Gold Standard Diagnostics

Virotech Respiratory Panel

Adenovirus

5-8% of the world wide occuring acute infections of the upper and lower respiratory tract are caused by Adenovirus. The Virotech ELISA detects all types of Adenovirus.

Sera Collective (IgG n=300, IgM n=286)

ELISA Competitor	Virotech Adenovirus ELISA
	IgG		IgM
	Negative	Positive	Negative	Positive
Negative	91	18	190	3
Positive	0	164	5	62

	IgG	IgM
Sensitivity	>99.8%	92.5%
Specificity	83.5%	98.4%

Influenza A / Influenza B

By their ability of gene-change and the above average mutation-frequence Influeanza A and Influenza B viruses can change in a way, that every year new sub-types may appear. The vaccines are updated every year, and also the Virotech Influenza A and Influeanza b ELISAs are updated towards the new surface-antigens of the current pathogen.

Bordetella Pertussis / Pertussis Toxin IgG / IgM / IgA

Since the 1950th whooping cough epidemiesoccur only very seldom, as since then the Pertussis-Vaccines are used. As Screening Test Virotech offers the Bordetella Pertussis ELISA (FHA & PT antigen) and the high specific Bordetella pertussis LINE Immunoblot for confirmation. The sensitive and specific Pertussis Toxin ELISA can be recommended for the diagnosis of the disease with the ability to interprete and present results using FDA-units. Exclusively the Pertussis Toxin is used as antigen for this kit.

Virotech LINE IgG/IgA	Virotech Pertussis Toxin ELISA
	IgG		IgM
	Negative	Positive	Negative	Positive
Negative	76	1	105	11
Positive	2	56	2	17

	IgG	IgM
Sensitivity	>96.6%	89.5%
Specificity	98.7%	90.5%

Mycoplasma pneumoniae

As most important pathogen of the atypical pneumoniae it is very important to differentiate between reinfections and past infections of Mycoplasma pneumoniae, especiallyin regard to treatment with antibiotics. As it is a bacteria lackingcellwall, β-Lactam-Antibiotics are not effective and do rather lead to a selection advantage for Mycoplasma. Thus, a differenciation against other pathogens like Bordetella pertussis is important.
Also for this respiratory disease, the IgM determination as acute marker is rather suitable for younger patients than for older, as those do not develop an IgM response in 60 % of the cases. As alternative the detection of IgA antibodies can be used.
By monospecific sera the antigen-homogenity of the Virotech ELISA is ensured. In addition to membrane proteins and cytoskeleton-proteins also recombinant proteins are added. Using this antigen and a special cut-off adjustment for infants, a sensitive and specific diagnostic is highly ensured.

		Mycoplasma ELISA
		IgG (n=129)		IgA (n=133)		IgM (n=132)
		negative	positive	negative	positive	negative	positive
Virotech Mycoplasma WB	negative	99	6	93	15	121	2
	positive	4	7	1	7	3	0
Analytic Specificity		94.3%		86.1%		98.4%

 

		Mycoplasma ELISA
		IgG (n=40)		IgA (n=40)		IgM (n=40)
		negative	positive	negative	positive	negative	positive
Virotech Mycoplasma WB	negative	10	2	17	1	10	0
	positive	1	21	3	12	1	25
Analytic Sensitivity		95.5%		(*)		96.2%

(*) Due to the low amount of positive sera a procentual statement of the analytical sensitivity does not make sense.

Parainfluenza 1 / Parainfluenza 2 / Parainfluenza 3

The Parainfluenza Viruses are divided into four groups. However only types 1 - 3 have a diagnostics meaning in Europe due to severeness of the disease. Mainly in finfants below the age of 4 years Parainfluenza 1 & 2 may lead to Pseudo-Krupp. Parainfluenza 3 rather causes Bronchiolitis and Pneumonia. The IgM detection test is not reliable, however a positive result gives notice towards and acute infection. Beside IgG also IgA shall be tested alternatively. Titer courses can also be a tool, besides others, for bone marrow recipients.

The following tables show the prevalence of blood donor sera:

Parainfluenza1

	IgG		IgM		IgA
	No.	%	No.	%	No.	%
Negative		8.8	79	98.8	76	95
Borderline	11	13.8	0	0	1	1.3
Positive	62	77.5	1	1.2	3	3.7

Parainfluenza 2

	IgG		IgM		IgA
	No.	%	No.	%	No.	%
Negative		15	80	100	116	96.6
Borderline	13	10.8	0	0	2	1.7
Positive	89	74.2	0	0	2	1.7

Parainfluenza 3

	IgG		IgM		IgA
	No.	%	No.	%	No.	%
Negative		0	80	100	115	95.8
Borderline	0	0	0	0	3	2.5
Positive	80	100	0	0	2	1.7

Parascreen

The Parainfluenza Scree Assay detects types 1 - 3 in one test run. The prevalence of blood donor sera is exemplified shown in the following tables:

	IgG		IgM		IgA
	No.	%	No.	%	No.	%
Negative	0	0	79	98.8	66	82
Borderline	0	0	0	0	6	7.5
Positive	80	100	1	1.2	8	10

RSV

Besides Measles, RSV belongs to the most important viral diseases of infants and is a main reason for hospitalisation. It is an important pathogen of Bronchitis and intestitial pneumonia also in older patients or seniors. The following table exemplified shows the performance data of the Virotech ELISA compared to a test of the competitor.

	Virotech IgG		Virotech IgM		Virotech IgA
	No.	%	No.	%	No.	%
Sensitivity	279	>95	295	>95	317	>95
Specificity	279	>95	295	>95	317	>95

Remark:
The mentioned data are to be understood as part of the performance data.
Borderline results have not been considered for the calculation.

Respiratory Panel
Adenovirus ELISA IgG/IgM Testkit (EC121.00) IgA Set (EC121.08)	Parainfluenza 1 ELISA IgG/IgM Testkit (EC145.00) IgA Set (EC145.08)
Bordetella Pertussis ELISA IgG/IgA Testkit (EC115.00) IgM Testkit (EC215M00)	Parainfluenza 2 ELISA IgG/IgM Testkit (EC146.00) IgA Set (Ec146.08)
Pertussis Toxin ELISA IgG Testkit (EC215G00) IgA Testkit (EC215A00) IgM Testkit (EC215M00)	Parainfluenza 3 ELISA IgG/IgM Testkit (EC147.00) IgA Set (EC147.08)
Influenza A ELISA IgG/IgM Testkit (EC118.00) IgA Set (EC118.08)	ParaScreen ELISA IgG/IgM Testkit (EC148.00) IgA Set (EC148.08)
Influenza B ELISA IgG/IgM Testkit (EC119.00) IgA Set (EC119.08)	RSV ELISA IgG/IgM Testkit (EC107.00) IgA Set EC107.08)
Mycoplasma pneumoniae IgG/IgM Testkit (EC114.00) IgA Set (EC114.08)

Advantages of the Virotech ELISAs - Diagnostics in a System

• color coded wells per parameter
• general IgG, Igm, and IgA conjugates
• ready to use components (except the wash buffer)
• identical serum dilution, incubation and interpretation
• identical, user friendly incubation times 30-30-30 Min.
• broad ELISA product range for the detection of antibodies
• broad CSF-ELISA product range for the detection of antibodies