Customization: | Available |
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Type: | IVD Reagent |
Certification: | CE, ISO13485 |
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Uncut sheet for One Step Rubella(RV) IgG/IgM Test is a qualitative membrane strip based immunoassay for the detection of RV antibodies (IgG and IgM) in Whole Blood /Serum / Plasma. The test device consists of: 1) a burgundy colored conjugate pad containing RV recombinant envelope antigens conjugated with Colloid gold (RV conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with the antibody for the detection of IgM anti-RV, T2 band is coated with antibody for the detection of IgG anti-RV, and the C band is pre-coated with goat anti rabbit IgG.
When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG anti-RV, if present in the
specimen, will bind to the RV conjugates. The immunocomplex is then captured by the reagent pre-coated on the T2 band, forming a burgundy colored T2 band, indicating a RV IgG positive test result and suggesting a recent or repeat infection. IgM anti-RV if present in the specimen will bind to the RV conjugates. The immunocomplex is then captured by the reagent coated on the T1 band, forming a burgundy colored T1 band, indicating a RV IgM positive test result and suggesting a fresh infection. Absence of any T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color
development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device.
1. Positive IgM Result The control line (C) and IgM line (M) are visible on the test device. This is positive for IgM antibodies to Rubella virus. It is indicative of a primary dengue infection.
2.Positive IgG Result The control line (C) and IgG line (G) are visible on the test device. This is positive for IgG antibodies. It is indicative of secondary or previous Rubellainfection.
3. Positive IgM and IgG Result The control line (C), IgM (M) and IgG line (G) are visible on the test device. This is positive for both IgM and IgG antibodies. It is indicative of a late primary or early secondary Rubella infection.
4.Negative Result The control line is only visible on the test device. It means that No IgG and IgM antibodies were detected.
5.Invalid Result No visible colored band appears at control line after performing the test. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the test procedure and repeat the test using a new test device.
Uncut Sheet of Rapid test Kit-Colloidal gold |
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Chlamydia |
C. pneumoniae |
H. Pylori |
Malaria |
Rotavirus |
Adenovirus |
Rota/Adeno |
Strep A |
Syphilis |
HBsAg |
HBsAb |
HBsAg and HCV |
HBsAg /HCV /HIV /Syphilis |
Dengue IgG/IgM |
Dengue Ns1 |
Dengue IgG/IgM /NS1 |
Chikungunya |
Cholera |
Typhoid |
Tuberculosis |
HIV1+2 |
HIV1+2 Ag/Ab |
HAV |
ToRCH |
HCV |
HSV |
RSV |
TOXO |
Rubella |
CMV |
Norovirus |
Leishmania |
Filariasis |
Leptospira |
Monkeypox |
M.Pneumoniae |
Chagas |
Brucella |
HPV |
nCoV |
Influenza A+B |
Influenza A+B/ nCoV |
Influenza A+B/nCoV/RSV |
FOB |
HCG | LH | IGFBP-1 | fFN |
AMH |
AMH/FSH |
MxA |
cTnI |
25-OH VD | The Customized cut -off and size are available |
Uncut Sheet of Lateral Flow Quantitive Test Kit | |||
Class |
Rapid Test |
Sample type |
Detection Range |
Cardiac Marker |
cTn I |
Serum/Plasma/Whole blood |
0.1~40 ng/mL |
NT-proBNP |
Serum/Plasma/Whole blood |
100~20000 pg/mL |
|
CK-MB |
Serum/Plasma/Whole blood |
1ng/mL~100ng/mL |
|
BNP |
Plasma/Whole blood |
5pg/mL~5000pg/mL |
|
cTnT |
Serum/Plasma/Whole blood |
30pg/mL~25000pg/mL |
|
Myo |
Serum/Plasma/Whole blood |
5ng/mL~500ng/mL |
|
cTnl/ Myo/ CK-MB |
Serum/Plasma/Whole blood |
cTnI: 0.1ng/mL~40ng/mL;Myo: 5ng/mL~500ng/mL;CK-MB: 1ng/mL~100ng/mL |
|
D-Dimer/ cTnI/ NT-proBNP |
Serum/Plasma/Whole blood |
Dimer: 0.1mg/L~10mg/L; cTnI: 0.1ng/mL~40ng/mL; NT-proBNP: 100pg/mL~20000pg/mL |
|
Inflammatory |
PCT |
Serum/Plasma/Whole blood |
0.1~100 pg/mL |
CRP |
Serum/Plasma/Whole blood |
0.5~200mg/L |
|
SAA |
Serum/Plasma/Whole blood |
5~300mg/L |
|
IL-6 |
Serum/Plasma/Whole blood |
5~5000 pg/mL |
|
PCT/ IL-6 |
Serum/Plasma/Whole blood |
PCT: 0.1ng/mL~100ng/mL;IL-6:10pg/mL~10000pg/mL |
|
CRP/ SAA |
Serum/Plasma/Whole blood |
CRP 0.5mg/L~200mg/L;SAA 5mg/L~300mg/L, |
|
Glycated hemoglobin |
HbA1c |
Whole blood |
3~14% |
Tumor |
PSA |
Serum/Plasma/Whole blood |
2~80 ng/mL |
HCG |
HCG |
Serum/Plasma/Whole blood |
5~200000mIU/mL |
Anticoagulation |
D-Dimer |
Plasma/Whole blood |
0.1~10 mg/L |
Endocrine |
TSH |
Serum/Plasma/Whole blood |
0.1mIU/L ~100.0mIU/L |
T3 |
Serum/Plasma/Whole blood |
0.61~9.22 nmol/L |
|
T4 |
Serum/Plasma/Whole blood |
12.87~310 nmol/L |
|
FT3 |
Serum/Plasma/Whole blood |
0.60pmol/L ~45.00pmol/L |
|
FT4 |
Serum/Plasma/Whole blood |
1.00pmol/L ~100.00pmol/L |
|
AMH |
Serum/Plasma/Whole blood |
0.1~16 ng/mL |
|
PROG |
Serum/Plasma |
0.35ng/mL~60ng/mL |
|
PRL |
Serum/Plasma/Whole blood |
1 ng/mL~200ng/mL |
|
FSH |
Serum/Plasma/Whole blood |
1mIU/mL~100 mIU/mL |
|
LH |
Serum/Plasma/Whole blood |
1 ~100 mIU/mL |
|
TES |
Serum/Plasma |
0.2~15 ng/mL |
|
E2 |
Serum/Plasma/Whole blood |
15 pg/mL~3000pg/mL |
|
Bone |
25-OH-VD |
Serum/Plasma/Whole blood |
5.0ng/mL~100.0ng/mL |
The Customized cut -off and size are available |