Dengue Rapid Test Cassette and use it within one hour.

and use it within one hour. In the majority of the cases, this is accompanied by elevated levels of IgM.5
2. Place the test cassette on a clean and level surface. The Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) has been compared with a leading
(Whole Blood/Serum/Plasma)  For Serum or Plasma Specimens: commercial Dengue ELISA test, demonstrating sensitivity of 83.3% for IgM in primary infection and
 To use a dropper: Hold the dropper vertically, draw the specimen up to the Fill Line 98.4% for IgG in secondary infection.
Package Insert (approximately 5μl), and transfer the specimen to the specimen well (S) of the test cassette , 【PERFORMANCE CHARACTERISTICS】
REF IDEN-402 English then add 3 drops of buffer (approximately 120 µl) into the buffer well (B) and start the timer. Sensitivity and Specificity
A rapid test for the qualitative detection of antibodies (IgG and IgM) to Dengue virus in whole blood, Avoid trapping air bubbles in the specimen well (S). The Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) has been evaluated with specimens
serum, or plasma.  To use a micropipette: Pipette and dispense 5 µl of specimen to the specimen well (S) of the test obtained from a population of symptomatic and asymptomatic individuals. Results were confirmed by a
For professional in vitro diagnostic use only. cassette, then add 3 drops of buffer (approximately 120 µl) into the buffer well (B) and start the leading commercial Dengue ELISA test.
【INTENDED USE】 timer. The results show that the overall relative sensitivity for the primary and secondary infection of the Dengue
The Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic  For Whole Blood (Venipuncture/Fingerstick) Specimens: Rapid Test Cassette (Whole Blood/Serum/Plasma) is 94.3%, and the relative specificity is 99.1%,and the
immunoassay for the qualitative detection of IgG and IgM antibodies to Dengue virus in human whole  To use a dropper: Hold the dropper vertically, draw the specimen about 1cm above the Fill Line, relative accuracy is 98.3%.
blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections. and transfer 1 drop of whole blood (approximately 10 µl) to the specimen well (S) of the test Dengue Primary Infection for IgM/IgG test results
【SUMMARY】 cassette, then add 3 drops of buffer (approximately 120 µll) into the buffer well (B) and start the Method ELISA
Dengue is a flavivirus, transmitted by Aedes aegypti and Aedes albopictus mosquitoes. It is widely timer. Positive
distributed throughout the tropical and subtropical areas of the world, 1 and causes up to 100 million  To use a micropipette: Pipette and dispense 10 µl of whole blood to the specimen well (S) of the Results
IgM IgG
negative
infections annually.2 Classic Dengue infection is characterized by a sudden onset of fever, intense test cassette, then add 3 drops of buffer (approximately 120ul) into the buffer well (B) and start Dengue Rapid Test Cassette
IgM 20 0 0
headache, myalgia, arthralgia and rash. Primary Dengue infection causes IgM antibodies to increase to a the timer. (Whole Blood/ Serum/Plasma) Positive
IgG 4 0 0
detectable level in 3 to 5 days after the onset of fever. IgM antibodies generally persist for 30 to 90 days. 3 3. Wait for the colored line(s) to appear. The test result should be read at 10 minutes. Do not interpret
Most Dengue patients in endemic regions have secondary infections, 4 resulting in high levels of specific the result after 20 minutes. Negative 0 0 0
IgG antibodies prior to or simultaneous with IgM response. 5 Therefore, the detection of specific Note: it is suggested not to use the buffer,beyond 6 month after opening the vial. Relative Sensitivity 83.3% / /
anti-Dengue IgM and IgG antibodies can also help to distinguish between primary and secondary Dengue Secondary Infection for IgM/IgG test results
infections. Method ELISA
The Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test that utilizes a combination Positive
of Dengue antigen coated colored particles for the detection of IgG and IgM Dengue antibodies in human Results negative
Dengue Rapid Test IgM IgG
whole blood, serum, or plasma. Cassette (Whole Blood/ IgM 46 1 0
【PRINCIPLE】 Serum/Plasma) Positive
The Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane-based IgG 18 63 0
immunoassay for the detection of Dengue antibodies in whole blood, serum, or plasma. This test consists Negative 0 0 0
of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is Relative Sensitivity 71.9% 98.4% /
coated in IgG test line region. During testing, the specimen reacts with Dengue antigen-coated particles in Non-Dengue Infection for IgM/IgG test results
the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary Method ELISA
action and reacts with the anti-human IgG in IgG test line region. If the specimen contains IgG antibodies Positive
to Dengue, a colored line will appear in IgG test line region. In the IgM component, anti-human IgM is Results negative
Dengue Rapid Test IgM IgG
coated in IgM test line region. During testing, the specimen reacts with anti-human IgM. Dengue IgM Cassette (Whole Blood/ IgM 0 0 1
antibodies, if present in the specimen, reacts with the anti-human IgM and the Dengue antigen-coated Serum/Plasma) Positive
particles in the test cassette, and this complex is captured by the anti-human IgM, forming a colored line IgG 0 0 3
in IgM test line region. Negative 0 0 429
Therefore, if the specimen contains Dengue IgG antibodies, a colored line will appear in IgG test line Relative Specificity / / 99.1%
region. If the specimen contains Dengue IgM antibodies, a colored line will appear in IgM test line region. Relative sensitivity: (20+63)/ (24+64) =94.3% (95%CI*: 87.2%~98.1%);
If the specimen does not contain Dengue antibodies, no colored line will appear in either of the test line 【INTERPRETATION OF RESULTS】 Relative specificity: 429/433=99.1% (95%CI*: 97.7%~99.7%);
regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in (Please refer to the illustration above) Accuracy: (20+63+429)/ (24+64+433) =98.3% (95%CI*: 96.7%~99.2%). *Confidence Intervals
the control line region, indicating that the proper volume of specimen has been added and membrane IgG and IgM POSITIVE:* Three colored lines appear. One colored line should be in the control line Precision
wicking has occurred. region (C), and two colored lines should appear in IgG test line region and IgM test line region. The color Intra-Assay
【REAGENTS】 intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies indicated end Within-run precision has been determined by using 15 replicates of four specimens: a negative, an IgG
The test cassette contains Dengue antigen conjugated gold colloid particles and anti-human IgM, stage of primary Dengue infection and early stage of secondary Dengue infection . positive, an IgM positive and an IgG/IgM dual positive. The specimens were correctly identified >99% of
anti-human IgG coated on the membrane. IgG POSITIVE:* Two colored lines appear. One colored line should be in the control line region (C), and the time.
【PRECAUTIONS】 a colored line appears in IgG test line region. The result is positive for Dengue virus specific-IgG and is Inter-Assay
 For professional in vitro diagnostic use only. Do not use after expiration date. probably indicative of secondary Dengue infection. Between-run precision has been determined by 15 independent assays on the same four specimens: a
 Do not eat, drink or smoke in the area where the specimens or kits are handled. IgM POSITIVE:* Two colored lines appear. One colored line should be in the control line region (C), negative, an IgG positive, an IgM positive and an IgG/IgM dual positive. Three different lots of the Dengue
 Handle all specimens as if they contain infectious agents. Observe established precautions against and a colored line appears in IgM test line region. The result is positive for Dengue virus specific-IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) have been tested using these specimens. The
microbiological hazards throughout the procedure and follow the standard procedures for proper antibodies and is indicative of primary Dengue infection. specimens were correctly identified >99% of the time.
disposal of specimens. *NOTE: The intensity of the color in the IgG and/or IgM test line region(s) will vary depending on the Cross-reactivity
 Wear protective clothing such as laboratory coats, disposable gloves and eye protection when concentration of Dengue antibodies in the specimen. Therefore, any shade of color in the IgG and/or IgM The Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg,
specimens are assayed. test line region(s) should be considered positive. HBsAb, HBeAg, HBeAb, HBcAb, Syphilis, HIV, HCV, H. Pylori, MONO, CMV, Rubella and TOXO positive
 Humidity and temperature can adversely affect results. NEGATIVE: One colored line should be in the control line region (C). No line appears in IgG and IgM specimens. The results showed no cross-reactivity.
【STORAGE AND STABILITY】 test line region(s). Interfering Substances
The kit can be stored at room temperature or refrigerated (2-30°C). The test cassette is stable through the INVALID: Control line fails to appear. Insufficient buffer volume or incorrect procedural techniques are The following potentially interfering substances were added to Dengue negative and positive specimens.
expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new Acetaminophen: 20 mg/Dl Caffeine: 20 mg/dL
DO NOT FREEZE. Do not use beyond the expiration date. test cassette. If the problem persists, discontinue using the test kit immediately and contact your local Acetylsalicylic Acid: 20 mg/dL Gentisic Acid: 20 mg/dL
【SPECIMEN COLLECTION AND PREPARATION】 distributor. Ascorbic Acid: 2g/dL Albumin: 2 g/dL
 The Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) can be performed using whole blood, 【QUALITY CONTROL】 Creatin: 200 mg/dL Hemoglobin 1000mg/dL
serum, or plasma. An internal procedural control is included in the test. A colored line appearing in the control line region (C) Bilirubin: 1g/dL Oxalic Acid: 60mg/dL
 To collect Fingerstick Whole Blood Specimens: is an internal valid procedural control, confirming sufficient buffer volume and adequate membrane None of the substances at the concentration tested interfered in the assay.
 Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry. wicking. 【BIBLIOGRAPHY】
 Massage the hand without touching the puncture site by rubbing down the hand towards the Control standards are not supplied with this kit; however, it is recommended that positive and negative 1. Halstead SB, Selective primary health care: strategies for control of disease in the developing world:
fingertip of the middle or ring finger. controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test XI, Dengue. Rev. Infect. Dis. 1984; 6:251-264
 Puncture the skin with a sterile lancet. Wipe away the first sign of blood. performance. 2. Halstead SB, Pathogenesis of dengue: challenges to molecular biology. Science 1988; 239:476-481
 Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the 【LIMITATIONS】 3. Ruechusatsawat K, et al. Daily observation of antibody levels among dengue patients detected by
puncture site. 1. The Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The enzyme-linked immunosorbent assay (ELISA). Japanese J. Trop. Med. Hygiene 1994; 22: 9-12
 Add the Fingerstick Whole Blood specimen to the test cassette by using a dropper or micropipette test should be used for the detection of Dengue antibodies in whole blood, serum or plasma 4. Lam SK. Dengue haemorrhagic fever. Rev. Med. Micro. 1995; 6:39-48
measuring 10ul. The dropper provided with the test dispenses approximately 10ul in one drop specimens only. Neither the quantitative value nor the rate of increase in Dengue antibody 5. Dengue haemorrhagic fever: diagnosis, treatment, prevention and control. 2nd edition. Geneva: World
even if more blood is aspirated in the dropper. concentration can be determined by this qualitative test. Health Organization
 Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, 2. The Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) will only indicate the presence of 6. Yamada K, et al. Antibody responses determined for Japanese dengue fever patients by neutralization
non-hemolyzed specimens. Dengue antibodies in the specimen and should not be used as the sole criteria for the diagnosis of and hemagglutination inhibition assays demonstrate cross-reactivity between dengue and Japanese
 Testing should be performed immediately after specimen collection. Do not leave the specimens at Dengue. encephalitis viruses. Clin Diagn Lab Immunol. 2003 Jul; 10(4): 725-8.
room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up 3. In the early onset of fever, anti-Dengue IgM concentrations may be below detectable levels. For 7. Dobler G, et al. Cross reactions of patients with acute dengue fever to tick-borne encephalitis. Wien
to 3 days. For long-term storage, specimens should be kept below -20°C. Whole blood collected by primary infection, an IgM antibody-capture enzyme-linked immunosorbent assay (MAC-ELISA) Med Wochenschr (in German). 1997; 147(19-20): 463-4
venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze showed that 80% of the Dengue patients tested exhibited detectable levels of IgM antibody by the fifth 8. Makino Y, et al. Studies on serological cross-reaction in sequential flavivirus infections. Microbiol
whole blood specimens. Whole blood collected by fingerstick should be tested immediately. day after infection, and 99% of the patients tested IgM positive by day 10. It is recommended that Immunol. 1994; 38(12): 951-5.
 Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed patients be tested within this time. For the secondary infection, a low molar fraction of anti-Dengue IgM Index of Symbols
and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly. and a high molar fraction of IgG that is broadly reactive to flaviviruses characterize the antibodies. 5
 If specimens are to be shipped, they should be packed in compliance with federal regulations for The IgM signal may be faint and the cross reaction in the region of IgG line may appear. Attention, see
Tests per kit
Authorized
transportation of etiologic agents. 4. Serological cross-reactivity across the flavivirus group (Dengue 1, 2, 3 & 4, St. Louis encephalitis, instructions for use Representative
 EDTA K2, Heparin sodium, Sodium citrate and Potassium oxalate can be used as the anticoagulant for West Nile virus, Japanese encephalitis and yellow fever viruses) is common. 6,7,8 Positive results
For in vitro
collecting the specimen. should be confirmed by other means. Use by Do not reuse
【MATERIALS 】 5. The continued presence or absence of antibodies cannot be used to determine the success or failure diagnostic use only
Materials provided of therapy.
 Test Cassettes  Droppers 6. Results from immunosuppressed patients should be interpreted with caution. Store between 2-30°C Lot Number Catalog #
 Buffer  Package insert 7. As with all diagnostic tests, all results must be interpreted together with other clinical information
Materials required but not provided available to the physician. Do not use if package is Consult Instructions For
 Specimen collection containers  Centrifuge (for plasma only) 8. If the test result is negative and clinical symptoms persist, additional testing using other clinical damaged
Manufacturer
Use
 Micropipette  Timer methods is recommended. A negative result does not at any time preclude the possibility of Dengue
 Lancets (for fingerstick whole blood only) infection.
【DIRECTIONS FOR USE】 9. The hematocrit of the whole blood should be between 25% and 65%.
Allow the test cassette, specimen, buffer, and/or controls to reach room temperature (15-30°C) 【EXPECTED VALUES】
prior to testing. Primary Dengue infection is characterized by the presence of detectable IgM antibodies 3-5 days after the
1. Bring the pouch to room temperature before opening. Remove the test cassette from the sealed pouch onset of infection. Secondary Dengue infection is characterized by the elevation of Dengue-specific IgG. Number: 146054600
Effective date: 2019-05-31