Dengue IgM ELISA
INTENDED USE
The Dengue IgM ELISA is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of anti-
dengue virus (DEN1, 2, 3, 4) IgM in human serum or plasma. It is intended for healthcare professional use only as an
aid in the diagnosis of acute infection with dengue virus.
| Product details |
Description |
| Delivery |
Within 48 hours |
| Packaging Specifications |
8 x 12 strips, 96 wells |
| Country Of Origin |
China |
| Manufacturer |
18 months |
| Preservation method |
2℃-8℃ |
| Specimen |
Whole blood |
| Assification |
class1 |
| Type |
Elisa Test Kit |
SPECIMEN COLLECTION AND PREPARATION
1.Serum or plasma should be prepared from a whole blood specimen obtained by acceptable venipuncture technique.
2.This kit is designed for use with serum or plasma specimens without additives only.
3.If a specimen is not tested immediately, refrigerate at 2-8°C for up to 3 days. For storage longer than 3 days, the
specimen should be frozen at -20°C. Avoid multiple freeze-thaw cycles. If a specimen is to be shipped, pack in
compliance with federal regulations covering the transportation of etiologic agents.
4.Specimens containing precipitates may give inconsistent test results. Clarify such specimens by centrifugation prior
to performing the assay.
5.Do not use specimens demonstrating gross lipemia, gross hemolysis or turbidity. Do not use specimens containing
sodium azide.
PREPARATION OF THE REAGENTS PRIOR TO ASSAYING
1. Bring all reagents and controlsto room temperature (18-28°C).
2. Preparation of working Wash Buffer:
If precipitants are visible, warm up the Wash Buffer (20X ) at 37˚C.Dilute concentrated Wash Buffer (20X) at the rate of 1:20
dilution with distilled water.
TEST PROCEDURE
1.Calculate the desired number of microwells. Remove the remaining microwells and place them with desiccant into the
resealable plastic bag, seal and store at 2-8°C for later use.
2.Add specimens:
2. 1 Blank well: Do not add reagents.
2. 2 Control wells: Add 100 µL Positive Control and Negative Control into the designated control wells.
2.3 Test wells: Add 100 uL Sample Diluent to the test wells, then add 5 uL sample in the corresponding well.
2.4 Gently shake the plate for 20 seconds, and then cover the plate with the sealer.
3. Incubate:Incubate the plate at 37°C for 20 minutes.
4. Wash Step (Can be performed manually or with automated washing):
Manual washing: Carefully remove the incubation mixture by disposing of the solution into a waste container. Fill each
well with 350 µL diluted wash buffer and shake gently for 20-30 seconds. Discard the wash solution completely. Repeat 4
more times. After completing the last wash step, tap the plate on absorbent paper to remove residual liquid.
Automated washing: Automatic plate washer must be calibrated to ensure efficient washing. Fill each well with 350 µL
diluted wash buffer and soak for 20-30 seconds. Aspirate all wells completely. Repeat 4 more times.
5. Conjugate: Add 100 μL conjugate into each well except the Blank Well.
6. Incubate: Cover the wells and incubate at 37°C for 60 minutes.
7. Wash Step: Wash the plate 5 times as described in step 4.
8. Substrate: Add 50 µL of Substrate A and 50 µL of Substrate B into each well, including the Blank Well. Gently shake the
microwellsfor 20 seconds. Incubate at 37°C in the dark for 15 minutes.
9. Stop Solution: Add 50 μL Stop Solution to each well.A yellow color should develop in wells containing Positive specimens.
10. Read Results: Read at 450/630-700 nm within 30 minutes.
Note: Microplate can also be read at 450 nm, but it isstrongly recommended to read it at 450/630-700 nm for better results
Storage
• Store at 2-8℃.
• Place unused wells in the zip-lock aluminum foiled pouch and return to 2-8 °C, under which conditions the wells will remain stable for 2 months, or until the labeled expiry date whichever is earlier.
• Seal and return unused calibrators to 2-8 °C, under which conditions the stability will be retained for 1 month, for longer use, store opened calibrators in aliquots and freeze at-20 °C. Avoid multiple freeze-thaw cycles.
• Seal and return all the other unused reagents to 2-8 °C, under which conditions the stability will be retained for 2 months, or until the labeled expiry date, whichever is earlier.
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