(Whole Blood/Serum/Plasma) Package Insert |
CHIK01 |
| A rapid test for the qualitative detection of IgG and IgM antibodies
to Chikungunya in human whole blood, serum or plasma specimens. For professional in vitro diagnostic use only. |
| INTENDED USE The Chikungunya IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Chikungunya in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with CHIK. Any reactive specimen with the Chikungunya IgG/IgM Rapid Test must be confirmed with alternative testing method(s) and clinical findings. SUMMARY Chikungunya is a rare viral infection transmitted by the bite of an infected Aedes aegypti mosquito. It is characterized by a rash, fever, and severe joint pain (arthralgias) that usually lasts for three to seven days. The name is derived from the Makonde word meaning ‘that which bends up’ in reference to the stooped posture developed as a result of the arthritic symptoms of the disease. It occurs during the rainy season in tropical areas of the world, primarily in Africa, South-East Asia, Southern India and Pakistan.1.2 The symptoms are most often clinically indistinguishable form those observed in dengue fever. Indeed, dual infection of dengue and chikungunya has been reported in India.3 Unlike dengue, hemorrhagic manifestations are relatively rare and most often the disease is a self limiting febrile illness. Therefore it is very important to clinically distinguish dengue from CHIK infection. CHIK is diagnosed based on serological analysis and viral isolation in mice or tissue culture. An IgM immunoassay is the most practical lab test method.4 PRINCIPLE The Chikungunya IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of IgG and IgM antibodies to Chikungunya in whole blood, serum or plasma. The membrane is pre-coated mouse anti-human IgG and mouse anti-human IgM on the test line region of the cassette. During testing, the whole blood, serum or plasma specimen reacts with recombinant Chikungunya antigen conjugated colloid gold. The mixture migrates upward on the membrane chromatographically by capillary action to react with mouse anti-human IgG or/and mouse anti-human IgM on the membrane and generate a coloured line. Presence of this coloured line indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a coloured line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. REAGENTS The test cassette contains recombinant Chikungunya antigen conjugated colloid gold, mouse anti-human IgG and mouse anti-human IgM coated on the membrane. PRECAUTIONS |
| • | For professional in vitro diagnostic use only. Do not use after expiration date. |
| • | Do not eat, drink or smoke in the area where the specimens or kits are handled. |
| • | Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. |
| • | Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed. |
| • | Humidity and temperature can adversely affect results. |
| STORAGE AND STABILITY The kit can be stored at room temperature or refrigerated (2-40°C). The test cassette is stable through the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date. SPECIMEN COLLECTION AND PREPARATION |
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| • | The Chikungunya IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or fingerstick), serum or plasma. | ||
| • | To collect Fingerstick Whole Blood specimens: | ||
| ⚬ | Wash the patient's hand with soap and warm water or clean with an alcohol swab. 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. | ||
| ⚬ | Add the Fingerstick Whole Blood specimen to the test by using a dropper: | ||
| * | Touch the end of the dropper to the drop of blood and draw up approximately 40µL. Avoid air bubbles. | ||
| * | Then squeeze the bulb to dispense the whole blood into the specimen well of the cassette. | ||
| • | Separate the serum or plasma from blood as soon as possible to avoid hemolysis. Only clear, non-hemolyzed specimens can be used. | ||
| • | 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 may be stored at 2-8°C for up to 3 days, for long term storage, specimens should be kept below -20°C. 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. | ||
| • | Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly. | ||
| • | If specimens are to be shipped, they should be packed in compliance with regulations for transportation of etiologic agents. | ||
MATERIALS Materials provided • Test cassettes • Droppers • Buffer • Package insert • Lancets (for fingerstick whole blood only) • Alcohol Swabs Material/s required but not provided • Specimen collection containers • Centrifuge (for plasma & serum) • Timer • Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only) |
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| DIRECTIONS FOR USE Allow test cassette, specimen, and/or controls to equilibrate to room temperature (15-40°C) prior to testing. |
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| 1. | Remove the test cassette from the sealed pouch and use it as soon as possible. | |
| 2. | Place the cassette on a clean and level surface. | |
| Serum or Plasma specimen: Hold the dropper vertically and
transfer 1 drop of serum or plasma (approximately 40µL) to the specimen area, then add 2 drops of buffer (approximately
80µL),and start the timer, see illustration below. For Whole Blood specimen: Hold the dropper vertically and transfer 1 drop of whole blood (approximately 40µL) to the specimen area, then add 2 drops of buffer (approximately 80µL), and start the timer. See illustration below. |
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| 3. | Wait for the coloured line(s) to appear. Read the result at 15 minutes, do not interpret the result after 20 minutes. | |
 INTERPRETATION OF RESULTS IgG POSITIVE: Two distinct coloured lines appear. One colour line should be in the control region (C) and another colour line should be in the IgG region. IgM POSITIVE: Two distinct coloured lines appear. One colour line should be in the control region (C) and another colour line should be in the IgM region. IgG and IgM POSITIVE: Three distinct coloured lines appear. One colour line should be in the control region (C) and another two colour lines should be in the IgG and IgM region. NOTE: The intensity of the colour in the test line region (T) will vary depending on the concentration of Chikungunya antibodies present in the specimen. Therefore, any shade of red in the test region should be considered positive. NEGATIVE: One colour line appears in the control region (C). No apparent red or pink line appears in the IgG and IgM region. INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor. QUALITY CONTROL Internal procedural controls are included in the test. A colour line appearing in the control region (C) is an internal positive procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance. LIMITATIONS |
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| 1. | The Direction for Use and the Interpretation of Result must be followed closely when testing for the presence of antibodies to Chikungunya in serum, plasma or whole blood from individual subjects. Failure to follow the procedure may give inaccurate results. |
| 2. | The Chikungunya IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is limited to the qualitative detection of antibodies to Chikungunya in human serum, plasma or whole blood. The intensity of the test band does not have linear correlation with antibody titer in the specimen. |
| 3. | A negative result for an individual subject indicates absence of detectable Chikungunya antibodies. However, a negative test result does not preclude the possibility of exposure to Chikungunya. |
| 4. | A negative result can occur if the quantity of Chikungunya antibodies present in the specimen is below the detection limits of the assay, which a sample is collected. |
| 5. | The results obtained with this test should only be interpreted in
conjunction with other diagnostic procedures and clinical findings. |
EXPECTED VALUES The Chikungunya IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) has been compared with a leading commercial Chikungunya IgG/IgM ELISA test. The correlation between these two systems is at least 92%. PERFORMANCE CHARACTERISTICS A total of 93 samples from susceptible subjects were tested by the Chikungunya IgG/IgM Rapid Test Cassette and by a commercial Chikungunya IgM ELISA kit. Comparison for all subjects is shown in the following table.  Relative sensitivity: 90.3% (95%CI:*81.0%-96.0%) Relative specificity: >99.9% (95%CI:*86.7%-100%) Accuracy: 92.5% (95%CI:*85.1%-96.9%) *Confidence Intervals A total of 68 samples from susceptible subjects were tested by the Chikungunya IgG/IgM Rapid Test Cassette and by a commercial Chikungunya IgG ELISA kit. Comparison for all subjects is shown in the following table.  Relative sensitivity: 94.3% (95%CI:*80.8%-99.3%), Relative specificity: 97.0% (95%CI:*84.2%-99.9%) Accuracy: 95.6% (95%CI:*87.6%-99.1%) *Confidence Intervals |
