PRAXISDIENST 920006N-10 NADAL Norovirus GI-GII Test Instruction Manual

NADAL® Norovirus GI/GII Test
(test cassette)
REF 920006N-10

Instructions for use

920006N-10 NADAL Norovirus GI-GII Test

nal von minden GmbH
Carl-Zeiss-Strasse 12
47445 Moers
Germany
Moers
Tel: +49 (2841) 99820-0
Fax: +49 (2841) 99820-1
Regensburg
Tel: +49 941 29010-0
Fax: +49 941 29010-50
www.nal-vonminden.com
info@nal-vonminden.com
Directors: Commercial reg. Kleve
Sandra von Minden: HRB 5679
Roland Meißner: Steuer-Nr. 244/133/00130
Thomas Zander: UST-ID-Nr. DE 189 016 086

Intended Use

The NADAL® Norovirus GI/GII Test is a rapid chromatographic immunoassay for the qualitative detection and differentiation of norovirus antigens of genogroups I and II (GI und GII) in human faecal specimens. The test is intended for use as an aid in the diagnosis of norovirus infection and is designed for professional use only.

Introduction and Clinical Significance

Noroviruses, members of the Caliciviridae family, are a group of more than 40 extremely heterogeneous viruses. Infection is typically characterised by self- limiting vomiting and diarrhoea, with symptoms prevailing for 12-60 hours. Patients may remain contagious even after their diarrhoea has cleared up.
Norovirus is a leading cause of gastroenteritis among adults in America, causing more than 90% of outbreaks. These localised epidemics typically occur when groups of people spend time in close physical proximity to each other, such as on cruise ships, in hospitals or in restaurants. Noroviruses commonly isolated in cases of acute  gastroenteritis belong to two genogroups: GI and GII.

Test Principle

The NADAL® Norovirus GI/GII Test enables the detection of norovirus antigens of genogroups I and II through the visual interpretation of colour development on the internal test strip. Antibodies to noroviruses GI and GII are immobilised in the test line region (GI) and (GII) of the membrane. A faecal sample is added to a specimen collection tube containing buffer in order to release norovirus antigens of genogroups I and II. During the test, extracted antigens bind to antibodies to noroviruses GI and GII, which are conjugated to coloured particles and precoated onto the sample pad of the test cassette. The mixture then migrates along the membrane by capillary action and interacts with the reagents on the membrane. The complexes are then captured by antibodies to noroviruses GI and GII in the test line region (GI) and (GII). Excess coloured particles are captured in the control line region (C).
The presence of a red line in the test line region (GI) and/or (GII) indicates a positive result for particular viral antigens, whereas its absence indicates a negative result. The formation of a green line in the control line region (C) serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Reagents and Materials Supplied

• 10 NADAL® Norovirus GI/GII test cassettes (incl. disposable pipettes for liquid faecal samples)
• 10 specimen collection tubes with buffer
• 1 package insert

Additional Materials Required

• Specimen collection containers
• Disposable gloves
• Timer

Storage & Stability

NADAL® Norovirus GI/GII test kits should be stored at 2-30°C and used by the expiry date indicated on the packaging. Test cassettes should remain in the sealed pouches until use. Do not freeze test kits. Do not use tests beyond the expiry date. Care should be taken to protect components of the test kit from contamination. Do not use the test if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

Warnings and Precautions

• For professional in-vitro diagnostic use only.

• Carefully read through the test procedure prior to testing.

• Do not use the test beyond the expiration date indicated on the packaging.

• Do not use the test if the foil pouch is damaged.

• Do not reuse tests.

• Do not add samples to the reaction area (result area).

• In order to avoid contamination, do not touch the reaction area (result area).

• Avoid cross-contamination of specimens by using a new specimen collection tube for each specimen obtained.

• Do not substitute or mix components from different test kits.

• Do not use the buffer if it is discoloured or turbid.
  Discolouration or turbidity may be a sign of microbial contamination.

• Failure to bring specimens and reagents to room temperature prior to testing may decrease assay sensitivity. Inaccurate or inappropriate specimen collection, storage, and transport may yield false negative test results.

• Do not eat, drink or smoke in the area where specimens and test kits are handled.

• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are being assayed.

• Handle all specimens as if they contain infectious agents. Observe established precautions for microbiological risks throughout all procedures as well as standard  guidelines for the appropriate disposal of specimens.

• The test kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore recommended that these products be treated as potentially infectious, and handled in accordance with usual safety precautions (e.g., do not ingest or inhale).

• Humidity and temperature can adversely affect test results.

• Used testing materials should be disposed of in accordance with local regulations.

Specimen Collection and Preparation

Specimen Collection and Storage:
Use clean, dry specimen collection containers for specimen collection. The best results will be obtained if the assay is performed within 2 hours after specimen collection.
Note: Specimens collected in the specimen collection container may be stored at 2-8°C for up to 1-2 days, or at -20°C for up to 3 months if they are not to be tested within 2
hours of preparation.

If specimens are to be shipped, they should be packed in compliance with all applicable regulations for the transportation of etiologic agents.

Specimen preparation:
Use a separate specimen collection tube with buffer for each sample.
Hold the specimen collection tube upright and remove the applicator stick by unscrewing the light-blue cap. Be careful not to spill or splash buffer solution from the  collection tube.

For solid specimens:
Collect approx. 50 mg of faeces (equivalent to ¼ of a pea) by inserting the applicator stick in at least 3 different sites of the faecal specimen.

For liquid specimens:
Holding a pipette vertically, collect a faecal specimen and add 2 drops (approx. 80 µL) to the specimen collection tube containing buffer.
Place the applicator stick, along with the faecal specimen (or without the faecal specimen if the specimen is liquid), back into the specimen collection tube and tightly screw the cap closed.

Shake the specimen collection tube to thoroughly mix the specimen and buffer. Specimens prepared in the specimen collection tubes with buffer can be stored at -20°C for up to 6 months if they are not to be tested within 1 hour after preparation.

Test Procedure

Bring tests and samples with buffer to room temperature (15-30°C) prior to testing. Do not open the foil pouch until you are ready to perform the assay.

1. Remove the NADAL® Norovirus GI/GII test cassette from the sealed foil pouch and use it as soon as possible. Label the test cassette with the patient or control identification. For best results, the assay should be performed within 2 hours.

2. Shake the specimen collection tube to ensure good sample dispersion. Unscrew the white cap and break off the tip of the tube using a piece of tissue. Holding the  specimen collection tube vertically, dispense 2 drops of solution into the sample well (S) of the test cassette. Avoid trapping air bubbles in the sample well (S) and do not add any solution to the result area.

3. Start the timer.
   Note: If the specimen does not migrate due to the presence of particles, centrifuge the specimen contained in the specimen collection tube. Collect 80 µL of supernatant, dispense it into the specimen well (S) of a new test cassette and, following the instructions stated above, start the test again.

4. Wait for the coloured line(s) to appear. Read the test result after 10 minutes. Do not interpret the result after more than 20 minutes.

Result Interpretation

Positive for norovirus genogroup I (GI) One green line develops in the control line region (C) and one red line develops in the test line region (GI) for norovirus GI.

Positive for norovirus genogroup II (GII)
One green line develops in the control line region (C) and one red line develops in the test line region (GII) for norovirus GII.

Positive for norovirus genogroup I and II (GI and GII)
In addition to the green control line (C), a red line develops in each test line region: (GI) for norovirus GI and (GII) for norovirus GII.

Negative
One green line develops in the control line region (C). No line develops in either test line region (GI) or (GII).

Invalid
The green control line (C) fails to appear. Results from any test which has not produced a control line at the specified reading time must be discarded.

Please review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your distributor.
Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for the control line failure.

Quality Control

An internal procedural control is included in the test cassette:
A green line appearing in the control line region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
Good laboratory practice (GLP) recommends the use of external control materials to ensure proper test kit performance.

Limitations

• The NADAL® Norovirus GI/GII Test is for professional in-vitro diagnostic use only and should only be used for the qualitative detection of noroviruses GI and GII. The colour intensity of the test lines (GI) and (GII) cannot be used for semiquantitative or quantitative evaluation.

• As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and
  laboratory findings have been evaluated.

• The sections ‘Test Procedure’ and ‘Result Interpretation’ must be followed closely while testing. Failure to follow the procedure may lead to inaccurate test results.

• If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of a norovirus infection, as the concentration of viral particles may be below the detection level of the test.

• In case of a high-dose hook effect, the colour intensity of the test line decreases as the antigen concentration increases. If a hook effect is suspected, diluting specimens may increase the colour intensity of the test line.

• In order to prevent pseudo-outbreaks, positive test results in newborns must be confirmed using an alternative testing method (PCR).

• If visible blood is present in faecal specimens, false-positive results cannot be ruled out and must therefore be verified using an alternative test method.

Performance Characteristics

Clinical Performance
A total of 398 faecal samples were tested using the NADAL® Norovirus GI/GII Test and a commercially available immunochromatographic test for the detection of  norovirus antigens of genogroups I and II. The results are presented in the following table:

Relative sensitivity: 97.9% (94.1% – 99.3%)
Relative specificity: 99.6% (97.8% – 99.9%)
Overall agreement: 99.0% (97.4% – 99.6%)
95% Confidence interval

Cross-reactivity:
Cross-reactivity with the following organisms was studied at a concentration of 1 x 109 organisms/mL. Faecal samples containing the following organisms were found to be negative when tested using the NADAL® Norovirus GI/GII Test.

References

1. Eckardt AJ, Baumgart DC (January 2011). “Viral gastroenteritis in adults”. Recent Patents on Anti-infective Drug Discovery. 6 (1): 54–63.
2. Kissmann j., et al. “Physical stabilization of Norwalk Virus-like Particles”. Journal of Pharmaceutilca Sciences, VOL.97, NO. 10, OCTOBER 2008.
3. Lobuea A., et al. “Multivalent norovirus vaccines induce strong mucosal and systemic blocking antibodies against multiple strains”. Vaccine 24 (2006) 5220– 5234.
4. Kohler H, Jungert J, Korn K. Norovirus pseudo-outbreak in a neonatal intensive care unit. J Pediatr Gastroenterol Nutr 2008; 46(4):471-472.

Rev. 1, 2019-05-17 OM/SDe

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nal von minden GmbH
Carl-Zeiss-Strasse 12 • 47445 Moers • Germany
www.nal-vonminden.com
• info@nal-vonminden.com
Fon: +49 2841 99820-0
• Fax: +49 2841 99820-1

References

• nal von minden GmbH - Spezialist für hochwertige in-vitro Diagnostik
• nal von minden GmbH - Spezialist für hochwertige in-vitro Diagnostik

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