Contents of Kit
1. Microplate wells: 12×8, coated with antigens: 12 microplate strips each containing 8 individual break-off wells in a frame, ready for use, STRIPS.
2. Additional control*: 5000 IU/l (IgG, human), ready for use, 1×2.0 ml, CAL 1, red coloured in decreasing intensity
3. Additional control*: 1000 IU/l (IgG, human), ready for use, 1×2.0 ml, CAL 2, red coloured in decreasing intensity
4. Calibrator: 250 IU/l (IgG, human), ready for use, 1×2.0 ml, CAL 3, red coloured in decreasing intensity
5. Additional control*: 50 IU/l (IgG, human), ready for use, 1×2.0 ml, CAL 4, red coloured in decreasing intensity
6. Positive control: 1×2.0 ml(IgG, human), ready for use, blue, POS CONTROL.
7. Negative control: 1×2.0 ml(IgG, human), ready for use, green, NEG CONTROL.
8. Enzyme conjugate: 1×12 ml, peroxidase-labelled anti-human IgG (rabbit), ready for use, green, CONJUGATE.
9. Sample buffer: 1×100 ml, ready for use, light blue, SAMPLE BUFFER.
10. 10× Wash buffer: 1×100 ml, 10× concentrate, colorless, WASH BUFFER 10×.
11. Chromogen/substrate: 1×12 ml, solution TMB/H2O2, ready for use, colorless, SUBSTRATE.
12. Stop solution: 1×12 ml, 0.5 M sulphuric acid, ready for use, colorless, STOP SOLUTION.
13. Test instruction
14. Quality control certificate
* Additional controls are included in the kit: positive (5000 IU/l and 1000 IU/l) and negative (50 IU/l). This kit is intended for qualitative detection and the values assigned are approximate values. The additional controls may be used optionally in addition to the positive and negative controls provided, but are not intended for calibration of the measurement.
Storage
Storage and stability: The test kit has to be stored at a temperature between +2°C and +8°C. Do not freeze. Unopened, all test kit components are stable until the indicated expiry date. All reagents must be brought to room temperature (+18°C to +25°C) approx. 30 minutes before use. After initial opening, the reagents are stable until the indicated expiry date if stored at +2 C to +8 C and protected from contamination, unless stated otherwise below.
Sensitivity
Specificity and sensitivity: 112 clinically characterized patient samples were examined with the Creative Diagnostics Anti-Measles Virus ELISA(lgG). The test showed a specificity and a sensitivity of 100% each.
Reference range: The levels of anti-measles virus antibodies (lgG) were analyzed with this Creative Diagnostics ELlSA in a panel of 500 healthy blood donors. With a cut-off of ratio 1.0, 94% of the blood donors were anti-measles viruses positive (lgG), which reflects the known percentage of infections in adults.
Note: It is recommended that each laboratory determine its own normal range based on the population and equipment used.
General Description
Clinical significance: The measles virus (MM) is the most instantly recognizable member of Morbilli-viruses, a group of viruses belonging to the Paramyxoviridae family. No animal reservoir is known. The measles virus causes an acute feverish illness which occurs mainly in childhood and is very infectious. In 1999, measles still caused worldwide 873,000 deaths per year. Today they are less frequent because of vaccination, especially in the westem hemisphere. However, measles epidemics are still observed in some countries. Individuals acutely infected with the virus exhibit a wide range of clinical symptoms ranging from a characteristic mild self-limiting infection to death.
MV infections are characterized by an incubation period of about 10 days, flu-like symptoms with fever, malaise, catarh of the upper respiratory tract, cough, congestion and conjunctivitis. Soon, after the measles rash, a typical exanthema, appears first near the ears, then on the forehead, in the face and over the rest of the body.
Complications arising from MV infections include secondary bacterial pneumonia, otitis media (approx. 1 %), encephalitis (approx. 1 %), myocarditis, miscarriage and a condition called subacute sclerosing panencephalitis (SSPE). Persistent MV infection of the otic capsule is an aetiologic factor in otosclerosis. Anti-measles lgG for the serological diagnosis of otoslcerotic hearing loss has a high specificity and sensitivity. SSPE is a progressive, generally fatal brain disorder caused by chronic measles virus infection. It occurs about 7 to 10 years after the infection and generally kills within 3 years from the onset of the symptoms. The patients suffer from behavioral changes, cognitive deterioration, vision problems and eventually advanced neurological symptoms, such as severe spasms, and finally severe physical and mental impairment that leads to death. Males are more commonly affected than females. The risk of SSPE from measles was underestimated according to older data. Current papers put it at closer to 6.5 to 11 cases of SsPE per 100,000 measles infections; that means 7 to 13 times higher than the earlier estimates.
Antibodies against MV can be found in the serum of almost all patients during and after a measles infection. MV infections often cause an increase in heterologic antibodies. The statistically evaluated detection rate for antibodies is significantly higher for ELISA and IlFT in comparison with e.g. neutralisation tests. Antibodies against MV are reliable markers to confim suspected measles infections.
Antigen: The antigen source is provided by inactivated cell lysates of Vero cells infected with the "Edmonston" strain of measles virus.
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