OnSite Rubella IgG/IgM Rapid

Test

Novel

Unique

& Only

Semi-Quantitative 4-Line Rapid Test

About Rubella

• A disease caused by the rubella virus

• Is transmitted by air (coughing and sneezing)

• Vaccination is available to protect from infection,

but not administered in all countries

• An infection during the 3-4th month of pregnancy is associated with fetal infections and birth defect (congenital rubella)

• SHOULD be tested for proper action and for a healthy baby

Who Should Get Tested for Rubella?

• Critical diagnosis should address:

1) Does the patient have protective immunity?

2) Is the patient at risk of infection?

3) Does the patient have an acute infection that could lead to high risk of congenital rubella for the child?

• Women of childbearing age

• Pregnant woman at first post-conceptual appointment, or at first-trimester

How Is Rubella Diagnosed?

• Clinical symptoms are unreliable to diagnosis Rubella.- Rash symptom is not specific for rubella

- Up to 50% of rubella infection is asymptomatic

• Laboratory test is essential for diagnosis of Rubella.1) Serological test is the primary diagnostic method:

levels of IgG indicate if protective immunity is present; IgM and increase in IgG titer to indicate potential acute infection

2) Virus culture / PCR to confirm an acute infection.

≥250

IgM positive

Science for Serological Test At Risk Acute Infection Protected/past infection

infection

IgG<15 IU/mL IgG≥15 IU/mLIgG (IU/mL)<15

≥15

IgM negative IgM negative

Antib

ody

tite

r

weeks months

Time

IgG15 IU/mL

IgG250 IU/mLIgG

IgM

• Simple but accurate screening test to be used at any place – No woman is at risk – No new born baby is at risk

• A test can detect both IgG and IgM

• A test with IgG quantitative information

The Market Need

OnSite Rubella IgG/IgM Rapid TestNOVEL & UNIQUELY DESIGNED, SEMI-QUANTITATIVE 4-LINE TEST

• The ONLY test on the market to predict if a patient is:

at risk of an infection, or currently infected, or protected from infection

• Detects IgM and IgG simultaneously

• Differentiates 15 IU/mL and 250 IU/mL of IgG

• Be used with serum, plasma and whole blood

10 minutes

OnSite Rubella IgG/IgM Rapid Test Procedure

Quick and simple all-in-one test

10µL of serum or plasma

10µL of whole blood

2 drop of sample diluent

Result

Specimen line

Specimen line

Result Interpretation

At Risk

IgG<15 IU/mL

IgM negative

IgGIgM

Time

IgG15 IU/mL

IgG250 IU/mL

Antib

ody

tite

r

weeks months

Result Interpretation An

tibod

y ti

ter

weeks months

Time

IgG15 IU/mL

IgG250 IU/mL

IgG ≥15 IU/mL IgG ≥250 IU/mLIgG<15 IU/mL

IgG (IU/mL)<15

≥15≥250

Acute Infection

IgM positive

infection

IgGIgM

Result Interpretation

IgG≥15 IU/mL

IgM negative

Protected/past infection

Antib

ody

tite

r

weeks months

Time

IgG15 IU/mL

IgG250 IU/mLIgG

IgM

• The G1 and G2 test lines of the OnSite Rubella IgG/IgM Rapid Test have been calibrated towards the WHO reference standard RUBI-1-94.

OnSite Rubella IgG/IgM RDT Limit of Detection of the G1 and G2 Test Lines

0 5 10 15 20 30 60

Number Positive 0 2 13 19 20 20 20Number Negative 20 18 7 1 0 0 0Total repeats 20 20 20 20 20 20 20

Limit of detection: G1 test line: 15 IU/mL

Limit of detection: G2 test line: 250 IU/mL30 60 100 160 200 250 300

Number Positive 0 4 11 13 18 20 20Number Negative 20 16 9 7 2 0 0Total repeats 20 20 20 20 20 20 20

OnSite IgG/IgM Rubella Rapid TestG1 Test Line Detection

ReferenceELISA Positive Negative Total

Positive 171 3 174

Negative 2 38 40

Total 173 41 214

• Performance of G1 test line on random clinical specimens

OnSite Rubella IgG/IgM RDT Comparable to the Market Leading ELISA

Relative sensitivity: 98.2%, relative specificity: 90.5%, overall agreement: 96.7%

• Performance of G2 test line on random clinical specimens:100% agreement with reference ELISA

• The OnSite Rubella IgG/IgM Rapid Test was evaluated with 10,000 random clinical specimens.

OnSite Rubella IgG/IgM RDT Positive Rate Matches Literatures

M Line G1 Line G2 Line

Positive rate 0.3% 87% 7%

• The reported positive rates

IgG positive rate (≥10-15IU/mL): 80-94% IgG positive rate (200-250IU/mL): 3.4% IgM positive rate: 0.3-1.7%

• Has good agreement with the reference ELISA tests• Has superior IgM specificity to a competitor Rapid Test

OnSite Rubella IgG/IgM RDT Correctly Detects BBI Rubella Performance Panel

BBI Panel Test(by Abbott ELISA )

Number of Specimens

OnSite Rubella IgG/IgM Rapid Test Competitor RDT

M Positive

G1 Positive

G2 Positive

IgMPositive

IgM Negative 20 0 0 0 4IgM Positive 5 4 0 0 4

IgG < 15 IU/mL 2 0 0 0 N/A

15 ≤ IgG <250 IU/mL 14 0 14 0 N/A

IgG ≥ 250 IU/mL 9 0 9 6 N/A

• The OnSite Rubella IgG/IgM Rapid Test has no false positive on specimens from patients with other disease states

OnSite Rubella IgG/IgM RDT Low Cross-Reactivity

OnSite Rubella IgG/IgM Rapid Test Disease states Specimens tested Result (M, G1, G2) CMV 5 Negative Dengue 6 Negative HAV 10 Negative HBV 10 Negative HCV 10 Negative HIV 5 Negative H. pylori 10 Negative HSV-1 5 Negative HSV-2 5 Negative Syphilis 9 Negative TB 6 Negative Toxoplasma 3 Negative ANA 6 Negative HAMA 4 Negative RF (up to 2,500IU/mL) 14 Negative

• The OnSite Rubella IgG/IgM Rapid Test has no interference from common medicines and blood components.

OnSite Rubella IgG/IgM RDT

Low Risk of Interference

Substances tested Concentrations tested

Albumin 60 g/LBilirubin 20 mg/dLCreatinine 442 μmol/LEDTA 3.4 µmol/LGlucose 55 mmol/LHemoglobin 2 g/LHeparin 3,000 U/LSalicylic Acid 4.34mmol/L

Sodium citrate 3.8%

OnSite Rubella IgG/IgM Rapid TestA Novel, Unique Rubella Test on the Market

Method OnSite Rapid Test ELISA Chemiluminesence

Detect IgM and IgG in 1 device(2 levels of IgG)

IgG and IgM separately

IgG and IgM separately

Procedure 2 steps Multiple Multiple

Time to result 10 minutes 2-3 hours 2-3 hours

Equipment No Moderate Expensive

Complexity Minimal Moderate Moderate

Storage 2-30 ℃ 4 ℃ 4 ℃

Cost Low Moderate High

Suitable for screening Yes Yes/No No

OnSite Rubella IgG/IgM Rapid TestNOVEL & UNIQUELY DESIGNED, SEMI-QUANTITATIVE 4-LINE TEST

• The ONLY test on the market to predict if a patient is:

at risk of an infection, or currently infected, or protected from infection

• Detects IgM and IgG simultaneously

• Differentiates 15 IU/mL and 250 IU/mL of IgG

• Be used with serum, plasma and whole blood specimens

• Is validated on BBI rubella performance panel

• IgG results are calibrated against WHO reference standard RUBI-1-94

• Highly sensitive and specific

OnSite Rubella IgG/IgM Rapid TestNovelty and Uniqueness

Proper selection of the detection levels of IgG test lines:

G1 line LOD at 15 IU/ml, not 10 IU/ml to make positive result at high correlation with the protective immunity

G2 line LOD at 250 IU/mL for accurate diagnosis of active infection

Antib

ody

tite

r

IgG

IgM

weeks monthsTime

IgG15 IU/mL

IgG250 IU/mL

Contact Info.:10110 Mesa Rim Rd. San Diego, CA 92121 USAEmail Address: tech@ctkbiotech.com Telephone: 1 (858) 457-8698Fax: 1 (858) 535-1739

Technical Support

THANK YOU

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