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HERPES SIMPLEX

The Herpes simplex virus (HSV) is a member of the Herpesviridae family, of which two types are known: type 1 (HSV-1) and type 2 (HSV-2) which present slight antigenic differences. HSV-1 causes chiefly oral-facial lesions, while HSV-2 is mainly responsible for genital lesions, but this distinction is not binding, both types occasionally causing infection in either anatomical site. HSV may also cause a form of ocular cheratitis, and lesions of the central nervous system. HSV can affect practically the whole population. The primary infection is often in a subclinical form and is rarely diagnosed. After a latency period of variable duration, reactivation may occur and viral replication may or may not give rise to clinical lesions. Infection contracted during birth is of particular interest, this being an important cause of morbidity and mortality. It is therefore important to determine the immunitary state of women during pregnancy in order to detect serum conversion. The assay of specific IgG is important to establish the serological state of the patient. The assay of specific IgM is important for the diagnosis of neonatal infection and encephalitis caused by HSV. Moreover, the presence of specific IgM indicates viral activity in progress, although it is not possible to distinguish between primary infection and reactivation.

Method:

Immunoenzymatic method for the qualitative determination of IgM and IgG-class antibodies to Herpes Simplex Type 1 and 2 in human serum. The test is based on the ELISA principle (Enzyme Linked ImmunoSorbent Assay) which uses the reaction between the antibodies present in the tested sample and the immobilized antigen bound to solid phases. The immunoglobulins bind to the antigen through incubation with diluted human serum. The result is expressed as an INDEX (ratio between the OD value of the sample and that of the Cut-off).

HERPES SIMPLEX 1+2 IgG

coated with herpes simplex virus

Kit for the determination of anti-Herpes simplex (type 1 and 2) IgG antibodies in human serum.
Code 91020
Quantity 96 tests
METHOD Indirect ELISA
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 100%
DIAGNOSTIC SPECIFITY 100% CI95%: 97.1. – 100
INCUBATION TIME 105 min
SHELF LIFE 15 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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HERPES SIMPLEX 1+2 IgM

coated with anti-human IgM monoclonal antibodies

Kit for the determination of anti-Herpes simplex (type 1 and 2) IgM antibodies in human serum. Capture method.
Code 91021
Quantity 96 tests
METHOD CAPTURE ASSAY
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 95.6%
DIAGNOSTIC SPECIFITY 97.8%
INCUBATION TIME 105 min
SHELF LIFE 15 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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CoA

HERPES SIMPLEX 1 IgG

coated with herpes simplex virus type 1

Kit for the determination of anti-Herpes simplex type 1 IgG antibodies in human serum.
Code 91027
Quantity 96 tests
METHOD Indirect ELISA
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 99.4% (CI95% 96.5-99.9)
DIAGNOSTIC SPECIFITY 86.7% (CI95%62.1-96.2%)
INCUBATION TIME 105 min
SHELF LIFE 15 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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HERPES SIMPLEX 1 IgG Recombinant

coated with HSV 1 IgG recombinant antigen, composed of recombinant G1 glycoprotein specific for Herpes Simplex Virus Type 1

Kit for the determination of anti-Herpes simplex type 1 IgG antibodies in human serum with recombinant antigen use.
Code 91023
Quantity 96 tests
METHOD Indirect ELISA
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 97.8% CI95%: 94.5-99.1
DIAGNOSTIC SPECIFITY 98.6% CI95%: 92.7-99.7
INCUBATION TIME 105 min
SHELF LIFE 15 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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CoA

HERPES SIMPLEX 1IgM

coated with anti-human IgM monoclonal antibodies

Kit for the determination of anti-Herpes simplex type 1 IgM antibodies in human serum. Capture method.
Code 91028
Quantity 96 tests
METHOD CAPTURE ASSAY
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 100% (CI95%: 72.3-100%)
DIAGNOSTIC SPECIFITY 98,6% (CI95%: 96.4-99.5%)
INCUBATION TIME 105 min
SHELF LIFE 15 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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HERPES SIMPLEX 2 IgG

coated with herpes simplex virus type 2

Kit for the determination of anti-Herpes simplex type 2 IgG antibodies in human serum.
Code 91026
Quantity 96 tests
METHOD Indirect ELISA
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 81.8% (CI95%: 61.5 - 92.7%)
DIAGNOSTIC SPECIFITY 90.7% (CI95%: 84.9 - 94.4%)
INCUBATION TIME 105 min
SHELF LIFE 15 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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CoA

HERPES SIMPLEX 2 IgG Recombinant

coated with HSV 2 IgG recombinant antigen, composed of recombinant G2 glycoprotein specific for Herpes Simplex Virus Type 2

Kit for the determination of anti-Herpes simplex type 2 IgG antibodies in human serum with recombinant proteine use.
Code 91029
Quantity 96 tests
METHOD Indirect ELISA
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 91.7% CI95%: 80.4- 96.6
DIAGNOSTIC SPECIFITY 97.5% CI95%: 94.7- 98.8
INCUBATION TIME 105 min
SHELF LIFE 15 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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CoA

HERPES SIMPLEX 2 IgM

coated with anti-human IgM monoclonal antibodies

Kit for the determination of anti-Herpes simplex type 2 IgM antibodies in human serum. Capture method.
Code 91025
Quantity 96 tests
METHOD Indirect ELISA
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 100% (CI95%: 64.6-100%)
DIAGNOSTIC SPECIFITY 98.2% (CI95%: 96.0-99.3%)
INCUBATION TIME 105 min
SHELF LIFE 15 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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IFU

SDS

CoA