A rapid chromatographic immunoassay intended for the qualitative detection of IgG/IgM antibodies to measles antigen in human whole blood, serum or plasma specimen. For professional in vitro diagnostic use only.
【INTENDED USE】
The Measles IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG/IgM antibodies to measles in human whole blood, serum or plasma specimen.
【SUMMARY】
Measles is a highly contagious viral disease characterized by a clinically distinct prodrome of fever, coryza, conjunctivitis, cough and a pathognomic exanthem (Koplik’s spots). The rash of Measles appears after a 3 to 5 days prodrome, some 14 days after exposure and may be associated with edema of the skin. The disease is the result of infection with the Measles Virus, genus Morbillivirus of the family Paramyxoviridae.
Complications are: otitis media, pneumonia and encephalitis. The virus infects the respiratory tract, and then spreads throughout the body. Measles is a human disease and is not known to occur in animals. Before the introduction of measles vaccine in 1963 and widespread vaccination, major epidemics occurred approximately every 2-3 years and measles caused an estimated 2.6 million deaths each year. The disease remains one of the leading causes of death among young children globally, despite the availability of a safe and effective vaccine.1
【PRINCIPLE 】
The Measles IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to measles in whole blood, serum or plasma specimen. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with measles antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to measles. A colored line will appear in IgG test line region as a result of this. Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM antibodies to measles, the conjugate-specimen complex reacts with anti-human IgM. A colored line appears in IgM test line region as a result. Therefore, if the specimen contains measles IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains measles IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain measles antibodies, no colored line will appear in either of the test line regions,
indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
【REAGENTS】
The test contains anti-human IgM and anti-human IgG as the capture reagent, measles antigen as the detection reagent. A goat anti-rabbit IgG is employed in the control line system.
【PRECAUTIONS】
For in vitro diagnostic use only. Do not use after the expiration date.
Do not smoke, drink or eat in areas where specimens or kits reagents are handled.
Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are being tested.
Humidity and temperature can adversely affect results.
The used test should be discarded according to local regulations.
【STORAGE AND STABILITY】
Store as packaged in the sealed pouch either at room temperature or refrigerated (2- 30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the expiration date.
【SPECIMEN COLLECTION AND PREPARATION】
The Measles IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) can be performed using whole blood, serum or plasma.
1. To Collect Fingerstick Whole Blood:
Wash the patient’s hand with soap and warm water or clean with an alcohol pad. Allow to dry.
Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
2. To Collect Venipuncture Whole Blood:
Collect venipuncture whole blood specimen into a collection tube containing EDTA-K2, sodium citrate, heparin sodium and potassium oxalate. Do not use hemolyzed blood for testing. Mix whole blood by inversion and use in the test as outlined in the Test Procedure.
3. To collect Plasma/Serum:
Step 1:
Collect venipuncture blood specimen into collection tube containing EDTA-K2, sodium citrate, heparin sodium and potassium oxalate for plasma or collection tube without anticoagulants for serum.
Step 2:
To prepare plasma specimen, centrifuge collected specimens and carefully transfer the plasma into a new pre-labeled tube.
To prepare serum specimen, allow blood to clot, centrifuge collected specimens and carefully transfer the serum into a new pre-labeled tube.
4. Testing should be performed immediately after the specimens have been collected.
Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens can be stored at 2-8°C for up to 3 days and -20°C for 12 months. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
5. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. It is recommended not to freeze and thaw more than 3 times in both serum and plasma specimens.
6. If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.
【MATERIALS】
Materials provided
• Test cassettes
• Package insert
• Droppers
• Buffer
Materials required but not provided
• Centrifuge
• Timer
• Pipette
• Specimen collection containers • Lancets • Alcohol pad
【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Place the cassette on a clean and level surface.
For Serum or Plasma:
Use a dropper: Hold the dropper vertically and transfer 1 full drop of serum or plasma (approximately 10μL) to the specimen well(S), then add 2 drops of buffer (approximately 80µL) and start the timer.
Use a pipette: To transfer 10µL of serum or plasma to the specimen well(S), then add 2 drops of buffer (approximately 80µL) and start the timer.
For Whole Blood (Venipuncture/Fingerstick):
Use a dropper: Hold the dropper vertically, transfer 2 full drops of whole blood (approximately 20μL) to the specimen well(S), then add 2 drops of buffer (approximately 80µL) and start the timer.
Use a pipette: To transfer 20µL of whole blood to the specimen well(S), then add 2 drops of buffer (approximately 80µL) and start the timer.
3. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.
Note: Once the buffer vial is opened, please make sure the kit to be used up within 6 months.
