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DENGUE A Continuing Global Threat Dengue can be Diagnosed & CONFIRMED by: ELISA RANGE: NS1

DENGUE

A Continuing Global Threat

DENGUE A Continuing Global Threat Dengue can be Diagnosed & CONFIRMED by: ELISA RANGE: NS1 ANTIGEN
DENGUE A Continuing Global Threat Dengue can be Diagnosed & CONFIRMED by: ELISA RANGE: NS1 ANTIGEN

Dengue can be

Diagnosed &

CONFIRMED by:

ELISA RANGE:

NS1 ANTIGEN ELISA Test

Dengue NS1 Ag Microlisa

Tests also Available:

RAPID RANGE:

NS1 Antigen and IgM & IgG antibody Rapid Test

Dengue DAY1 Test

NS1 Antigen Rapid Test

Advantage Dengue NS1 Ag Card

POCT TEST:

NS1 Antigen (FINGER PRICK) Test

Dengue NS1 Antigen FP

MAC ELISA Test Dengue IgM Microlisa

GAC ELISA Test Dengue IgG Microlisa

FLUORESCENCE BASED TEST:

Dengue NS1 Antigen (FIA Test)

Dengue NS1 Ag Quanti Card

Dengue Antibody (FIA Test)

Dengue IgM Quanti Card Dengue IgG Quanti Card

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Dengue course of illness & approximate time-line of Primary and Secondary antibodies formation

Figure 2.1 The course of dengue illness * Days of illness 0 1 2 3
Figure 2.1 The course of dengue illness *
Days of illness
0
1 2
3
4 5
6
7
8
9
10
40º
Temperature
Shock
Potential clinical
Reabsorption
Dehydration
bleeding
issues
fluid overload
Organ
impairment
Platelet
Laboratory changes
Hematocrit
IgM /
IgG
VIRAEMIA
Serology and
virology
Course of dengue illness:
Febrile
Critical
Recovery phases
Figure 4.1 Approximate time-line of primary and
secondary dengue
virus infections & the diagnostic
methods that can be used
to detect infection
**
Onset of
-2
0
1
2
3
4
5
6
7
8
9
10
12
symptoms (days)
NS1
Antigen
Detection
VIRAEMIA
IgM Primary
O.D.
IgM Secondary
IgG
Primary
IgG Secondary
O.D.
Onset of symptoms (days)
-2
0
1 2
3
4
5
6
7
8
9
10
12

Dengue is the most rapidly spreading mosquito-borne disease in the world. The key to handle dengue infection is its early

recognition and understanding of the clinical problems during the different phases of the disease, leading to a rational approach to case management and good clinical outcome

(Figure2.1).

Dengue infection is the systematic and dynamic disease. After the incubation period, the illness begins abruptly and is followed by the 3 phases - febrile, critical and recovery (Figure

2.1).

NS1ANTIGEN(Figure4.1)

As can be observed from Figure 4.1, during early stage of disease, Antigen Detection can be used to diagnose the infection.

Detection of NS1 antigen is important for early and accurate diagnosis of dengue. NS1 Antigen can be detected from approximatelyDay1to Day7of feversettingin. IgM ANTIBODIES(Figure4.1) Antibody response to infection differes according to the

immunestatus of thehost.In primaryinfection,IgM antibodies become detectable about 5-6 days after onset of disease. When the viremia declines, IgM level rises quickly to reach peak in about 2weeks.

In Secondary infection IgM antibodies become detectable about4-5days and theirlevels arecomparativelylow.

IgG ANTIBODIES(Figure4.1)

In primary infection, Antibody production of IgG will be at a lower level when compared to IgM. IgG antibodies are generally detectable at low levels in about 11-12 days and increase slowly and remain detectable after several months and probablyeven forlife.

In Secondary infection, the IgG antibody level rises quickly reaching to peak in about 2 weeks after the onset of symptoms and maypersists foryears.

* source: Dengue Guidelines for Diagnosis, Treatment, Prevention & Control, New edition : 2009, WHO, Page No.: 25

source: Dengue Guidelines for Diagnosis, Treatment, Prevention & Control, New edition : 2009, WHO, Page No.: 92

http://whqlibdoc.who.int/publications/2009/9789241547871_eng.pdf

**

s o M y l d a e D A
s
o
M
y
l
d
a
e
D
A

NS1 Ag detection is the method of choice being the direct method and have a balance relationship, between the ease of use or accessibility of a diagnostic method and the confidence in theresults of thetest(Figure4.2).

source: Dengue Guidelines for Diagnosis, Treatment,

Prevention & Control, New edition: 2009, WHO, Page No.: 92

http://whqlibdoc.who.int/publications/2009/9789241547871_eng.pdf

***

For Educational Purpose only.

FIGURE 4.2 COMPARISON OF DIAGNOSTIC TESTS ACCORDING TO THEIR ACCESSIBILITY AND CONFIDENCE *** ACCESSIBILITY DIRECT
FIGURE 4.2 COMPARISON OF DIAGNOSTIC TESTS ACCORDING
TO THEIR ACCESSIBILITY AND CONFIDENCE ***
ACCESSIBILITY
DIRECT METHODS
INDIRECT METHODS
Virus
Genome
NS1
Serology
Serology
isolation
detection
detection
IgM
IgG
CONFIDENCE

ELISA TEST

Dengue NS1 Ag Microlisa

Microwell ELISA Test for the Detection of Dengue NS1 Antigen in Human Serum/ Plasma

TEST PRINCIPLE

TEST PROCEDURE

Microwells pre-coated with Anti-Dengue NS1 Antibodies

Binding of Dengue NS1 antigen with Anti-Dengue NS1 antibody Addition of Anti-Dengue NS1 antibody linked
Binding of Dengue NS1 antigen with Anti-Dengue NS1 antibody

Binding of Dengue NS1 antigen with Anti-Dengue NS1 antibody

Addition of Anti-Dengue NS1 antibody linked to HRPO (Enzyme Conjugate)

Addition of Anti-Dengue NS1 antibody linked to HRPO (Enzyme Conjugate)

Addition of Chromogenic Substrate

Addition of Chromogenic Substrate

Addition of Stop Solution and final reading of results at 450 nm / 630 nm

Addition of Stop Solution and final reading of results at 450 nm / 630 nm

Add 50 µl diluent in each well. Add 50 µl NC in A1 well, 50µl calibrator in B1, C1 & D1well, add 50 µl PC in E1 well, and add 50 µl sample to F1 well onwards

Prepare working conjugate solution

Add 100 µl working conjugate in each well

Cover the plate and incubate for 90 min. at 37ºC

Wash 6 cycles

Prepare working substrate solution

Add 150 µl working substrate in each well

Incubate in dark for 30 min at room temperature. (20ºC - 30ºC)

Add 100µl Stop Solution and read result at 450 nm/630 nm.

B1
B1

A1

C1

D1

E1

F1

G1

H1

 
 
 
 
 
 
 

NC

CAL

CAL

CAL

PC

S1

S2

S3

No. of strip

1

2

3

4

5

6

7

8

9

10

11

12

Enzyme

20

40

60

80

100

120

140

160

180

200

220

240

Conjugate(µl)

Diluent (ml)

1

2

3

4

5

6

7

8

9

10

11

12

1 2 3 4 5 6 7 8 9 10 11 12 No. of strip 1
1 2 3 4 5 6 7 8 9 10 11 12 No. of strip 1
1 2 3 4 5 6 7 8 9 10 11 12 No. of strip 1

No. of strip

1

2

3

4

5

6

7

8

9

10

11

12

TMB

0.8

1.6

2.4

3.2

4.0

4.8

5.6

6.4

7.2

8.0

8.8

9.6

Substrate (ml)

TMB

0.8

1.6

2.4

3.2

4.0

4.8

5.6

6.4

7.2

8.0

8.8

9.6

Diluent (ml)

(ml) TMB 0.8 1.6 2.4 3.2 4.0 4.8 5.6 6.4 7.2 8.0 8.8 9.6 Diluent (ml)
(ml) TMB 0.8 1.6 2.4 3.2 4.0 4.8 5.6 6.4 7.2 8.0 8.8 9.6 Diluent (ml)
(ml) TMB 0.8 1.6 2.4 3.2 4.0 4.8 5.6 6.4 7.2 8.0 8.8 9.6 Diluent (ml)
5.6 6.4 7.2 8.0 8.8 9.6 Diluent (ml) anti-dengue NS1 antibody NS1 antigen in the sample

anti-dengue NS1 antibody

anti-dengue NS1 antibody NS1 antigen in the sample

NS1 antigen in the sample

HRPO labelled anti-dengue Ns1 antibody

Chromogenic Substrate TMB

Stop Solution

Stop Solution

Direct test method for Detecting infection with Dengue NS1 AgNs1 antibody Chromogenic Substrate TMB Stop Solution Excellent sensitivity against all the 4 serotypes of Dengue

Excellent sensitivity against all the 4 serotypes of Dengue Virus Antigentest method for Detecting infection with Dengue NS1 Ag Significant reduction of Window period Based on

Significant reduction of Window periodagainst all the 4 serotypes of Dengue Virus Antigen Based on Direct Sandwich ELISA No sample

Based on Direct Sandwich ELISADengue Virus Antigen Significant reduction of Window period No sample dilution is required Long Shelf Life:

No sample dilution is requiredreduction of Window period Based on Direct Sandwich ELISA Long Shelf Life: 18 months at 2-8

Long Shelf Life: 18 months at 2-8º C ºC

Color Coded reagentdilution is required Long Shelf Life: 18 months at 2-8 º C Convenient Packsize: 48 Tests

Convenient Packsize: 48 Tests & 96 TestsLong Shelf Life: 18 months at 2-8 º C Color Coded reagent PATENT NO.: 262334 Sensitivity:

PATENT NO.: 262334
PATENT NO.: 262334

Sensitivity: 99.5% Specificity: 100%

Dengue IgM Microlisa

ELISA TEST

Dengue IgG Microlisa

MAC ELISA (Capture Principle) Test for the Detection of Dengue IgM Antibodies in Human Serum/ Plasma

TEST PROCEDURE

GAC ELISA (Capture Principle) Test for the Detection of Dengue IgG Antibodies in Human Serum/ Plasma

TEST PRINCIPLE

Dilute sample (1:100) sample 10 µl + sample diluent 1000µl Add 100 µl control, calibrator
Dilute sample (1:100)
sample 10 µl + sample diluent 1000µl
Add 100 µl control, calibrator & diluted sample
in respective wells.
A1
B1
C1
D1
E1
F1
G1
H1
Microwells pre-coated
with Anti-Human IgM/ IgG
Antibodies
NC
Cal
Cal
Cal
PC
S1
S2
S3
Cover the plate and incubate for 60 min. at 37ºC
IgM/ IgG Antibodies bind
with Anti-human IgM/ IgG
Antibodies respectively
Wash (5 cycles)
No. of strip
1
2
3
4
5
6
7
8
9
10
11
12
Prepare working conjugate solution (1:10)
Enzume conjugate 0.1
Concentrate (ml).
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
1.1
1.2
Conjugate
0.9
1.8
2.7
3.6
4.5
5.4
6.3
7.2
8.1
9.0
9.9
10.8
Diluent(ml).
Add 100 µl working conjugate in each well
Binding of Dengue
Antigen conjugated
with HRPO (Enzyme
Conugate)
Cover the plate and incubate for 60 min. at 37ºC
Wash (5 cycles)
Addition of Substrate
No. of strip
TMB
Substrate (ml).
TMB
Diluent( ml).
1
2
3
4
5
6
7
8
9
10
11
12
Prepare working substrate solution
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
5.0
5.5
6.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
5.0
5.5
6.0
Add 100 µl working substrate in each well
Addition of Stop Solution
and final reading of results
at 450 nm / 630 nm
Incubate in dark for 30 min at room temperature.
Anti-Human IgM/IgG
Add 50 µl Stop Solution and read result at
450 nm/630 nm.
antibody
IgM antibody
in the sample
IgG antibody in the sample
Dengue Antigen
conjugated with HRPO
* The Preparation of working conjugate and substrate solution mentioned above in the respective table is
suggestive only, however both working conjugate and substrate solution can be prepared in any amount
proportionately as per requirement of tests to be performed (from 5 tests to 96 tests as 3 calibrator,
1 negative control and 1 positive control are to be included in each run).
Substrate TMB
Stop Solution
Principle : "Advance Capture" ELISA
Enzyme conjugate concentrate, liquid stable for
18 months, easy to use, no wastage
PATENT NO.: 224468
Excellent Sensitivity against all
4 serotypes of Dengue
High signal to noise ratio
Color Coded reagents to monitor
procedural steps
Long shelf Life: 18 months at 2-8ºC
Sensitivity: 99.13%
Specificity: 99.84%
Unique Break-away wells
Sensitivity: 98.66%
Specificity: 99.93%
PATENT NO.: 224471
Convenient Packsize: 48 Tests & 96 Tests

RAPID TEST

NO.: 262648* PATENT PATENT NO.: 235938** &
NO.: 262648*
PATENT
PATENT NO.:
235938** &

DENGUE DAY 1 TEST

Rapid visual test for the detection of Dengue NS1 Antigen and differential detection of IgM & IgG antibodies in Human Serum/ Plasma

First-Line Testing Kit for Dengue diagnosisdetection of IgM & IgG antibodies in Human Serum/ Plasma Rapid visual test for Dengue NS1

Rapid visual test for Dengue NS1 Antigen and IgM & IgG Antibodies detectionSerum/ Plasma First-Line Testing Kit for Dengue diagnosis Diagnosis of both Primary & Secondary Infection Detects

Diagnosis of both Primary & Secondary InfectionDengue NS1 Antigen and IgM & IgG Antibodies detection Detects all 4 serotypes of Dengue Virus

Detects all 4 serotypes of Dengue VirusDiagnosis of both Primary & Secondary Infection Highly Sensitive & Highly Specific Long Shelf Life 24

Highly Sensitive & Highly SpecificSecondary Infection Detects all 4 serotypes of Dengue Virus Long Shelf Life 24 months at 2-30

Long Shelf Life 24 months at 2-30º C ºC

Convenient Packsize: 10 Tests, 30 Tests & 50 Tests& Highly Specific Long Shelf Life 24 months at 2-30 º C Dengue NS1 Ag: Sensitivity:

Dengue NS1 Ag:
Dengue NS1 Ag:

Sensitivity: 96%

Dengue IgM/IgG antibody:

Specificity: 97%

*Patented Device for Dengue NS1 Ag **Patented Device for Dengue IgM & IgG Antibody Card

Specificity: 98%

Sensitivity: 95%

Why Dengue DAY1 Test , Antigen & Antibody (Combi test) is more Reliable in Dengue

Why Dengue DAY1 Test, Antigen & Antibody (Combi test) is more Reliable in Dengue Diagnosis

Antibody (Combi test) is more Reliable in Dengue Diagnosis Study highlights that using dengue NS1 antigen

Study highlights that using dengue NS1 antigen detection in combination with IgM and IgG serology can significantly increase the sensitivity of acute dengue diagnosis and extends the possible window of detection to include very early acute samples and enhances the clinical utility of rapid immunochromatographictestingfordengue.

Source : RESEARCH ARTICLE: The Diagnostic Sensitivity of Dengue Rapid Test Assays Is Significantly Enhanced by Using a Combined Antigen and Antibody Testing Approach

www.plosntds.org/article/info%3Adoi%2F10.1371%2Fjournal.pntd.0001199

POCT (Point of Care) TEST

Ideal test for Physician's Clinic & Nursing Homes for immediate results.
Ideal test for
Physician's Clinic
&
Nursing Homes
for immediate
results.

DENGUE NS1 ANTIGEN FP

Finger Prick quick visual test for the detection of Dengue NS1 Antigen in Human Whole Blood/ Serum/ Plasma

Point of Care Test (POCT)of Dengue NS1 Antigen in Human Whole Blood/ Serum/ Plasma Finger Prick quick visual test for

Finger Prick quick visual test for detection of Dengue NS1 AntigenHuman Whole Blood/ Serum/ Plasma Point of Care Test (POCT) Results within 20 minutes From DAY1

Results within 20 minutesPrick quick visual test for detection of Dengue NS1 Antigen From DAY1 of the fever, It

From DAY1 of the fever, It detects all 4 serotypes of Dengue Virusdetection of Dengue NS1 Antigen Results within 20 minutes Highly Sensitive & Highly Specific Individually pouched

Highly Sensitive & Highly Specificof the fever, It detects all 4 serotypes of Dengue Virus Individually pouched test device Longer

Individually pouched test deviceof Dengue Virus Highly Sensitive & Highly Specific Longer Shelf Life: 24 Months At 2-30 º

Longer Shelf Life: 24 Months At 2-30º C ºC

Patented Product: Patent No.: 262648 262648

Prompt Service Backuptest device Longer Shelf Life: 24 Months At 2-30 º C Patented Product: Patent No.: 262648

Convenient Packsize: 10 Testspouched test device Longer Shelf Life: 24 Months At 2-30 º C Patented Product: Patent No.:

Specifications/ Designs are subjected to change without any obligation on the part of the Manufacturer

R-09

BR/DER/006

FLUORESCENCE IMMUNOASSAY

Quant Analyzer

Fluorescence Immunoassay (FIA)

Developed in partnership with HTIC, IIT Madras, India PATENT NO.: 262648 DENGUE NS1 Ag Quanti
Developed in partnership
with HTIC,
IIT Madras, India
PATENT NO.: 262648
DENGUE NS1 Ag
Quanti Card
Fluorescence immunoassay for qualitative
detection of Dengue NS1 Antigen
in Human Serum/ Plasma
DENGUE IgG
Quanti Card

Principle: Based on most advanced fluorescence immunoassay methodNS1 Antigen in Human Serum/ Plasma DENGUE IgG Quanti Card Individually pouched test cartridge, each cartridge

Individually pouched test cartridge, each cartridge is precision engineered with embeded lot data.Based on most advanced fluorescence immunoassay method Results within 30 Minutes Sensitivity: 100%* &

Results within 30 Minutescartridge is precision engineered with embeded lot data. Sensitivity: 100%* & Specificity: 98.38%* (In

Sensitivity: 100%* & Specificity: 98.38%* (In comparison with ELISA Test) 100%* & Specificity: 98.38%* (In comparison with ELISA Test)

Long Shelf Life: 18 Months at 2-8ºC& Specificity: 98.38%* (In comparison with ELISA Test) Available Packsize: 24 & 48 Tests * Source:

Available Packsize: 24 & 48 Testswith ELISA Test) Long Shelf Life: 18 Months at 2-8ºC * Source: https://doi.org/10.20546/ijcmas.2017.611.061,

* Source: https://doi.org/10.20546/ijcmas.2017.611.061,

Table-3, Page- 510

DENGUE IgM Quanti Card

Fluorescence immunoassay for the qualitative measurement of Dengue IgM Antibodies in Human Serum/ Plasma

Principle: Based on most advanced fluorescence immunoassay methodmeasurement of Dengue IgM Antibodies in Human Serum/ Plasma Individually pouched test cartridge, each cartridge is

Individually pouched test cartridge, each cartridge is precision engineered with embeded lot data.Based on most advanced fluorescence immunoassay method Results within 40 Minutes Sensitivity: 96.72% &

Results within 40 Minutescartridge is precision engineered with embeded lot data. Sensitivity: 96.72% & Specificity: 97.45% (In

Sensitivity: 96.72% & Specificity: 97.45% (In comparison with ELISA Test: 96.72% & Specificity: 97.45% (In comparison with ELISA Test:

Dengue IgM Microlisa)

Fluorescence immunoassay for the qualitative measurement of Dengue IgG Antibodies in Human Serum/ Plasma

Principle: Based on most advanced fluorescence immunoassay methodmeasurement of Dengue IgG Antibodies in Human Serum/ Plasma Individually pouched test cartridge, each cartridge is

Individually pouched test cartridge, each cartridge is precision engineered with embeded lot data.Based on most advanced fluorescence immunoassay method Results within 40 Minutes Sensitivity: 97.23% &

Results within 40 Minutescartridge is precision engineered with embeded lot data. Sensitivity: 97.23% & Specificity: 97.36% (In

Sensitivity: 97.23% & Specificity: 97.36% (In comparison with ELISA Test: 97.23% & Specificity: 97.36% (In comparison with ELISA Test:

Dengue IgG Microlisa)

Long Shelf Life: 18 Months at 2-8ºC97.36% (In comparison with ELISA Test: Dengue IgG Microlisa) Available Packsize: 24 & 48 Tests Long

Available Packsize: 24 & 48 TestsDengue IgG Microlisa) Long Shelf Life: 18 Months at 2-8ºC Long Shelf Life: 18 Months at

Long Shelf Life: 18 Months at 2-8ºC18 Months at 2-8ºC Available Packsize: 24 & 48 Tests Available Packsize: 24 & 48 Tests

Available Packsize: 24 & 48 Tests24 & 48 Tests Long Shelf Life: 18 Months at 2-8ºC Also Connect with us on:

Also Connect with us on:

Packsize: 24 & 48 Tests Also Connect with us on: ISO 9001:2015 & ISO 13485:2016 For
Packsize: 24 & 48 Tests Also Connect with us on: ISO 9001:2015 & ISO 13485:2016 For
Packsize: 24 & 48 Tests Also Connect with us on: ISO 9001:2015 & ISO 13485:2016 For
Packsize: 24 & 48 Tests Also Connect with us on: ISO 9001:2015 & ISO 13485:2016 For
Packsize: 24 & 48 Tests Also Connect with us on: ISO 9001:2015 & ISO 13485:2016 For
ISO 9001:2015 & ISO 13485:2016
ISO 9001:2015 &
ISO 13485:2016

For further enquiries, Please contact:

J. Mitra & Co. Pvt. Ltd.

A 180-181, Okhla Indl. Area, Phase-1, New Delhi - 110 020, INDIA Tel: +91-11-47130300, 500, 26818971-73

E-mail: jmitra@jmitra.co.in

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