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Hormone Neonatal

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CMV IgG/IgM Rapid Test

Features:

A lateral flow immunoassay for the simultaneous detection and differentiation of IgM and IgG antibodies to cytomegalovirus (CMV) in human serum, plasma or whole blood.
- Individually sealed foil pouches containing:
a. One cassette device b. One desiccant
- 10 µL capillary tubes
- Sample diluent (REF SB-R0224, 5 mL/bottle)
- One package insert (instructions for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0224C	CMV IgG/IgM Rapid Test	30/kit	S,P& WB

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Duo HSV-1/2 IgG/IgM Rapid Test CE

Features:

Clinical accuracy:
90.6% sensitivity and 91.4% specificity for anti-HSV-1 IgG detection
93.8% sensitivity and 96.0% specificity for anti-HSV-2 IgG detection
85.0% overall agreement for anti-HSV-1 IgM detection comparing to commercial ELISA
100% overall agreement for anti-HSV-2 IgM detection comparing to BBI Panel (PTH202)
Positive rate on random clinical specimens:8% for IgG anti-HSV-1 and 4.9% for IgM anti-HSV-1 (n=10,000); 4.6% for anti-HSV-2 IgG and 1.7% for anti-HSV-2 IgM
Cross reactivity: no cross reactivity with the following disease states or special conditions, respectively: palladium, H. pylori, Dengue, Malaria, Typhoid, Toxoplasma, Rubella, CMV, hCG, TB, HAV, HBV, HCV, HEV, HIV, ANA, HAMA, RF (up to 1,000 IU/mL)
Interference: No interference was seen with Albumin 60 g/L , Hemoglobin 2 g/L, Bilirubin 20 mg/dL, Heparin 3,000 U/L, Creatinine 442 µmol/L, Salicylic acid 4.24 mmol/L, EDTA 3.4 µmol/L, Sodium citrate 8%, Glucose 55 mmol/L
Shelf life: 24 months
ndividually sealed foil pouches containing:
- One cassette device
- One desiccant
Capillary tubes (10 µL)
Sample diluent (REF SB-R0203, 5 mL/bottle)
Package insert (instruction for use)

CATALOG #	PRODUCT	QUANTOTY	SPECIMEN
R0218C	Duo HSV-1-2IgG/IgM Rapid Test CE	20/kit	S,P& WB

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hCG Combo Rapid Test (strip) CE

Features:

Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is
- 100% sensitivity and 100% specificity in urine specimens
- 100% sensitivity and 99.5% specificity in serum specimens
Analytical sensitivity: 100% positive detection rate at 12.5 mIU/mL in serum/plasma specimens and 100% positive detection rate at 25 mIU/mL in urine specimens
Analytical specificity: no cross reactivity with 1,000 mIU/mL human luteinizing hormone (hLH), 1,000 mIU/mL human follicle stimulating hormone (hFSH), and 1,000 mIU/mL human thyroid stimulating hormone (hTSH)
Dose hook effect: no dose hook effect was observed for hCG at concentrations up to 500,000 mIU/mL in urine specimens
Interference: No interference was seen with 35 biological and chemical analytes commonly found in OTC, prescriptions or abuse drugs in urine or serum/plasma specimens, as well as pH 4-9 (see detail in the package insert)
Shelf life: 24 month
Kit box package:

1. Individually sealed foil pouches containing;

a. One dip strip device

b. One desiccant

2. One package insert (instruction for use)

Tube package:

1. Strip Package

2. One desiccant
3. One package insert (instruction for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R1001S	hCG Combo Rapid Test(strip) CE	50/kit,100/kit	S/Urine

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hCG Combo Rapid Test CE

Features:

- Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is
  - 100% sensitivity and 100% specificity in urine specimens
  - 100% sensitivity and 99.1% specificity in serum specimens
- Analytical sensitivity: 100% positive detection rate at 12.5 mIU/mL in serum/plasma specimens and 100% positive detection rate at 25 mIU/mL in urine specimens
- Analytical specificity: no cross reactivity with 1,000 mIU/mL human luteinizing hormone (hLH), 1,000 mIU/mL human follicle stimulating hormone (hFSH), and 1,000 mIU/mL human thyroid stimulating hormone (hTSH)
- Dose hook effect: no dose hook effect was observed for hCG at concentrations up to 500,000 mIU/mL in urine specimens
- Interference: No interference was seen with 35 biological and chemical analytes commonly found in OTC, prescriptions or abuse drugs in urine or serum/plasma specimens, as well as pH 4-9 (see detail in the package insert)
- Shelf life: 24 month
- - Individually sealed foil pouches containing:
  a. One cassette device
  
  b. One plastic dropper
  
  c. One desiccant
  - One package insert (instruction for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R1001C	hCG Combo Rapid Test CE	30/kit	S/Urine

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HSV-1 IgG/IgM Rapid Test CE

Features:

- Type-specific detection by utilizing glycoprotein G1.
- Single test that detects and differentiates IgG and IgM anti-HSV-1.
- High confidence as test is in agreement with market leading ELISA test: 90.7% IgG; 85.0% IgM.
- Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation.
- Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient.
- Initial treatment action can begin during the patient’s visit as test results are available in 10 minutes.
- Easily transported, and can be stored for 24 months, 2-30^oC.
- Individually sealed foil pouches containing:
  - One cassette device
  - One desiccant
- Capillary tubes (10 µL)
- Sample diluent (REF SB-R0203, 5 mL/bottle)
- Package insert (instruction for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0203C	HSV-1 IgG/IgM Rapid Test CE	30/kit	S,P& WB

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HSV-2 IgG/IgM Rapid Test CE

Features:

Unique test that utilizes glycoprotein G2 to differentiate between HSV-1. and HSV-2 that allows for an early start of treatment action.
Immediate determination of either acute or chronic infection by detecting and differentiating IgG and IgM anti-HSV-2.
High confidence as test is in agreement with market leading European ELISA: 95.3% IgG; 100% IgM.
Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation.
Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient.
Initial treatment action can begin during patient’s visit as test results are available in 10 minutes.
Easily transported, and can be stored for 24 months, 2-30^oC.
Individually sealed foil pouches containing:
- One cassette device
- One desiccant
Capillary tubes (10 µL)
Sample diluent (REF SB-R0213, 5 mL/bottle)
Package insert (instruction for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0213C	HSV-2 IgG/IgM Rapid Test CE	30/kit	S,P& WB

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Rubella IgG/IgM Rapid Test

Features:

For obstetric and symptomatic patient screening, an easy to use, fast, cost-effective test for determining specific antibody levels for Rubella
The first rapid test to discriminate between patients at risk for, protected from or currently experiencing rubella infection
Four line format allows simultaneous detection of IgM and IgG anti-rubella virus saving time and cost
Single test differentiates high (≥250 IU/mL) and low (15-250 IU/mL) IgG anti-rubella virus levels, no need for ELISA test
Ten minute test time reduces result turn around time
Standardized with the WHO 1st International Standard for anti-rubella immunoglobulin (RUBI-1-94)
High correlation with ELISA results on the BBI Mixed Titer Performance Panel PTR-201
Individually sealed foil pouches containing:
- One cassette device
- One desiccant
Capillary tubes (10 µL)
Sample diluent (REF SB-R0243, 5 mL/bottle)
Package insert (instruction for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0243C	Rubella IgG/IgM Rapid Test	30/kit	S,P& WB

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TORCH Panel Rapid Test

Features:

- Distinguishes between IgG and IgM in all five TORCH infections
- Compatible with serum, plasma, and whole blood
- Results available in 15 minutes
- Provides semi-quantitative results for Rubella IgG antibodies
- Distinguishes between HSV-1 and HSV-2
- Shelf life: 18 months
- Analytical Sensitivity of IgG Detection: Twenty negative specimens were spiked with appropriate reference standards at various concentrations. Specimens were run on the OnSite TORCH Panel Rapid Test panel member. Defined as the 95% detection level, the limits of detection, or sensitivity, were determined to be as follows:
1. Toxo: 5 IU/mL LOD; WHO International Standard Anti-Toxoplasma Serum Ig (TOXM)
2. Rubella: 15 IU/mL (G1); 250 IU/mL (G2); WHO 1^st International Standard (RUBI-1-94)
- Accuracy of IgG Detection in comparison with commercial ELISA: Clinical IgG positive specimens were collected and tested on each OnSite TORCH Panel Rapid Test panel member as well as by commercial ELISA. Comparison for all subjects showed the following overall agreements:
1. Toxo (237 specimens): 94.9%
2. Rubella (214 specimens): 97.7%
3. CMV (258 specimens): 93.4%
4. HSV-1 (227 specimens): 90.7%
5. HSV-2 (214 specimens): 95.3%
- Accuracy of IgM Detection in comparison with commercial ELISA: Clinical IgM positive specimens were collected and tested on each OnSite TORCH Panel Rapid Test panel member as well as by commercial Comparison for all subjects showed the following overall agreements:
1. Toxo (231 specimens): 98.8%
2. Rubella (25 specimens): 96.0%
3. CMV (212 specimens): 93.9%
4. HSV-1 (107 specimens): 85.0%
5. HSV-2 (26 specimens): 95.2%
- Cross Reactivity: No false positive IgG and IgM results were observed on 3-14 specimens from the following disease states or special conditions, respectively: Toxo, Rubella, CMV, HSV-1, HSV-2, hCG, HAV, HBV, HCV, HEV, HIV, TB, palladium, Dengue, Malaria, H. pylori, Typhoid, ANA, HAMA, and RF (>1,000 IU/mL).
During cross-reactivity testing for each TORCH infection, self-reactivity was not considered (i.e. rubella positive samples were not tested on the Rubella IgG/IgM Rapid Test). Specimens tested vary for each panel member of the OnSite TORCH Panel Rapid Test.
- Interference: No interference was seen from the following substances: Albumin 60 g/L; Bilirubin 20 mg/dL; Heparin 3,000 U/L; Hemoglobin 2 g/L; Creatinine 442 µmol/L; EDTA 3.4 µmol/L; Salicylic acid 4.34 mmol/L; Glucose 55 mmol/L; and Sodium citrate 3.8%.
Individually sealed foil pouches containing:
- One cassette device
- Two desiccants
Plastic droppers
Sample diluent (REF SB-R0253, 5 mL/bottle)
One package insert (instruction for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0253C	TORCH Panel Rapid Test	10/kit	S,P& WB

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Toxo IgG/IgM Combo Rapid Test

Features:

A lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-Toxoplasma gondii (T. gondii) in human serum, plasma or whole blood.
- Individually sealed foil pouches containing:
a. One cassette device

b. One desiccant
- 10 µL capillary tubes
- Sample diluent (REF SB-R0234, 5 mL/bottle)
- One package insert (instruction for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0234C	Toxo IgG/IgM Combo Rapid Test	30/kit	S, P &WB

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