; pH 7.2 ± 0.2; colored yellow; ready to use; white cap; ≤ 0.0015% (v/v) CMIT/ MIT (3:1).
7.TMB Substrate Solution: 1 bottle containing 15 ml 3,3',5,5'-tetramethylbenzidine (TMB), < 0.1 %; ready to use; yellow cap.
8.Wash Buffer (20× conc): 1 bottle containing 50 ml of a 20-fold concentrated phosphate buffer (0.2 M), pH 7.2 ± 0.2, for washing the wells; white cap.
9.Stop Solution: 1 bottle containing 15 ml sulphuric acid, 0.2 mol/L; ready to use; red cap.
10.1 Cover foil
11. 1 Instruction for use (IFU)
Storage
Store the kit at 2 - 8°C. The opened reagents are stable up to the expiry date stated on the label when stored at 2 - 8°C.
Performance Characteristics
The diagnostic sensitivity is defined as the probability of the assay of scoring positive in the presence of the specific analyte. It is 95.88% (95% confidence interval: 91.7% - 98.33%).
The diagnostic specificity is defined as the probability of the assay of scoring negative in the absence of the specific analyte. It is 97.53% (95% confidence interval: 94.97% - 99.0%).
General Description
Malaria is the most common tropical parasitic disease and is by now also of importance through returning travelers in non-endemic areas. The transmission of Plasmodium (P. ovale, P. malariae, P. vivax, P. falciparum) occurs by the bite of the Anopheles female mosquito. P. falciparum and P. vivax are the most common types.
The initial symptoms of infection are nonspecific (headache, fever, chills, dizziness, nausea) and may persist for several days. Several days or weeks later it comes to periodic fever attacks every 3 to 4 days depending on the species. For the Tropical Malaria these periodic phases are often not pronounced.
Especially at risk are children and non-immune adults from non-endemic areas (tourists from USA and Europe) as well as children from endemic areas between 6 months and 3 years of age. Adults in endemic regions develop a kind of resistance to malaria.
Alternative routes of infection are transplacentally, through blood transfusion or contaminated syringes among drug addicts.
Infection or presence of pathogen may be identified by:
1.Microscopy ("blood smear", Giemsa stain)
2.PCR
3.Serology: e.g. ELISA
Citations
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