Aria RAPID TESTREGISTEREDFACILITY

Typhoid Rapid TestReliable & Simple Resource for Screening Salmonella Fever

Current methods for diagnosing salmonella (typhi and paratyphi) infection are predominantly blood culture, Widal test, and other immunoassays. Rapid Tests have become more popular recently.

SALMONELLA FEVER DIAGNOSIS

1 2 3 4 5 6 7 8

Blood cultureIgM

IgG

Weeks

Disease

Blood culture tests, performed in laboratories, take about 3 to 4 days to develop results, and are therefore impractical for early diagnosis. In addition, the culture sensitivity is often compromised in regions with overuse of antibiotics

The Widal test has multiple procedural steps, with difficult result interpretation and often leads to misdiagnosis followed with misuse of antibiotics

Rapid Test, simple procedure and fast results, detects IgG and IgM responding to infection

FEATURES OF TYPHOID RAPID TEST BY CTK

Negative Positive

CGM

CGM

CGM

CGM

15minutes

Typhoid IgG/IgM Rapid Test

TyphoidIgG/IgM

ID

B

CG

M

S

TyphoidIgG/IgM

ID

B

CG

M

S

R0160C S/P

Typhoid IgG/IgM Combo Rapid Test

Typhoid

IgG/IgM Combo

ID

B

CG

M

S

Typhoid

IgG/IgM Combo

ID

B

CG

M

S

R0161C S/P/WB

Detects IgG and IgM to S. Typhi and paratyphi in the same testUses highly purified somatic O and flagellar H antigens to increase sensitivity

Requires minimal training and no equipmentDesigned for all settings including field or remote locations, doctor's office, small and large laboratories

Results are obtained in 15 minutes allowing immediate action to be taken (compared with 3-4 days by blood culture)Simple test procedure and easy to interpret result minimize operator errors associated with Widal testResults are not affected by antibiotic treatment as seen in culture method

RELIABLE

PRACTICAL

SUPERIOR

ARIA-MK-FLR-R0160 Rev 3.0

CTK Biotech, Inc.

10110 Mesa Rim RoadSan DIego, CA 92121, USAwww.ctkbiotech.com

T +1 858 457 8698F +1 858 535 1739E info@ctkbiotech.com

Aria Typhoid Rapid TestReliable & Simple Resource for Screening Salmonella Fever

Country China Indonesia Madagascar Pakistan

Specimens 11 Typhi, 9 Paratyphi A 60 Typhi-Paratyphi 20 Suspicious specimens 20 Suspicious specimens

Reference Test

Test Blood culture Widal test Widal test Tubex IgM test

Result 100% Positive 69% Positive (H) 20% Positive (H) 100% Positive

Typhoid IgG/IgM Rapid Test

95% Positive 88% IgG Positive 30% IgG Positive 100% Positive via extended protocol

Aria

Aria Typhoid IgG/IgM Rapid Test Performance (3rd party evaluations)

Result

Test Parameter Blood Culture Widal Test Tubex IgM Test Aria Typhoid IgG/IgM Rapid Test

Principle Live bacterial replication Agglutination immunoassay Competitive immunoassay Lateral flow immunoassay

Antigen used N/A S. Typhi & S.Paratyphi O and H antigens S. Typhi O antigen S. Typhi & S.Paratyphi O and H antigens

Test procedure

1. Culture blood in broth fro m pro -enrichment

2. Dual selection enrichment 3. Dual plating. Total 3-4 day procedure

1. Pre-dilute specimen to a series of 8dilution s

2. Add O, H, AH, BH Widal Test reagents to all of the 8 tubes

3. Incubate at 37°C over night

1. Add Reagent A to test tube 2. Add specimen to the tube 3. Add Reagent B to the tube 4. Shake for 2 minutes 5. Separation by magnet

1. Add specimen to the test device 2. Add Sample Diluent to the test

device Read result in 15 mins

Result reading Traditional or biochemical identification Visually observ e sediments Visually observe color change Visually observe colored IgG or IgM band

Requirement • Incubator • Electricity • Trained personnel

• Dedicated lab staff • Tubes, water bath or incubator

• Shaker • Magnet • Minimal training

• No equipment required • Minimal training

Comments

•

Gold Standard

method

•

Not a screening test

•

Time consuming

•

Prone to

operator error

•

Losing its relevance in western and European nations

•

Cross reactive

•

Fast but expensive

•

Does not detect

S. Paratyphi

•

Does not detect IgG antibodies at latent or chronic status

• Fast & inexpensive • Can be used and stored in a

wide range of temperature• Detects both S. Typhi &

Paratyphi infection• Detects latent or chronic infection

•

High reproducibility

The most over-utilized test

•

3.

• Lab technician preferred

Result Comparison between Widal Test and Aria Rapid Test

Comparison of Salmonella Fever Diagnostic Tests on the Market

ResultWidal test Typhi O antigenWidal test Typhi O antigenWidal test Paratyphi H antigenWidal test Paratyphi H antigen

Aria IgM NegativeAria IgM PositiveAria IgG PositiveAria IgG Positive

1: 401: 801: 801: 160

Study in Madagascar, 2011