Product Manual

ManualsBrandsSekisui Diagnostics ManualsRapid TestsOsom® Ultra Flu A&B Nasal Pharyngeal Wash / Aspirate Kit - 50/bx

Ultra FLU A&B Test

Rev P-52631, 04/15

1. Tear the tab off the

Extraction Reagent Capsule.

Influenza

2. Squeeze the Extraction Reagent

capsule to dispense all of the

solution into the Extraction Well

of the test device.

Influenza

Date

______

________

4. Incubate 1 minute with

the swab in Extraction Well.

______

________

5. Hold the device with one

hand and the swab with

the other. While pressing

down on the swab, rotate

it in one direction 3 times to

mix the specimen. Remove

and discard the swab.

6. Raise the device upright (see picture).

Tap

7. Let it stand for 1–2 seconds. Gently tap

the device on a ﬂat surface to ensure

that the liquid ﬂows into the hole.

SWAB SAMPLE PROCEDURE

Slowly

8. Immediately after tapping, slowly lay

the device back down onto the ﬂat

surface.

9. Start timing. Read test results at 10-15

minutes. Conﬁrm negative results at

15 minutes.

Influenza

Date

Extraction Well

Result Window

Swab Stand

Test Device

3. Place the specimen swab on the Swab

Stand in the Extraction Well. Hold the

device with one hand and the swab with

the other. While pressing down on the swab,

rotate it completely in one direction 3 times

to mix the specimen.

______

________

Summary of content (14 pages)

PAGE 1
Result Window Extraction Well Swab Stand Date ID C B A Inf lu Date enz ____ a ID__ __ ____ __ C B A Influenza Inf Date en _ z ID_______ a ___ ___ B A C Infl D ue ate_ ID_______ a ____ __ nz B A C 4. Incubate 1 minute with the swab in Extraction Well. lu 2. Squeeze the Extraction Reagent capsule to dispense all of the solution into the Extraction Well of the test device. B A 6. Raise the device upright (see picture). 5. Hold the device with one hand and the swab with the other.
PAGE 2
lu A B C 7. Raise the test device upright (see picture). Date enz _ a ID_______ ___ ___ 8. Let it stand for 1-2 seconds. Tap the device on a flat surface to ensure that the liquid flows into the hole. Tap 9. Immediately after tapping, slowly lay the device back down onto the flat surface. Slowly C 10. Start timing. Read test results at 10-15 minutes. Confirm negative results at 15 minutes. 5. Dispense all of the solution in the transfer pipette into the Extraction Well of the test device. B 4.
PAGE 3
® Ultra FLU A&B Test CLIA Complexity: Moderate FOR LABORATORY AND PROFESSIONAL USE ONLY INTENDED USE OSOM Ultra Flu A & B Test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.
PAGE 4
REAGENTS AND MATERIALS PROVIDED Each OSOM Ultra Flu A & B Test kit contains enough reagents and materials for 25 tests. The following components are included in a kit. • 25 OSOM Ultra Flu A & B Test devices: The test strip in each device contains mouse monoclonal antibodies to nucleoprotein (NP) of influenza A and influenza B. The device is individually pouched. • 25 Extraction Reagent in capsules: For use with swab samples, 300 μL of Phosphate buffer with detergents and preservative.
PAGE 5
• If transport of the samples is required, the following transport media have been tested and shown not to interfere with the performance of the test. BDTM Universal Viral Transport medium Saline solution BDTM Eswab collection kit Veal Infusion Broth Puritan Amies Transport medium Puritan UTM medium Hank’s Balanced Salt Solution Copan UTM-RT medium Bartel ViraTransTM medium Tryptose Phosphate Broth PBS PBS + 0.
PAGE 6
TEST PROCEDURE Procedural Notes • The test procedure provided must be followed to obtain accurate and reproducible results. • Reagents, specimens, and devices must be at room temperature (18–30°C) for testing. • Do not open the foil pouch until you are ready to perform the test. • Several tests may be run at one time. • Label the device with the patient identification or control to be tested. • Place test device on a level surface.
PAGE 7
INTERPRETATION OF RESULTS Positive A reddish purple Control line (C position) and a reddish purple Test line (A or B position) indicate that Influenza A or B antigen has been detected. Lines at the A and C positions indicate the presence of Influenza type A viral antigen, and lines at the B and C positions indicate the presence of Influenza type B viral antigen in the specimen. A positive result does not rule out co-infections with other pathogens or identify any specific influenza A virus subtype.
PAGE 8
External Quality Control Good laboratory practice includes the use of external controls to ensure proper kit performance. It is recommended that external control testing be performed with each new operator and before using a new lot or shipment of OSOM Ultra Flu A & B kits to confirm the expected Q.C. results, using the external controls provided in the kit. The frequency of additional Q.C. tests should be determined according to your laboratory’s standard Q.C.
PAGE 9
Nasopharyngeal Swab Sample REFERENCE (VIRUS CULTURE) RESULTS OSOM Ultra Flu A & B Flu A Positive Flu A Negative Total Performance Flu A Positive 26 51* 77 Sensitivity 89.6% 95% CI: 84.095.2% Flu A Negative 3** 171 174 Specificity 77.0% 95% CI: 74.279.
PAGE 10
As further verification of the PCR test results shown from the samples with discrepant results between OSOM Utra Flu A&B and viral culture, available archived remnant samples from the clinical studies with concordant results were also tested by PCR. The PCR was performed on 138 Flu A negative and 27 Flu A positive samples with OSOM Ultra FLU A&B and culture, and 154 Flu B negative and 11 Flu B positive samples with OSOM Ultra Flu A&B and Culture.
PAGE 11
using the coded samples following the test protocol given in the package insert as if they are testing patient sample including the sample extraction step. The results obtained at each site agreed 100% with the expected results. No differences were observed within run (15 replicates), between runs (five different days), or between sites (two POL sites and one lab).
PAGE 12
Influenza Type Viral Strain EID 50/ML A A/Anhui/1/2013 (H7N9)** 7.94 x 10 6 A A/Vietnam/1194/2004(H5N1)** 1.6 x 10 6 A A/Anhui/01/2005 (H5N1)** 1.6 x 107 *Clinical isolate cultured and titered. Culture confirmed positive for 2009 H1N1 Influenza A strain using proFLU Influenza A Subtyping.
PAGE 13
Neisseria meningitides Neisseria sp. Pseudomonas aeruginosa Staphylococcus aureus: Protein A Producer Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus pyogenes Streptococcus salivarius Interference The interference study was conducted using medically relevant concentrations of the potentially interfering substances listed below with two strains each of influenza type A and type B to assess the potential interference of the substances on the performance of the OSOM Ultra Flu A & B Test.
PAGE 14
REFERENCES 1. Shaw MW, Arden NH and Massab HF. New aspects of influenza viruses. Clin. Microbiol. Rev. 5: 74-92 (1992) 2. WHO recommendations on the use of rapid testing for influenza diagnosis, July 2005. ASSISTANCE For assistance, call Sekisui Diagnostics Technical Service at 800-332-1042. RE-ORDER 1006 (QTY 25) Test Kit OSOM ® and the QC Inside logo are registered U.S. trademarks of Sekisui Diagnostics, LLC Princeton BioMeditech Corporation 4242 U.S. Hwy 1, Monmouth Jct. New Jersey 08852, U.S.A.