Dengue/Zika/Chikungunya Combo Rapid Test Cassette Infectious Disease Testing High Sensitivity Detection

Dengue/Zika/Chikungunya Combo Rapid Test Cassette
(Whole Blood/Serum/Plasma)

REF IDZC-445
A rapid test for the qualitative detection of antibodies to Dengue virus, Zika, Chikungunya virus in human whole blood, serum or plasma.
For professional in vitro diagnostic use only.
【INTENDED USE】
The Dengue/Zika/Chikungunya Combo Rapid Test Cassette (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Dengue virus, Zika, Chikungunya virus in human whole blood, serum or plasma.
【SUMMARY】
Zika virus (ZIKV), Chikungunya virus (CHIKV) and dengue virus (DENV) have similar epidemiology, transmission cycles in urban environments and clinical symptoms at onset (although complications vary markedly). They attracted interest in recent years due to their increasing incidence, expanding geographical range, possible effects caused by cocirculation and the unpredictable health threats and burden.1 More than 50% of the viruses in the genus Flavivirus, family Flaviviridae, cause disease in Humans. Flavivirus virions are small in size of 40–50nm, spherical with lipid envelopes, which contain a single-stranded, non-segmented RNA.1 The Dengue/Zika/Chikungunya Combo Rapid Test Cassette (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Dengue virus, Chikungunya, Zika virus in human whole blood, serum or plasma.
【PRINCIPLE】
The Dengue/Zika/Chikungunya Combo Rapid Test Cassette (Whole Blood/Serum/ Plasma) is a qualitative membrane-based immunoassay for the qualitative detection of antibodies to Dengue virus, Zika, Chikungunya virus in human whole blood, serum or plasma.
Dengue IgG/IgM Rapid Test
The membrane is pre-coated anti-human IgG and anti-human IgM on the test line region of the cassette. During testing, the specimen reacts with Dengue antigen-coated particles in the test cassette. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-human IgG or/and anti-human IgM on the membrane and generate a colored line. Presence of this colored line indicates a positive result, while its absence indicates 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.
Zika IgG/IgM Rapid Test
The membrane is pre-coated anti-human IgG and anti-human IgM on the test line region of the cassette. During testing, the whole blood, serum or plasma specimen reacts with recombinant Zika 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 colored line. Presence of this colored line indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
Chikungunya IgG Rapid Test
The membrane is pre-coated anti-human IgG 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 anti-human IgG on the membrane and generate a colored line. Presence of this colored line indicates a positive
result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
Chikungunya IgM Rapid Test
The membrane is pre-coated 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 anti-human IgM on the membrane and generate a colored line. Presence of this colored line indicates a positive
result, while its absence indicates a negative result. To serve as a procedural control, a colored 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 Dengue antigen conjugated gold colloid particles, Chikungunya antigen conjugated gold colloid particles, Zika antigen conjugated gold colloid particles and anti-human IgM, anti-human IgG coated on the membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only. Do not use after expiration date.
2. Do not eat, drink or smoke in the area where the specimens or kits are handled.
3. Do not use test if pouch is damaged.
4. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.
5. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
6. The used test should be discarded according to local regulations.
7. Humidity and temperature may adversely affect results.
【STORAGE AND STABILITY】
The kit can be stored at room temperature or refrigerated (2-30°C). The test 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】
 The Dengue/Zika/Chikungunya Combo Rapid Test Cassette (Whole Blood/Serum/ Plasma) can be performed using whole blood, 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 cassette by using a dropper or micropipette measuring 10µL. The dropper provided with the test dispenses approximately 10µL in one drop even if more blood is aspirated in the dropper.
 Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens.
 Testing should be performed immediately after specimen collection. 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 federal regulations for transportation of etiologic agents.
 EDTA K2, Heparin sodium, Sodium citrate and Potassium oxalate can be used as the anticoagulant for collecting the specimen.
【MATERIALS】
Materials provided
 Test cassettes
 Droppers
 Buffer
 Package insert
Materials required but not provided
 Specimen collection containers
 Centrifuge
 Micropipette
 Timer
 Lancets (for fingerstick whole blood only)
【DIRECTIONS FOR USE】
Allow the test cassette, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening. Remove the test cassette from the sealed pouch and use it within one hour.
2. Place the test cassette on a clean and level surface.
3. Hold the dropper vertically, draw the specimen about 1cm above the Fill Line, and transfer 1 full drop of specimen (approximately 10 µL) to each specimen well (S) of the test cassette, then add 2 drops of buffer (approximately 80 µL) into each buffer well (B) and start the timer.
4. Wait for the colored line(s) to appear. The test result should be read at 10 minutes. Do not interpret the result after 20 minutes.
Note: it is suggested not to use the buffer beyond 6 month after opening the vial.