En 5 Kit CoNtENts, PrEParatioN for usE aNd storagE



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EN

5           Kit CoNtENts, PrEParatioN for usE aNd storagE

The Wellcogen

TM

 Bacterial Antigen Kit includes sufficient reagents to perform 



30 tests.

See also Precautions, section 6.

All components should be stored at 2 to 8°C under which condition they will 

retain their activity until the expiry date of the kit.

Before use, bring all reagents to room temperature (18 - 30°C) and mix. Return 

the unused reagents to the refrigerator after use.

       instructions for use

 

disposable reaction Cards (2 packs)

 

disposable Mixing sticks (5 bundles)

 

disposable droppers (1 container)

Black rubber teat (1)

 

test Latexes

Strep B (pink cap)

H. influenzae b (pale blue cap)

S. pneumoniae (yellow cap)

N. meningitidis ACY W135 (grey cap)

N. meningitidis B/E. coli K1 (brown cap)

Five dropper bottles, one specific for each of the 

groups above, containing 0.5% suspensions of 

polystyrene latex particles in buffer containing 

0.05% Bronidox

®

 and/or 0.1% sodium azide as 



preservative. The latex particles are coated with 

the appropriate rabbit antibody, as labelled, 

except for the N. meningitidis group B/E. coli K1 

reagent, which is coated with murine monoclonal 

antibody.

Control Latexes

5 dropper bottles (dark blue cap) containing 

0.5% suspensions of polystyrene latex particles 

in buffer containing 0.05% Bronidox

®

 and/or 0.1% 



sodium azide as preservative. The latex particles 

are coated with an appropriate preparation of 

rabbit globulin or in the case of the N. meningitidis 

group B/E. coli K1 latex, a murine monoclonal 

antibody raised against Bordetella bronchiseptica.

The latex suspensions are provided ready for use 

and should be stored at 2 to 8°C in an upright 

position, until the expiry date of the kit. After 

prolonged storage some aggregation or drying 

of the latex may have occurred around the top of 

the bottle. Under these circumstances the bottle 

of latex should be shaken vigorously for a few 

seconds until resuspension is complete. DO NOT 

FREEZE.


Polyvalent Positive Control

Two bottles (blue cap) containing freeze-dried 

bacterial extracts containing antigens from 

representative strains of each bacterial species 

for which latex is provided. Contains 0.01% 

bronopol before reconstitution and 0.004% when 

reconstituted.

Reconstitute using 3.6 ml of sterile distilled water. 

After the addition of water allow the bottle to 

stand for a few minutes and then swirl to mix. 

Store reconstituted antigen at 2 to 8°C for up to 

6 months.



Negative Control

One dropper bottle (white cap) containing Glycine 

saline buffer, pH 8.2, with 0.05% Bronidox

®

 as 



preservative.

6 PrECautioNs

The reagents are for in vitro diagnostic use only.

For professional use only.

Please refer to the Safety Data Sheet (SDS) and product labelling for 

information on potentially hazardous components.

Wellcogen

tM

 Bacterial Antigen Kit

ZL26/R30859602 .....................30 Tests





iNtENdEd usE

The Wellcogen

TM

 Bacterial Antigen Kit provides a series of rapid latex tests 



for use in the qualitative detection of antigen from Streptococcus group B, 

Haemophilus influenzae type b, Streptococcus pneumoniae (pneumococcus), 

Neisseria meningitidis (meningococcus) groups A, B, C, Y or W135 and 

Escherichia coli K1 present in cerebrospinal fluid (CSF) as a consequence of 

infection. The kit can also be used to test other body fluids or blood culture 

supernatants for most of these antigens and plate cultures for N. meningitidis 

group B or Escherichia coli K1. (See Table 1 for indications supported by 

clinical data).

NOTE: Tests performed directly on clinical specimens are intended for 

screening purposes and should augment, not replace, culture procedures. 

Results must be used in conjunction with other data; e.g. symptoms, results 

of other tests, clinical impressions etc.



2 suMMary

Meningitis has a wide variety of potential causes, either infectious or non-

infectious. If bacterial meningitis is not treated promptly and effectively, the 

disease is likely to be fatal. Early identification of the infecting agent can be 

of considerable value in providing the patient with appropriate and adequate 

chemotherapy. Many bacterial species have been implicated in meningitis. 

Streptococcus group B and E. coli K1 are two of the most common causes 

of neonatal sepsis whilst in older age groups the commonest isolates are 

H. influenzae type b, S. pneumoniae and N. meningitidis groups A, B, C, Y 

and W135. These organisms carry specific polysaccharide surface antigens, 

a quantity of which diffuses into culture media or body fluids such as CSF or 

serum, and is excreted in the urine. The antigens can be detected by sensitive 

immunological methods such as counterimmuno-electrophoresis and latex 

agglutination

2,5,6,10

.



PriNCiPLE of thE tEst

The Wellcogen

TM

 reagents consist of polystyrene latex particles which 



have been coated with antibodies to the bacterial antigens. These latex 

particles agglutinate in the presence of sufficient homologous antigen. The 

Streptococcus and H. influenzae reagents are group B and type b specific 

respectively, the S. pneumoniae reagent is sensitised with antibodies purified 

from an omnivalent serum and the N. meningitidis polyvalent reagent reacts 

with groups A, C, Y and W135 antigens. Meningococcus group B antigen is 

more difficult to detect

6

 as well as being structurally and immunologically 



related to E. coli K1 antigen

7

; both of these react with the N. meningitidis 



group B reagent.



syMBoL dEfiNitioNs

Catalogue Number

In Vitro Diagnostic Medical Device

Contains sufficient for tests

Consult Instructions for Use

Temperature Limitation

Batch Code

Use By


Manufacturer

Add water

Key Code TSMX7713B

www.oxoid.com/ifu

Europe +800 135 79 135 

US 1 855 2360 190

CA 1 855 805 8539   

ROW +31 20 794 7071



HEALTH AND SAFETY INFORMATION

6.1 


The Test and Control Latexes for Streptococcus group B, H. influenzae 

type b, S. pneumoniae and N. meningitidis ACY W135  contain 0.1% 

sodium azide.  Azides can react with copper and lead used in some 

plumbing systems to form explosive salts. The quantities used in this kit 

are small; nevertheless when disposing of azide-containing materials 

they should be flushed away with large volumes of water.

6.2 

In accordance with the principles of Good Laboratory Practice it is 



strongly recommended that body fluids should be treated as potentially 

infectious and handled with all necessary precautions.

6.3 

When handling radiometric blood culture medium, the basic rules of 



radiation safety should be followed. These include:

a) Radioactive material should be stored in a designated area in an

approved container.

b) Handling of radioactivity should take place in a designated area.

c)

No mouth pipetting of radioactive material should be carried out.



d) No eating, drinking or smoking should take place in the designated

area.


e) Hands should be washed thoroughly after using radioactive material.

f)

The local Radiation Safety Officer should be consulted concerning



disposal requirements.

6.4 


Non-disposable apparatus should be sterilised by any appropriate 

procedure after use, although the preferred method is to autoclave for 

15 minutes at 121°C. Disposables should be autoclaved or incinerated. 

Spillage of potentially infectious materials should be removed 

immediately with absorbent paper tissue and the contaminated areas 

swabbed with a standard bacterial disinfectant or 70% alcohol. Do 

NOT use sodium hypochlorite. Materials used to clean spills, including 

gloves, should be disposed of as biohazardous waste.

6.5 

Do not pipette by mouth. Wear disposable gloves and eye protection 



while handling specimens and performing the assay. Wash hands 

thoroughly when finished.

6.6 

When used in accordance with the principles of Good Laboratory 



Practice, good standards of occupational hygiene and the instructions 

stated in these Instructions for Use, the reagents supplied are not 

considered to present a hazard to health.

ANALYTICAL PRECAUTIONS

6.7 

Do not use the reagents beyond the stated expiry date.



6.8 

Latex reagents should be brought to room temperature (18 to 30°C) 

before use. Latex reagents which show signs of aggregation or 

‘lumpiness’ before use may have been frozen and must not be used.

6.9 

It is important when using dropper bottles that they are held vertically 



and that the drop forms at the tip of the nozzle. If the nozzle becomes 

wet an incorrect volume will form around the end and not at the tip; 

if this occurs dry the nozzle before progressing.

6.10  The reagents provided with each kit are matched in performance and 

should not be used in conjunction with reagents from a kit having a 

different lot number.

6.11  Do not touch the reaction areas on the cards.

6.12  Mechanical rotators may be used in this assay. The following 

characteristics have been found to be satisfactory:

i)

Orbital rotators (also known as dimensional rotators) operating at 25 



rpm with approximate rotating angle of 9 to 10.5 degrees or operating 

at 18 rpm with a rotating angle of 16 to 17.5 degrees.

6.13  Avoid microbial contamination of reagents as this may lead to 

erroneous results.





sPECiMEN CoLLECtioN aNd storagE

7.1 


Body fluid samples (e.g. CSF, serum, urine) should be tested as soon 

after collection as possible. If the fluid cannot be tested immediately 

it may be stored overnight at 2 to 8°C, or for longer periods frozen at 

–15 to –25°C. If bacteriological analyses are required on the sample, 

these should be set up prior to performing the latex test, to avoid 

contaminating the sample.

7.2 

Blood cultures may be sampled and tested after 18 to 24 hours 

incubation at 37°C and/or as soon as bacterial growth is observed.

7.3 

Plate cultures (N. meningitidis B/E. coli K1 only). Isolated colonies 

growing on enriched agar medium (e.g. blood, chocolate agar) may 

be tested after overnight incubation at 37°C. A Gram stain should be 

performed to assist with the interpretation of the latex test result.





tEst ProCEdurE

REqUIRED MATERIALS PROVIDED

 See 

Kit Contents, section 5.

MATERIALS REqUIRED BUT NOT PROVIDED

Boiling water bath

Laboratory centrifuge or membrane filters (0.45 µm)

Rotator (optional – refer to Precautions, section 6)

PREPARATION OF CLINICAL SPECIMENS

8.1 

Body fluid samples must be heated before testing by the Wellcogen

TM

 



procedure to minimise non-specific reactions

4,6


. The following 

procedures are recommended:

a) For CSF and urine, heat the sample for 5 minutes in a boiling

water bath. Cool the sample to room temperature (18 to 30°C) 

and clarify by centrifugation or membrane filtration (0.45 µm) 

prior to testing. For maximum sensitivity urine samples may be 

concentrated up to 25-fold in a Minicon

®

 B-15 concentrator.  



Clarify as above before testing.

b) For serum, add 3 volumes 0.1 M disodium ethylenediaminetetra-

acetate (EDTA) pH 7.4 per 1 volume serum, heat the sample for 5 

minutes in a boiling water bath, cool to room temperature (18 to 30°C) 

and clarify as above. A suitable EDTA solution (10 ml) is available (Code 

No. ZL29/R30164501).

8.2 

Blood cultures. Centrifuge a 1 to 2 ml sample to pellet the red blood 

cells, for example at 1000 g for 5 to 10 minutes. Perform the latex test 

on the supernatant.

If a non-specific reaction occurs with a blood culture supernatant (see 



interpretation of results, section 10), heat the sample in a boiling 

water bath for 5 minutes, cool to room temperature (18 to 30°C), 

clarify by centrifugation and repeat the test.

8.3 


Plate cultures (N. meningitidis B/E. coli K1 only). Test directly from 

the culture plate.

 PROCEDURE

It is recommended that the section on Precautions, section 6, is read carefully 

before performing the test.

Body fluid samples and Blood culture supernatants:

NOTE: If there is only a limited volume of test sample available, it should be 

used with the Test Latexes first and if a positive result is obtained the sample 

should be tested with the appropriate Control Latex. If sufficient sample 

is available, it should be tested against both the Test and Control Latexes 

simultaneously.



step 1 

Process the sample as described under



Preparation of Clinical specimens.

step 2 

Shake the latex reagents.



step 3 

Place 1 drop of each test Latex or Control Latex  



1 drop

into a separate circle on a Reaction Card. Ensure 

that the dropper bottles are held vertically to dispense 

an accurate drop. (See Precautions, section 6).



step 4 

Using a Disposable Dropper, dispense 1 drop  



1 drop

(approximately 40 µl) of test sample next to each 

drop of latex.

step 5 

Mix the contents of each circle with a Mixing Stick 

and spread to cover the complete area of the circle. 

Use a separate stick for each circle and discard it for 

safe disposal after use.



step 6 

rock the card slowly and observe for agglutination  

3 mins

for 3 minutes, holding the card at normal reading 

distance (25 to 35 cm) from the eyes. Do not use a 

magnifying lens. Mechanical rotation (3 minutes) may 

be used (See Precautions, section 6). The patterns 

obtained are clear cut and can be recognised under all 

normal lighting conditions.

step 7 

Discard the used Reaction Card for safe disposal.



For tests with blood cultures a sample of uninoculated blood culture medium 

from the same source as the specimen should be used as a negative control. 

Note: testing uninoculated media is important as false-positives can occur 

with some formulations of blood culture media.



Notes:

a)  Previously assayed positive and negative samples, aliquoted and 

stored at –15 to –25°C or below, may be used as positive and negative 

controls respectively, if desired. The Positive Control can also be used 

in place of the test sample.

b)  For colony identification tests (Wellcogen

TM

 N. meningitidis B/E. coli K1 



only), the performance of the Test and Control Latex reagents may 

be confirmed using fresh, overnight cultures of reference strains 

of bacteria, following the method described in test Procedure

Suitable reference strains are:

 

ATCC 13090 – N. meningitidis group B (positive reactivity)



 

ATCC 23503 – E. coli type K1 (positive reactivity)

 

ATCC 13077 – N. meningitidis group A (negative reactivity)



 

ATCC 13090 and ATCC 23503 should give agglutination with the 

Test Latex and no significant agglutination in the Control Latex, 

ATCC 13077 should give no significant agglutination with either the 

Test or Control Latex.

10 rEsuLts

 

READING OF RESULTS



positive reaction is indicated by the development of an agglutinated pattern 

within 3 minutes (20 seconds for colony testing) of mixing the latex with the 

test sample, showing clearly visible clumping of the latex particles (Figure 1).

The speed of appearance and quality of agglutination depend on the strength 

of the antigen, varying from large clumps which appear within a few seconds of 

mixing, to small clumps which develop rather slowly. In culture identification, 

most positive reactions will be almost instantaneous.

In a negative reaction the latex does not agglutinate and the milky appearance 

remains substantially unchanged throughout the test (Figure 2). Note, 

however, that faint traces of granularity may be detected in negative patterns, 

depending on the visual acuity of the operator. In culture identification, some 

strains may cause a “stringy” aggregation of the latex with a milky background; 

this should be interpreted as a negative reaction.

NOTE: The latex particles used in the Wellcogen

TM

 N. meningitidis B/E. coli K1 



Test and Control Latex suspensions are not the same as those used for the 

other reagents, and give a finer agglutination.

 

Figure 1 



Figure 2

 

INTERPRETATION OF RESULTS



Positive result

Clear agglutination of a single Test Latex accompanied by negative reactions 

with all other Test Latex reagents and the Control Latex indicates the presence 

and identity of a bacterial antigen in the test sample. As a general rule a 

positive result with Wellcogen

TM

 N. meningitidis B/E. coli K1 against a neonatal 



specimen suggests E. coli K1 infection; with older patients, meningococcus 

group B is more likely.



Negative result

Negative reactions with all the Test Latex reagents indicates the absence of a 

detectable level of the bacterial antigens in the test fluid – it does not eliminate 

the possibility of an infection caused by these organisms, and if symptoms 

persist it may be desirable to perform the test on subsequent or alternative 

specimens, or after concentration of the urine specimen.

With a culture, lack of agglutination in Wellcogen

TM

 N. meningitidis B/E. coli K1 



reagents indicates that it is unlikely to be N. meningitidis group B or E. coli K1.

Plate Cultures:

(Wellcogen

TM

 N. meningitidis B/E. coli K1 only):



step 1 

Shake the latex reagents.



step 2 

For each culture to be tested place 1 drop of  



1 drop

 

test Latex in one circle on a Reaction Card and 1 

 

drop of Control Latex in a separate circle. 



 

NOTE: it is essential to use the Control Latex for 

 

suspected E. coli  cultures.



step 3 

Take a Mixing Stick and pick up some of the culture  



sample

 

by touching it with the flat end of the stick. As a guide, 



of

 

an amount of growth roughly equivalent to 1 large 



growth

 

colony should be picked.



step 4 

Emulsify the sample of culture in the drop of test 

 Latex 

by rubbing with the flat end of the stick. Rub 

 

thoroughly, but not so vigorously as to damage the 



 

surface of the card. Spread the latex to cover as much 

 

of the circle as possible. Discard the Mixing Stick for 



 

safe disposal.



step 5 

Using a separate stick, emulsify a similar sample of 

 

culture in the Control Latex.



step 6 

rock the card slowly and observe for agglutination  

20 secs

 

for 20 seconds holding the card at normal reading 



 

distance (25 to 35 cm) from the eyes. Do not use a 

 

magnifying lens. The patterns obtained are clear cut 



 

and can be easily recognised under all normal 

 

lighting conditions.



step 7 

Discard the used Reaction Card for safe disposal.





QuaLity CoNtroL

The following procedures should be carried out initially with each shipment of 

test kits and with each run of test samples. In practice, a run may be defined 

as a testing period of up to 24 hours. Any departure from the expected results 

indicates there may be a problem with the reagents, which must be resolved 

before further use with clinical samples.

 

VISUAL INSPECTION



The latex suspensions should always be inspected for aggregation as they are 

dropped onto the test card and if there is evidence of clumping before addition 

of the test sample, the suspension must not be used. After prolonged storage 

some aggregation or drying may have occurred around the top of the bottle. 

If this is observed, the bottle should be shaken vigorously for a few seconds 

until resuspension is complete.

 

POSITIVE CONTROL PROCEDURE



The reactivity of the test can be confirmed by adding Polyvalent Positive 

Control to a reaction circle in which the test sample has not agglutinated the 

Test Latex after 3 minutes rotation.

step 1 

Use a Disposable Dropper to add 1 drop of Positive  



1 drop

 

Control to the circle containing Test Latex and 



 specimen.

step 2 

Mix using a Mixing Stick and discard it for safe 

 disposal.

step 3 

Rock the card manually or by a rotator for a further  



3 mins

 

3 minutes. After this time, definite agglutination 



 

should be visible in the Test Latex.



step 4 

Discard the used Reaction Card for safe disposal.

 

NEGATIVE CONTROL PROCEDURE



If at least one test sample within a run gives a negative result with Test and 

Control Latexes (or Test Latex only where no Control Latex has been used), 

this constitutes a valid negative control for the reagents and no further 

testing is necessary.

If a test sample gives agglutination with the Test Latex and no agglutination 

with the Control Latex then the Test Latex should be tested either with the 

Negative Control or uninoculated blood culture medium, as appropriate 

(see below).



step 1 

Place one drop of Test Latex in one circle on a  



1 drop

 

Reaction Card.



step 2 

Dispense one drop of Negative Control or   



1 drop

 

uninoculated blood culture medium next to the Test 



 Latex.

step 3 

Mix using a Mixing Stick and discard it for safe 

 disposal.

step 4 

Rock the card manually or by a rotator for a further 



3 mins

 

3 minutes. After this time, there should be no 



 

significant agglutination in the Test Latex.



step 5 

Discard the used Reaction Card for safe disposal.

For tests with body fluid samples, the Negative Control provided with the 

kit should be used.



Non-interpretable result

Agglutination of more than one Test Latex reagent or corresponding Test and 

Control Latexes indicates a non-specific reaction. In most cases, non-specific 

reactions with body fluids may be eliminated by heating and clarifying the 

sample

4

 (see Preparation of Clinical specimens, section 8). If a non-specific 



reaction occurs with a blood culture supernatant, heat the sample in a boiling 

water bath for 5 minutes, cool to room temperature (18 to 30°C), clarify by 

centrifugation and repeat the test.

11 

PErforMaNCE LiMitatioNs

11.1  for infant body fluids (Group B strep only) – False negative test results 

may occur with specimens containing levels of antigen below the limits 

of detection of this device. Negative results should be followed up 

with selective broth culture. A positive result indicates the presence of 

Group B streptococcal antigen; the result does not necessarily indicate 

the presence of viable organisms.

11.2  for infant body fluids (Group B strep only) – Use of this device should 

not substitute for microbiological culture. Performance of this device 

for predicting Group B streptococcal disease from tests of infant urine 

has not been established.

11.3  Group B streptococcus infections occur primarily in neonates. Positive 

results obtained with body fluid samples from patients older than six 

months should be interpreted with caution. Positive results obtained 

with blood culture supernatants from patients of any age may be 

significant.

11.4  A positive result in the test depends on the presence of a detectable 

level of antigen in the body fluid or blood culture medium.

11.5  Limited clinical data are available for the detection of antigen in urine 

or serum using Wellcogen

TM

 N. meningitidis B/E. coli K1 (Table 6). No 



clinical data is available for the detection of antigen in urine using 

Wellcogen

TM

 N. meningitidis ACY W135 (Table 5). However, antigen 



has been reported in urine ACY W135 samples

5

.



11.6  A few examples have been reported of unrelated bacteria which 

possess common antigens and, as with any immunological test system, 

the possibility of cross reactions occurring in the latex test can not be 

ruled out

1,3,8,9

.

12 



ExPECtEd rEsuLts

Samples containing a detectable level of group B streptococcal antigen, H. 

influenzae type b antigen, S. pneumoniae capsular antigen, N. meningitidis 

A, C, Y, W135 antigens, or N. meningitidis B / E. coli K1 antigen will give an 

agglutination reaction with the appropriate Test Latex.

13 

PErforMaNCE CharaCtEristiCs

13.1  Body fluids and Blood Cultures

 

Clinical studies were carried out in 15 centres using body fluid 



samples (fresh and stored frozen) and blood culture supernatants. 

Both traditional and radiometric cultural techniques were used in 

the blood culture studies. Stored body fluid samples were not heat 

treated as described under Preparation of Clinical specimens, section 



8. Extensive laboratory testing has shown no significant loss of antigen 

after heating by this procedure.



 sensitivity

 

The sensitivity of each latex in the kit was established from tests on 



samples culture positive for the homologous organism or for which 

there was other evidence of infection (clinical diagnosis plus other 

antigen test positive).

 

Tables 2 to 6 show the numbers of each type of specimen tested 



with the individual latexes together with the number of positive 

results obtained. The sensitivity of each latex in detecting bacterial 

antigen in CSF was 67% (12/18) for Wellcogen

TM

 Strep B, 97% (87/90) 



for Wellcogen

TM

 H. influenzae b, 88% (45/51) for Wellcogen



TM

 

S. pneumoniae, 71% (29/41) for Wellcogen



TM

 N. meningitidis ACY 

W135 and 65% (11/17) for Wellcogen

TM

 N. meningitidis B/E. coli K1.



 specificity

 

The specificity of each of the Wellcogen



TM

 reagents was evaluated using 

body fluid (fresh and frozen) and blood culture samples from patients 

with bacterial or aseptic meningitis and other unrelated conditions.

 

The organisms isolated from the infected samples were H. influenzae b, 



S. pneumoniae, N. meningitidis including groups A, B, C, Y, E. coli, 

Staphylococcus aureus, Enterobacter aerogenes, Klebsiella 

pneumoniae, Mycobacterium tuberculosis, Proteus mirabilis, 

Staphylococcus epidermidis, alpha-haemolytic streptococcus, beta-

haemolytic streptococcus group A, Klebsiella oxytoca, Pseudomonas, 

Streptococcus sanguis, Toxoplasma gondii and a coliform bacterium.

 

The specificity of all five Wellcogen



TM

 latexes in tests on CSF was greater 

than 98%. Details of the number of samples tested and the specificity 

of each Wellcogen

TM

 with each type of specimen are given in tables 2 



to 6.

13.2  Plate Cultures (N. meningitidis B/E. coli K1).

 

N. meningitidis and E. coli cultures grown on an enriched agar medium 



were tested in hospital laboratories and In-house. All N. meningitidis 

group B and E. coli K1 cultures were correctly identified. There were no 

cross-reactions with other groups of N. meningitidis or other E. coli K 

antigens (Table 7). A high proportion of the E. coli cultures with other 

K antigens which were tested gave non-specific reactions (Table 7).

table 1

specimens which have been evaluated with 

individual Wellcogen

tM

 latex reagents

Specimen     Wellcogen

TM

 

Strep. B  H. influenzae b  S. pneumoniae  N. meningitidis 



N. meningitidis B/

 

 



 

 

ACY W135 



E. coli K1

CSF 


+ + 



+

Serum 




 +*


Urine 



 +* 


 +*

Blood Culture 





+

Bacterial colonies 



– 

– 

– 



– 

+

Key



Data available to support this application.

+* 

Limited data available.



– 

No data available.



table 2

results of clinical studies on Wellcogen

tM

 strep B

 Sensitivity

a

 Specificity



b

Sample 


No. tested  No. positive  No. tested  No. positive

CSF 


18 12 58  1

c

Serum 



19 13  7  0

Urine 


20 17 22 1

d

Blood Culture 



369 



4

e

a



  beta-haemolytic streptococcus group B isolated/indicated (clinical diagnosis/

other antigen test).

b

  Bacteria other than Strep. B/no growth.



c

  E. coli isolated.

d

  P. mirabilis isolated.



e

  Staph. epidermidis; beta-haemolytic strep. group A; E. coli + Enterococcus; 

Staph. epidermidis + Enterococcus isolated.

table 3

results of clinical studies on Wellcogen

tM

 h. influenzae b

 

Sensitivity Specificity



Sample 

No. tested  No. positive  No. tested  No. positive

CSF 

90  87 375



a

 2

b



Serum 

21 20 21  0

Urine 

10 10 236 0



Blood Culture 

54 


54 

1566


c

 5

d



a

  One additional CSF sample gave a non-specific reaction.

b

  One sample aseptic; E. coli isolated from other sample.



c

  Two additional blood culture supernatants gave non-specific reactions.

d

  One sample aseptic. Other samples grew: Staph. aureus; E. coli + Staph. 



epidermidis; K. oxytoca; alpha-haemolytic streptococcus.

table 4

results of clinical studies on Wellcogen

tM

 s. pneumoniae

 

Sensitivity Specificity



Sample 

No. tested  No. positive  No. tested  No. positive

CSF 

51  45 483



a

 2

b



Serum 

6  6 13 0

Urine 

105  46 320



c

 0

Blood Culture 



113 

109 


1512 

7

d



a

  One additional CSF gave a non-specific reaction.

b

  Enterobacter aerogenes; coliform bacterium.



c

  Three additional urine samples gave non-specific reactions.

d

 Pseudomonas; Strep. sanguis; Staph. epidermidis + Enterococcus; Strep. 



viridans isolated from 4 samples.

table 5

results of clinical studies on 

Wellcogen

tM

 N. meningitidis aCy W135

 

Sensitivity Specificity



Sample 

No. tested  No. positive  No. tested  No. positive

CSF 41

a

 29 423 2



b

Serum 


5  3 36 0

Urine 


0  – 229

c

 0



Blood Culture 



1615 

2

d



a

  Includes 8 group A, 25 group C and 1 group Y (the remainder were not 

grouped).

b

  K. aerogenes; E. coli.



c

  Five additional urine samples gave non-specific reactions.

d

  Strep. sanguis; Staph. epidermidis + Enterococcus.



table 6

results of clinical studies on 

Wellcogen

tM

 N. meningitidis B/E. coli K1

 

Sensitivity Specificity



Sample 

No. tested  No. positive  No. tested  No. positive

CSF 

N. meningitidis B 



11 

128 



0

E. coli K1

a

 

6  4 128 0



 

Serum: 


N. meningitidis B 



0

Urine: 



N. meningitidis B 



0

Blood Culture: 



N. meningitidis B 



461 

3

b



a

  Samples stored frozen. All other samples tested fresh.

b

  Aerobic and anaerobic cultures (beta-haemolytic strep A) for same patient



coagulase negative staphylococcus.

table 7

identification of cultures using 

Wellcogen

tM

 N. meningitidis B/E. coli K1

Culture


a

 

+ – 



N. meningitidis group A 

16



N. meningitidis group B 

10 


0

N. meningitidis group C 

18

N. meningitidis group 29E 



8

N. meningitidis group W135 



7

N. meningitidis group X 



4

N. meningitidis group Y 



5

N. meningitidis group Z 



3

E. coli K1 



0

E. coli – other antigens 



13

b



a

  Cultures identified by slide agglutination.

b

  An additional 10 cultures gave non-specific reactions.



14 BiBLiograPhy



argaman, M., Liu, t.y., et al (1974).

 

Polyribitol-phosphate: an antigen of four gram-positive bacteria cross-reactive 



with the capsular polysaccharide of Haemophilus influenzae type b.

 

J. Immunol., 112, 649.





Baker, C.J. and rench, M.a. (1983).

 

Commercial latex agglutination for detection of group B streptococcal antigen 



in body fluids.

 

J. Pediatr., 102, 393.





Bøvre, K., Bryn, K., et al (1983).

 

Surface polysaccharide of Moraxella non-liquefaciens identical to Neisseria 



meningitidis group B capsular polysaccharide. A chemical and immunological 

investigation.

 

NIPH Annals, 6, 65.





doskeland, s.o. and Berdal, B.P. (1980).

 

Bacterial antigen detection in body fluids: methods for rapid antigen concentration 



and reduction of nonspecific reactions.

 

J. Clin. Microbiol., 11, 380.





feigin, r.d., Wong, M., et al (1976).

 

Countercurrent immunoelectrophoresis of urine as well as of CSF and blood for 



diagnosis of bacterial meningitis.

 

J. Pediatr., 89, 773.





Kaldor, J., asznowicz, r., et al (1977).

 

Latex agglutination in diagnosis of bacterial infections, with special reference to 



patients with meningitis and septicemia.

 

Amer. J. Clin. Path., 68, 284.





Kasper, d.L., Winkelhake, J.L., et al (1973).

 

Immunochemical similarity between polysaccharide antigens of Escherichia coli 



07:K1(L):NM and group B Neisseria meningitidis.

 

J. Immunol., 110, 262.





Lee, C.J. and Koizumi, K. (1981).

 

Immunochemical relations between pneumococcal group 19 and Klebsiella 



capsular polysaccharides.

 

J. Immunol., 127, 1619.





robbins, J.B., Myerowitz, r.L., et al (1972).

 

Enteric bacteria cross-reactive with Neisseria meningitidis groups A and C and 



Diplococcus pneumoniae types I and III.

 

Infect. Immun., 6, 651.



10 

Whittle, h.C., tugwell, P., et al (1974).

 

Rapid bacteriological diagnosis of pyogenic meningitis by latex agglutination.



 Lancet, 

ii, 619.

Bronidox


®

 is the registered trade name of Cognis UK Ltd.

Minicon

®

 is a trade mark of the Millipore Corporation.



 

Manufactured by: 

Remel Europe Ltd 

Clipper Boulevard West, Crossways 

Dartford, Kent, DA2 6PT 

UK

IFU X7713B, Revised July 2014 



Printed in the UK

For technical assistance please contact your local distributor.




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