Transcript 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.

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?
• Women of childbearing age
• Pregnant woman at first post-conceptual appointment,
or at first-trimester
• 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?
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.
Science for Serological Test
Acute Infection
At Risk
IgM positive
IgMnegative
Antibody titer
Protected/past infection
IgM negative
IgG250 IU/mL
IgG
infection
IgM
IgG15 IU/mL
Time
weeks
≥15
months
≥250
<15
IgG<15 IU/mL
IgG (IU/mL)
IgG≥15 IU/mL
The Market Need
•
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
OnSite Rubella IgG/IgM Rapid Test
NOVEL & 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
OnSite Rubella IgG/IgM Rapid Test
Procedure
Quick and simple all-in-one test
Specimen line
10µL of serum or plasma
Result
2 drop of sample diluent
Specimen line
10µL of whole blood
10 minutes
Result Interpretation
At Risk
Antibody titer
IgM negative
IgG250 IU/mL
IgG
IgM
IgG
<15 IU/mL
IgG15 IU/mL
Time
weeks
months
Result Interpretation
Acute Infection
Antibody titer
IgM positive
IgG250 IU/mL
IgG
infection
IgM
IgG15 IU/mL
Time
weeks
months
≥250
≥15
<15
IgG (IU/mL)
IgG<15 IU/mL
IgG ≥15 IU/mL
IgG ≥250 IU/mL
Result Interpretation
Protected/past infection
Antibody titer
IgM negative
IgG250 IU/mL
IgG
IgM
IgG
≥15 IU/mL
IgG15 IU/mL
Time
weeks
months
OnSite Rubella IgG/IgM RDT
Limit of Detection of the G1 and G2 Test Lines
• 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.
Limit of detection: G1 test line: 15 IU/mL
0
5
10
15
20
30
60
Number Positive
0
2
13
19
20
20
20
Number Negative
20
18
7
1
0
0
0
Total repeats
20
20
20
20
20
20
20
Limit of detection: G2 test line: 250 IU/mL
30
60
100
160
200
250
300
Number Positive
0
4
11
13
18
20
20
Number Negative
20
16
9
7
2
0
0
Total repeats
20
20
20
20
20
20
20
OnSite Rubella IgG/IgM RDT
Comparable to the Market Leading ELISA
• Performance of G1 test line on random clinical specimens
OnSite IgG/IgM Rubella Rapid Test
G1 Test Line Detection
Reference
ELISA
Positive
Positive
Negative
Total
171
3
174
Negative
2
38
40
Total
173
41
214
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
OnSite Rubella IgG/IgM RDT
Positive Rate Matches Literatures
• The OnSite Rubella IgG/IgM Rapid Test was evaluated with 10,000
random clinical specimens.
Positive rate
M Line
G1 Line
G2 Line
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%
OnSite Rubella IgG/IgM RDT
Correctly Detects BBI Rubella Performance Panel
• Has good agreement with the reference ELISA tests
• Has superior IgM specificity to a competitor Rapid Test
BBI Panel Test
(by Abbott ELISA )
Number of
Specimens
OnSite Rubella IgG/IgM Rapid Test
Competitor RDT
M
Positive
G1
Positive
G2
Positive
IgM
Positive
IgM Negative
20
0
0
0
4
IgM 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
OnSite Rubella IgG/IgM RDT
Low Cross-Reactivity
• The OnSite Rubella IgG/IgM Rapid Test has no false positive on
specimens from patients with other disease states
Disease states
CMV
Dengue
HAV
HBV
HCV
HIV
H. pylori
HSV-1
HSV-2
Syphilis
TB
Toxoplasma
ANA
HAMA
RF (up to 2,500IU/mL)
OnSite Rubella IgG/IgM Rapid Test
Specimens tested
Result (M, G1, G2)
5
6
10
10
10
5
10
5
5
9
6
3
6
4
14
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
OnSite Rubella IgG/IgM RDT
Low Risk of Interference
• The OnSite Rubella IgG/IgM Rapid Test has no interference from
common medicines and blood components.
Substances tested
Concentrations tested
Albumin
Bilirubin
Creatinine
EDTA
Glucose
Hemoglobin
Heparin
Salicylic Acid
60 g/L
20 mg/dL
442 μmol/L
3.4 µmol/L
55 mmol/L
2 g/L
3,000 U/L
4.34mmol/L
Sodium citrate
3.8%
OnSite Rubella IgG/IgM Rapid Test
A 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
2 steps
Multiple
Multiple
10 minutes
2-3 hours
2-3 hours
Equipment
No
Moderate
Expensive
Complexity
Minimal
Moderate
Moderate
2-30℃
4℃
4℃
Cost
Low
Moderate
High
Suitable for
screening
Yes
Yes/No
No
Procedure
Time to result
Storage
OnSite Rubella IgG/IgM Rapid Test
NOVEL & 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 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
Antibody titer
G2 line LOD at 250 IU/mL for accurate diagnosis of active infection
IgG250 IU/mL
IgG
IgM
IgG15 IU/mL
Time
weeks
months
Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739
QUALITY . INNOVATION . SIMPLICITY