Dengue IgG/IgM/NS1 Combo Rapid Test Device/medical/laboratory/healthcare diagnostic,Zhuhai Encode Medical Engineering Co.,Ltd_specification/price/image

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INTENDED USE

The Dengue IgG/IgM/NS1 Combo Rapid Test Device is a lateral flow chromatographic immunoassay for the qualitative detection of dengue IgG/ IgM and virus antigen (Dengue Ag) 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 Dengue viruses. Any reactive specimen with the Dengue IgG/IgM/NS1 Combo Rapid Test Device must be confirmed with alternative testing method(s) and clinical findings.

REAGENTS AND MATERIALS PROVIDED

1.Each foil pouch contains with three items inside:

a. One cassette device with Dengue IgG/IgM and Ag NS1 test strips.

b. One plastic dropper.

c. One desiccant.

2.Sample Diluent

3.One package insert (instruction for use).

ASSAY PROCEDURE

Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.

Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.

Step 3: Be sure to label the device with specimen’s ID number.

Step 4: For whole blood samples:

Fill the dropper with the specimen then add 10µL of specimen and 2 drops of buffer into the IgG/ IgM sample well and 2 drops of specimen and 1 drops of buffer into NS1 sample well, making sure that there are no air bubbles.

For Plasma/ Serum samples:

Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense 5 µL of specimen and 2 drops of buffer into the IgG/ IgM sample well and 2 drop of specimen and 1 drops of buffer into the NS1 sample well, making sure that there are no air bubbles.

Step 5:Set up a timer.

Step 6: Results can be read in 15 minutes. Positive results can be visible in as short as 1 minute.

Don’t read results after 30 minutes. To avoid confusion, discard the test device after interpreting the result.

INTERPRETATION OF RESULTS

Dengue IgG/ IgM Rapid Test:

POSITIVE RESULT:	IgG Positive:The colored line in the control line region (C) appears and a colored line appears in test line region 1 (G). The result is positive for Dengue virus specificIgG and is probably indicative of secondary Dengue infection.

POSITIVE RESULT:

IgG Positive:The colored line in the control line region (C) appears and a colored line appears in test line region 1 (G). The result is positive for Dengue virus specificIgG and is probably indicative of secondary Dengue infection.

	IgM Positive:* The colored line in the control line region (C) appears and a colored line appears in test line region 2 (M). The result is positive for Dengue virus specific-IgM antibodies and is indicative of primary Dengue infection.
	IgG and IgM Positive:* The colored line in the control line region (C) appears and two colored lines should appear in test line regions 1 and 2 (G and M). The color intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies and is indicative of secondary Dengue infection.
*NOTE: The intensity of the color in the test line region(s) (G and/or M) will vary depending on the concentration of Dengue antibodies in the specimen. Therefore, any shade of color in the test line region(s) (G and/or M) should be considered positive.
NEGATIVE RESULT:	The colored line in the control line region (C) appears. No line appears in test line regions 1 or 2 (G or M).
INVALID RESULT:	Control band fails to appear. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Dengue NS1 Rapid Test:

POSITIVE RESULT:	Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (NS1).
NEGATIVE RESULT:	Only one colored band appears in the control region (C). No apparent colored band appears in the test region (NS1).
INVALID RESULT:	Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

POSITIVE RESULT:

Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (NS1).

NEGATIVE RESULT:

Only one colored band appears in the control region (C). No apparent colored band appears in the test region (NS1).

INVALID RESULT:

Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

PERFORMANCE CHARACTERISTICS

Clinical Performance

Dengue IgG/IgM Rapid Test:

The specimens obtained from a population of symptomatic and asymptomatic individuals. Results were confirmed by a leading commercial Dengue ELISA test.

Dengue IgG/IgM Rapid Test vs. ELISA

Dengue Infection	Result	Ig M	IgG
Primary Infection	Positive	14	0
	Negative	3	17
	Total	17	17
	Relative Sensitivity	82.4%	0%
Secondary Infection	Positive	39	55
	Negative	16	0
	Total	55	55
	Relative Sensitivity	70.9%	>99.0%
Non-Dengue Infection	Positive	0	0
	Negative	378	378
	Total	378	378
	Relative Specificity	>99.0%	>99.0%

For the primary and secondary infection, the overall sensitivity is 95.8%, the overall specificity is >99.0% and the overall accuracy is 99.3%.

Dengue NS1 Rapid Test:

A total of 114 patient samples from susceptible subjects were tested by the Dengue NS1 Rapid Test Strip and by a commercial EIA. Comparison for all subjects is showed in the following table:

	Dengue NS1 Rapid Test
Dengue Ag EIA Test	Positive	Negative	Total
Positive	66	3	69
Negative	2	43	45
Total	68	46	114

Relative Sensitivity: 95.6%, Relative Specificity: 95.5%, Overall Agreement: 95.6%