Verification of Performance of the FilmArray Meningitis/Encephalitis (ME) Panel

Transcription

1 For n-us Customers Only Verification of Performance of the FilmArray Meningitis/Encephalitis (ME) Panel Laboratory Guielines for Qnostics Materials Purpose This ocument provies examples of verification proceures to assist your laboratory in eveloping a protocol for performance verification of the FilmArray ME Panel on FilmArray Systems. The proceure can also be use for other applications at the laboratory irector s iscretion, e.g. lab personnel training, lotto-lot change testing, verification of loaner an repaire instruments. The Laboratory Director is ultimately responsible for ensuring that verification proceures meet the appropriate stanars for applicable laboratory accreiting agencies. In aition, testing patient samples for verification or to evaluate matrix effects on the performance of the FilmArray ME Panel shoul be one uner the guiance of the Laboratory Director, but is not escribe here. FilmArray Intene Use The FilmArray ME Panel is a qualitative multiplexe nucleic aci-base in vitro iagnostic test intene for use with FilmArray Systems. The FilmArray ME Panel is capable of simultaneous etection an ientification of multiple bacterial, viral, an yeast nucleic acis irectly from cerebrospinal flui (CSF) specimens obtaine via lumbar puncture from iniviuals with signs an/or symptoms of meningitis an/or encephalitis. The following organisms are ientifie using the FilmArray ME Panel: Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitiis (encapsulate), Streptococcus agalactiae, Streptococcus pneumoniae, cytomegalovirus, enterovirus, herpes simplex virus 1, herpes simplex virus 2, human herpesvirus 6, human parechovirus, varicella zoster virus, Cryptococcus neoformans/gattii. Refer to the FilmArray Meningitis/Encephalitis (ME) Panel Instruction Booklet for the complete intene use statement an aitional information about the use of the FilmArray System. 1 P a g e FLM1-PRT Technical te

2 Verification Proceure: Overview The verification proceures (i.e. simplifie an expane) have been esigne to take avantage of the multiplex nature of the FilmArray Meningitis/Encephalitis (ME) Panel. Verification testing efficiency is maximize by evaluating multiple target organisms in a single test run. The proceures were evelope using a panel available from Qnostics Lt., UK (Part number: MEEP01-C). This FilmArray ME Panel verification scheme generates positive an negative tests for each organism etecte by the FilmArray ME Panel. The proceures escribe below may be easily moifie or expane to meet specific criteria. A simplifie proceure for performance verification is escribe below. An expane proceure is also escribe in case the laboratory irector chooses to expan the verification protocol to cover more instruments, evaluate ay-to-ay an/or operator-to-operator variability. Both proceures are base on preparing 3 ifferent pools of organisms to cover all 14 analytes from the FilmArray ME Panel. The simplifie protocol will only require 3 pouches, the expane protocol will require 12 pouches (Table 1). Table 1. Overview of Expane an Simplifie Verification Protocols Numbe Replicate Expecte r of Protocol s per Sample Sample s per Pouches Require Expecte Negative Results Approximat e Days of Testing a Positive s Results 1 per 2 per Simplifie organism organism 4 or 5 3 Expane 4 per 8 per organism organism a The approximate number of ays for testing assumes a system configure with one or three instruments epening on the protocol consiere. Verification Proceure: Recommene Materials Table 2 lists materials recommene to perform verification proceures. Table 2. Recommene Materials for Protocols Material Part Number FilmArray ME Panel Kit (30 tests) Control Biohit mline Single Channel Manual Pipette µl Biofire Diagnostics, LLC RFIT-ASY-0118 Qnostics Lt, UK (a) ; MEEP01-C BioHit Part # (or equivalent) 1.5 ml Microfuge tubes Eppenorf, (European) a Any appropriate source of organism may be use for verification of any or all of the assays in the FilmArray ME Panel. However, when alternate organism sources are use, the sample volumes or pooling schemes suggeste in the examples below may nee to be ajuste. Verification Proceure: Simplifie Protocol The simplifie protocol tests a total of 3 pouches, proviing 1 positive result an 2 negative results per organism (Table 1). The number of samples teste per ay shoul be etermine by the iniviual laboratory. The recommene protocol requires the preparation of 3 organism pools for testing, each containing up to 5 ifferent control organisms (Qnostics Lt, MEEP01-C; see Table 3 for a etaile escription of each pool). 2 P a g e FLM1-PRT Technical te

3 The propose pooling scheme (Table 3), in line with Qnostics prouct format, i.e. 3 boxes of biological material, shoul be followe to obtain the expecte positive an negative results for each assay in a time an resource-efficient manner. te: Dilution of Qnostics ME Panel organisms beyon levels propose in these guielines may lea to inconsistent results an is not recommene. Table 3. Recommene ing Scheme POOL 1 Control Escherichia coli K1 Cytomegalovirus (CMV) Coxsackie B3 Streptococcus pneumoniae Human Herpesvirus 6 (HHV-6) Control Volume Approximate Final Volume of 1.25 ml POOL 2 Herpes simplex virus 1 (HSV-1) Neisseria meningitiis Streptococcus agalactiae Cryptococcus gattii POOL 3 Haemophilus influenzae Herpes simplex virus 2 (HSV-2) Varicella zoster virus (VZV) Listeria monocytogenes Human parechovirus (HPeV) 1.0 ml 1.25 ml Simplifie Protocol Example The estimate total time to completion for this verification example is 1 ay for systems configure with one instrument (Figure 1). Step 1 Prepare Prepare the three organism pools (e.g. pool 1-3) from Qnostics control material. te: It is important to prepare only the number of organism pools that will be teste within 2 ays of preparation. a. Transfer of the Qnostics organism to a tube large enough (at least 1.5 ml) to hol the entire organism pool volume. b. Repeat step a for each of the remaining organisms to combine the appropriate organisms for each pool into a single vial or tube (approximately ml total volume). Cap tube an vortex to mix well. te: The organism pool may be store refrigerate (2 8 C) for up to 2 ays. 3 P a g e FLM1-PRT Technical te

4 Step 2 FilmArray Testing a. Test 1 pouch from a single organism pool (e.g. pool 1). Refer to the FilmArray Meningitis/Encephalitis (ME) Panel Instruction Booklet or FilmArray Meningitis/Encephalitis Panel Quick Guie for pouch proceure etails. te: Use clean gloves an other Personal Protective Equipment (PPE) when hanling pouches an samples. Only prepare one FilmArray ME pouch at a time an change gloves between samples an pouches b. Repeat steps 1 an 2 for another organism pool (e.g. pool 2-3) to be teste that ay. Day Figure 1. Simplifie Protocol Workflow Verification Proceure: Expane Protocol The protocol escribe above can be expane to increase the number of tests for each of the organism pools an to inclue more variables (e.g. ay, operator, instruments). The protocol can be followe to test a total of 12 pouches, proviing 4 positive results an 8 negative results per organism (Table 1). Example of an avance verification protocol is provie below (Figure 2). Figure 2. Expane Protocol workflow (example). Expane Protocol Example The estimate total time to completion for this verification example is 2 ays for systems configure with at least 3 instruments (Figure 2). On ay 1, each Operator will test all 3 pools as escribe in the simplifie protocol. Testing is repeate on ay 2. The laboratory Director may choose to increase the number of operators, or in contrast limit the testing to one operator. 4 P a g e FLM1-PRT Technical te

5 Contact an Legal Information Customer an Technical Support Information Phone: Website: 5 P a g e FLM1-PRT Technical te

6 FilmArray Meningitis/Encephalitis (ME) Panel Verification Recor Computer System Serial #: FilmArray ME Panel kit Part #: Lot #: /sample Source an Lot #: Was the. Instrument... Days System # Positive Negative Users Detecte? Teste Escherichia coli K1 Cytomegalovirus (CMV) Enterovirus Streptococcus pneumoniae Human Herpesvirus 6 (HHV-6) Herpes simplex virus 1 (HSV-1) Neisseria meningitiis Streptococcus agalactiae Cryptococcus neoformans/ gattii Haemophilus influenzae Herpes simplex virus 2 (HSV-2) Varicella zoster virus (VZV) Listeria monocytogenes Human parechovirus (HPeV) Reviewe by: Signature Date 6 P a g e FLM1-PRT Technical te