Rapid Hormone Neonatal Tests

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The OnSite TORCH Panel Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to Toxoplasma gondii (T. gondii), rubella virus, cytomegalovirus (CMV), herpes simplex virus 1 (HSV-1), and herpes simplex virus 2 (HSV-2) in human serum, plasma, or whole blood. This test is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with T. gondii, rubella virus, CMV, HSV-1 and HSV-2. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device. The OnSite TORCH Panel Rapid Test detects and differentiates IgG and IgM antibodies for all 5 TORCH infections. In general, a negative test result indicates that the individual is at risk for acquiring a primary infection. A positive IgM result only indicates acute infection, a positive IgM and IgG test indicate acute, late phase infection, and a positive IgG test result only indicates past or chronic infection. The presence of IgM anti-rubella virus or high titers of IgG anti-rubella virus (> 200 IU/mL) are suggestive of acute rubella infection. Lower titers of IgG anti-rubella virus (≥ 10-15 IU/mL) are suggestive of previous exposure and protective immunity. An individual with an IgG anti-rubella virus titer less than 10-15 IU/mL is considered to be at risk of acquiring a rubella virus infection. 

Recommended for use:

• Any person presenting with clinical signs or symptoms consistent with TORCH infection.
• Women who are pregnant or who are planning to become pregnant
• Individuals with a compromised immune system

• Provides semi-quantitative results for Rubella IgG antibodies
• Distinguishes between HSV-1 and HSV-2
• 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.
• 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
• 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, 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%.

• Toxo (237 specimens): 94.9%
• Rubella (214 specimens): 97.7%
• CMV (258 specimens): 93.4%
• HSV-1 (227 specimens): 90.7%
• HSV-2 (214 specimens): 95.3%

• Toxo (231 specimens): 98.8%
• Rubella (25 specimens): 96.0%
• CMV (212 specimens): 93.9%
• HSV-1 (107 specimens): 85.0%
• HSV-2 (26 specimens): 95.2%

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The OnSite Toxo IgG/IgM Combo Rapid Test is 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.

Features:

• A lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-Toxoplasma gondii (T. gondii)
• One package insert (instruction for use)
• Individually sealed foil pouches containing: One dip strip device, One desiccant

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The OnSite Rubella IgG/IgM Rapid Test is a lateral flow immunoassay for the semi-quantitative detection and differentiation of antibodies (IgG and IgM) to rubella virus in human serum, plasma or whole blood.

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

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The OnSite HSV-2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood.

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

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The OnSite HSV-1 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 1 (HSV-1) in human serum, plasma or whole blood.

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.

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The OnSite Combo Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone in human serum, plasma and urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite Combo Rapid Test is not intended for quantitative results, nor for over the counter (OTC) sales. It is intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via assay of a placental hormone that may be present in human serum, plasma or urine. The detection limit of the OnSite Combo Rapid Test is 12.5 mIU/mL in serum or plasma specimen, and 25 mIU/mL in urine specimen. It is designed for professional use only, and provides only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

Features:

• Individually sealed foil pouches containing: One cassette device, One plastic dropper, One desiccant
• Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA
• 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 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)

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The OnSite Combo Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone in human serum, plasma and urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite Combo Rapid Test is not intended for quantitative results, nor for over the counter (OTC) sales. It is intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via assay of a placental hormone that may be present in human serum, plasma or urine. The detection limit the OnSite Combo Rapid Test is 12.5 mIU/mL in serum or plasma specimen, and 25 mIU/mL in urine specimen. It is designed for professional use only, and provides only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

Features:

• Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA detection is
• 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 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)

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The OnSite Duo HSV-1/2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. This test can be performed in 10 minutes by minimally skilled personnel without the use of laboratory equipment. This test is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with HSV-1 and/or HSV-2. The OnSite Duo HSV-1/2 IgG/IgM Rapid Test uses HSV-1 glycoprotein G1 and HSV-2 glycoprotein G2 for the specific detection and differentiation of IgG and IgM antibodies to HSV-1 and HSV-2 in serum, plasma and whole blood. An HSV-1 and/or HSV-2 IgM positive result indicates an active infection, which may be primary or recurrent. An HSV-1 and/or HSV-2 IgG positive result indicates a recent or past infection. However, a negative test result does not preclude the possibility of infection with HSV-1 and/or HSV-2. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.

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, 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

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The OnSite CMV IgG/IgM Rapid Test is 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. 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.