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 3-4 th 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/mL IgG (IU/mL) <15 ≥15 IgM negative Antibody titer weeks months Time IgG15 IU/mL IgG250 IU/mL IgG 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 Test NOVEL & UNIQUELY DESIGNED, SEMI-QUANTITATIVE 4-LINE TEST ONLY 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

Result Interpretation At Risk IgG <15 IU/mL IgM negative IgG IgM Time IgG15 IU/mL IgG250 IU/mL Antibody titer weeks months

Result Interpretation Antibody titer weeks months Time IgG15 IU/mL IgG250 IU/mL IgG ≥15 IU/mL IgG ≥250 IU/mL IgG<15 IU/mL IgG (IU/mL) <15 ≥15 ≥250 Acute Infection IgM positive infection IgG IgM

Result Interpretation IgG ≥15 IU/mL IgM negative Protected/past infection Antibody titer weeks months Time IgG15 IU/mL IgG250 IU/mL IgG IgM

The G1 and G2 test lines of the OnSite Rubella IgG/IgM Rapid Test have been calibrated towards the WHO reference standard RUBI OnSite Rubella IgG/IgM RDT Limit of Detection of the G1 and G2 Test Lines Number Positive Number Negative Total repeats20 Limit of detection: G1 test line: 15 IU/mL Limit of detection: G2 test line: 250 IU/mL Number Positive Number Negative Total repeats20

OnSite IgG/IgM Rubella Rapid Test G1 Test Line Detection Reference ELISA PositiveNegativeTotal Positive Negative23840 Total 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 LineG1 LineG2 Line Positive rate0.3%87%7% The reported positive rates  IgG positive rate (≥10-15IU/mL): 80-94%  IgG positive rate ( IU/mL): 3.4%  IgM positive rate: %

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 TestCompetitor RDT M Positive G1 Positive G2 Positive IgM Positive IgM Negative IgM Positive IgG < 15 IU/mL 2000N/A 15 ≤ IgG <250 IU/mL 140 0N/A IgG ≥ 250 IU/mL 9096N/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 statesSpecimens testedResult (M, G1, G2) CMV5Negative Dengue 6 Negative HAV10Negative HBV10Negative HCV10Negative HIV5Negative H. pylori10Negative HSV-15Negative HSV-25Negative Syphilis9Negative TB 6Negative Toxoplasma3Negative ANA6Negative HAMA 4Negative RF (up to 2,500IU/mL)14Negative

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 testedConcentrations tested Albumin60 g/L Bilirubin20 mg/dL Creatinine442 μmol/L EDTA3.4 µmol/L Glucose55 mmol/L Hemoglobin2 g/L Heparin3,000 U/L Salicylic Acid4.34mmol/L Sodium citrate3.8%

OnSite Rubella IgG/IgM Rapid Test A Novel, Unique Rubella Test on the Market MethodOnSite Rapid TestELISAChemiluminesence Detect IgM and IgG in 1 device (2 levels of IgG) IgG and IgM separately Procedure2 stepsMultiple Time to result10 minutes2-3 hours EquipmentNoModerateExpensive ComplexityMinimalModerate Storage 2-30 ℃ 4℃4℃ 4℃4℃ CostLowModerateHigh Suitable for screening YesYes/NoNo

OnSite Rubella IgG/IgM Rapid Test NOVEL & UNIQUELY DESIGNED, SEMI-QUANTITATIVE 4-LINE TEST ONLY 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 Test Novelty 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 Antibody titer IgG IgM weeks months Time IgG15 IU/mL IgG250 IU/mL

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