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New Customer Onboarding Guide

Click HERE to download the Biomeme New Customer Onboarding Guide.


Biomeme Onboarding Outline: ‘Biomeme 101’ 

Customer Success Team: 

Andrew Barnard, Julia Baum, and Sarah Senula 

 

Contact: 

Email: support@biomeme.com  

Email is the best way to reach a Customer Success team member directly 

Phone: 267-930-7707 

FAX: 855-940-0157 

 

Description: 

Customer onboarding is a vital process that helps new customers learn a company’s product. Here at Biomeme, we take the onboarding process to heart and strive to offer a top-tier customer experience. During the onboarding process, you will have access to over 20 How-To videos, a personalized video onboarding call with our customer success team, and much more. Our goal is to ensure that every new customer gets the chance to participate in each carefully designed part of the onboarding process to ensure success with our product. 

 

 

General Objectives: 

  • Become familiar with your new Biomeme products, including but not limited to Go-Strips, M1 Sample Prep, and portable Franklin thermocycler 


  • Learn and utilize new or unfamiliar terms/vocabulary 


  • Be comfortable navigating our Help Desk, Biomeme Go App, and the Biomeme Cloud 


  • Become comfortable going through the end-to-end workflow 


  • Become confident in analyzing your results 

 

 

Expectations/Goals: 

  • Fill out the New Customer Onboarding Form (if applicable). This will help the customer success team personalize your onboarding call. We will send this to you if we need this information. 


  • Schedule and attend your onboarding call with the customer success team. We highly recommend all new customers participate in an onboarding call. We are flexible and can make almost anytime work with your schedule. Click here to schedule this call if you have not yet done so. 


  • Choose a Team Name and create user accounts for all members of your team. The customer success team will create these accounts for you. 


  • Watch all applicable How-To videos and explore FAQs on the Help Desk before your onboarding call. This will help give you more familiarity with our products. 


  • Download, install and log into the Biomeme Go App before your onboarding call. 


  • Communicate with the customer success team often, as we are here to help answer questions, troubleshoot problems, and be your number one contact after you receive your new Biomeme products. We like to hear when things are going well, too! 

 

 

Onboarding Video Call Agenda 

The onboarding call will be approximately 60-90 minutes long but can be shorter or longer to accommodate your needs. If there are any points that you would like to go over in more or less detail, do not hesitate to let the Customer Success team know before the onboarding call. During a typical call, expect to go over the following points/topics (for SARS-CoV-2 use cases): 

 

  • Welcome and Introductions - The Biomeme Customer Success team will introduce themselves, and the trainees will have the opportunity to do so as well. 


  • Laboratory and Background Information - If you have not yet filled out the New Customer Form (if applicable), this will be the time where the Customer Success team will ask the trainees about your lab background and experience. We will also ask about your goals with the product, i.e., runs per week, when you plan on starting, etc. 


  • Recommended Safety and Cleaning Points - We will review our recommendations regarding PPE and cleaning/disinfection during the end-to-end workflow. 


  • Materials - We will review the materials that you need to perform the end-to-end workflow. Make sure before the call you have the Biomeme Go App downloaded, installed, and logged in. 


  • Overview of Method - Quick review of what we will be going over in the following few steps. 


  • Resuspending RPC buffer - We will demonstrate how to resuspend the lyophilized RPC pellet (internal positive control). 


  • Sample Extraction using M1 Sample Prep - We will demonstrate how to use our M1 sample prep and syringes/barbed column tips to extract the nucleic acids into a purified sample ready for PCR. 


  • Filling Go-Strips - We will demonstrate how to fill the Go-Strips with the purified sample. 


  • Loading the Franklin Thermocycler - We will demonstrate how to load the Franklin. 


  • Biomeme Go App - We will show you how to Navigate the Biomeme Go App. 


  • Starting a Run - We will demonstrate how to start a run using the Biomeme Go App. 


  • Navigating Help Desk - If not already familiar with our Help Desk, we will show where all the useful things live. 


  • Results Interpretation - We will walk you through results interpretation on the Biomeme Go App. 


  • Biomeme Cloud - We will demonstrate how to navigate and see your results on the Cloud. We will show you specific examples of runs that you may encounter. 


  • Recommended Clean-up Procedure - We will briefly go over the clean-up procedure. 


  • Questions - This is the time where we will address any final questions that you may have. 

 

 

Materials Checklist 

SARS-CoV-2 Real-Time RT-PCR Test:  

Per one 9-well reaction 

 

Standard Lab Equipment: 

EQUIPMENT 

QTY 

PPE (gloves at minimum, goggles, face shield, lab coat) 

As needed 

Biohazard bags 

1x 

Ethanol (diluted to 70%) in a spray bottle for cleaning 

As needed 

Bleach for cleaning 

As needed 

Paper towels 

As needed 

 

For Collection: 

EQUIPMENT 

QTY 

Biomeme DNA/RNA Preservation Buffer or BD Universal Viral Collection Kit (Viral Transport Media) 

As needed 

DNA/RNA Preservation Buffer Tubes 

9x 

Collection Swabs 

9x 

Premeditated way of labeling vials, whether it is handwritten with a marker or given a barcode/QR code 

As needed 

 

For RPC resuspension: 

EQUIPMENT 

QTY 

RPC Kit Contents: RPC pellet, buffer, 1mL disposable pipette 

1x kit 

 

For Preparation: (get out as many as you will need before you start) 

EQUIPMENT 

QTY 

Sample prep tray 

1x 

Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0 

9x 

Syringes 

9x 

Barbed Column Tips 

9x 

Biomeme SARS-CoV-2 Go-Strips 

3x 

200µL Transfer Pipette 

9x 

Void filling cap strips 

3x 

Pink 20µL Fixed Volume Pipette 

1x 

Pipette tips 

18x 

2mL Self-Standing Tubes 

9x 

 

 

To Test and Analyze Sample: 

EQUIPMENT 

QTY 

Smart Phone 

1x 

Biomeme Go app and Login info 

N/A 

Biomeme Franklin three9 Real-Time PCR Thermocycler 

1x 

Biomeme Cloud 

N/A 

 

Optional: 

EQUIPMENT 

QTY 

Micropipette(s) 

As needed 

Vortex 

1x 

Positive Control (See IFU for our recommendations) 

1x 

Molecular Grade Water 

As needed 

 

 

Storage Requirements 

SARS-CoV-2 Real-Time RT-PCR Test 

SOURCE: REF# 

COMPONENT 

STORAGE REQUIREMENTS/SHELF LIFE 

200µL Transfer Pipette Pack 

Store in a dry place at room temperature (15-30°C). 

Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0 

Store in a dry place at room temperature (15-30°C)/ 1 year. 

20µL Fixed Volume Pipette 

Store in a dry place at room temperature (15-30°C).  

Pipette Tips 

Store in a dry place at room temperature (15-30°C). 

2mL Self-Standing Tubes Pack 

Store in a dry place at room temperature (15-30°C). 

Biomeme SARS-CoV-2 Go-Strips* 

If unopened, store in a dry place at room temperature (15-30°C)/1 year.

 

Remove as much air from the pouch as possible when re-sealing and ensure the zipper is fully closed. Always check the quality of reagents before use. 

Component of 3000555 

RNA Positive Control 

If unopened, store in a dry place at room temperature (15-30°C)/1 year. 

  

Once resuspended, RPC can be stored at room temperature (15-30°C) for a maximum of 2 days. For longer-term storage, it can be aliquoted and frozen at -20 °C for up to three months.  

Biomeme Franklin three9 Real-Time PCR Thermocycler 

Store in a dry place at room temperature (15-30°C). 

DNA/RNA Preservation Buffer Tubes 

Store in a dry place at room temperature (15-30°C)/1 year. 

N/A 

DNA/RNA Preservation Buffer Tubes with sample 

Store in a dry place at room temperature (15-30°C)/1 year 

N/A 

Purified Extracted 

Sample in Collection Tube 

Use purified patient samples as soon as possible after extraction. 

 

 

Cleaning and Decontamination Tips 

The environment is full of DNases and RNases, and other enzymes that degrade genetic material. When working with DNA and RNA, it is best to try and minimize the introduction of these enzymes into our samples, especially after they are purified. Further, limiting contamination across samples, which could potentially result in false positives, is very important. Below, good cleaning practices will be outlines to help avoid sample degradation and contamination.  Please also see page 12 in the IFU (Instructions for Use) for more information about minimizing the risks of contamination. 

 

During Sample Testing 

 

Always wear PPE (personal protective equipment) 

  1.  Gloves with adequate chemical resistance 

  1. Some components of the Biomeme SARS-CoV-2 test have irritative properties. Gloves protect your hands from such components 

  1. Gloves help prevent contamination from skin getting into your samples/RPC 

  1.  Gloves should be changed or sprayed with 70% ethanol between processing each sample 

 

  1.  Goggles/Face shield 

  1.  Goggles help protect your eyes from exposure to hazardous or infectious materials during sample collection or processing 

 

  1. Lab coat 

  1. Lab coats help protect your skin and clothing from hazardous or infectious materials 

 

RPC Aliquoting 

  1. Regardless of lab throughput, we highly recommend aliquoting and freezing RPC to prevent contamination of the entire tube 

 

  1. If there is a contamination event that may have compromised the RPC, the aliquot used that day should be disposed of, and after a deep clean, another aliquot can be thawed and used 

 

Do Not Place Hand -- Whether Gloved or Not -- Inside of Pouches/Bags (Go-Strips, Cartridges, Pipettes, etc.) 

  1. It is standard practice to shake out needed contents out of a bag, opposed to putting hands inside of a bag, even with a clean glove on 

 

  1. Before doing any sample processing, take out the materials needed and place in clean sample tray 

 

Biohazard Waste Bag/Bin 

  1. Always dispose of potentially biohazardous solutions according to your local, regional, or national waste disposal guidelines 

 

  1. Keep a biohazard bin/bag within reach to dispose of used pipette tips, M1 cartridges, syringes, barbed column tips, used Go-strips/void caps, etc. 

 

  1. Be mindful of your specific workplace and whether or not you need to use a sharps container 

 

Keep Lids on Everything 

  1. When not in use, keep caps/lids on all vials and tubes 

 

  1. If cap/lid must be placed down, make sure to put it on a clean working surface (such as the sample prep tray cover or KimWipe) with the inside facing down on the clean working 

 

Cleaning Workspace 

  1. DO NOT add bleach or acidic solutions directly to the liquids contained in Biomeme’s M1 Sample Prep cartridges 

  1. The BLB (Biomeme Lysis Buffers) and BPW (Biomeme Protein Wash) buffers can form highly reactive compounds when combined with sodium hypochlorite (a.k.a. liquid bleach) 

  1. If a spilled liquid contains potentially infectious agents, clean the affected area multiple times with laboratory detergent and water. Then, clean the area with 1% (v/v) sodium hypochlorite 

 

  1. If liquid containing these buffers is spilled, clean with suitable laboratory detergent, like CaviCide and water, or 70% alcohol 

 

 

Before and After Runs are Completed 

 

Wash Hands 

  1. Wash hands thoroughly with soap and warm water before and after handling samples, prep tools, equipment, etc. 

 

Clean All Work Surfaces Thoroughly 

  1. It is a good rule of thumb to always clean before and after doing molecular work to best mitigate the risks of contamination 

 

  1. Before working, spray a paper towel with freshly made 10% bleach, then wipe down the work surface, then wipe up residue with ethanol (70%) 

 

  1. After working, wipe down with ethanol, then with 10% bleach, sprayed on a paper towel first, then the work surfaces 

 

Use Bleach to Clean (10% sodium hypochlorite) 

  1. Use only before or after you are done running samples, sprayed onto a paper towel first 

 

  1. Clean everything with this, aside from reusable pink fixed volume pipette, outside of the RPC vial, and scissors/blade used to cut Go-Strips/Void filling caps 

 

  1. Bleach degrades any nucleic acid that is present and is the best way to clean/decontaminate 

 

  1. Bleach can degrade RPC or kill the reaction if any residue gets into Go-Strips 

 

  1. DO NOT make direct contact with bleach and buffers from M1 Sample prep or preservation tubes 

 

Ethanol (70%) 

  1. Always go over anything you cleaned with bleach with ethanol or to wipe up excess residue 

 

 

Folder & Run Organization/Naming Runs 

Folder and run organization depend on lab throughput. Below we will outline best practices for effective management of folder and run organization for each throughput level. We will also review the best methods of naming runs. 

 

Low Throughput Lab: fewer than 250 samples per week 

  1. If you are performing fewer than 250 samples or ~28 runs per week, putting all runs in one folder per month will work fine 

  1. For example:  

  1. 2021 → 03 - March → *save runs here* 

  1. 2021 → 04 - April    → *save runs here* 

 

High Throughput Lab: more than 250 samples per week 

  1. If you are performing more than 250 or ~28 runs per week, we recommend organizing runs by Month → Week of X-X 

  1. For example: 

  1. 2021 → 03 - March → Week of 3-1   → *save runs here* 

  1. 2021 → 03 - March → Week of 3-8   → *save runs here* 

  1. 2021 → 04 - April    → Week of 4-5   → *save runs here* 

  1. 2021 → 04 - April    → Week of 4-12 → *save runs here* 

 

Naming Runs 

  1. In the Biomeme Go App, right after you choose where to save the run, the app will prompt you with “Run Setup” 

  1. This step will include “Run Name,” “Parent Folder,” and “GPS Coordinates.” 

 

  1.  In this step, keep the run name exactly as it automatically generates. 

  1. The automatically generated name will be in the format of “2021-03-22-16130441” 

  1. If desired, initials of who is running the samples can be added onto the end of the automatically generated name, as this will help keep track of who runs which samples on any given day if there are multiple users. 

  1. For example:  

  1. “2021-03-22-16130441SS” 

 

Some More Helpful Tips 

  1. If you plan to use “Month” as a folder, always name it by the month order and then the date, 

  1. For example:  

  1. “01 - January”, “07 - July”, “12 - December” 

  1. This will keep the folders ordered chronologically, opposed to alphabetically  

  1. There are many ways to name/organize folders besides the ones that we have outlined above 

  1. One thing that we always recommend is to create your organization plan before you ever start to perform tests on your Franklin Thermocycler 

 

Note: At this time, once a folder is created, it is not able to be moved or renamed. We are unable to move a run between folders. 

 

  1. Importantly, whichever naming schema you choose, try to keep everything as consistent as possible 

 

 

 

Glossary: Commonly Used Terms and Abbreviations 

 

ACRONYM 

DEFINITION 

BDW 

Biomeme Drying Wash 

BEB 

Biomeme Elution Buffer 

BLB 

Biomeme Lysis Buffer 

BPW 

Biomeme Protein Wash 

BWB 

Biomeme Wash Buffer 

cDNA 

complementary Deoxyribonucleic Acid 

CDC 

Centers for Disease Control and Prevention 

CLIA 

Clinical Laboratory Improvement Amendments of 1998 

COVID-19 

Coronavirus Disease of 2019 

DNA 

Deoxyribonucleic Acid 

EUA 

Emergency Use Authorization 

FDA 

Food and Drug Administration 

IFU 

Instructions For Use 

IPC 

Internal Positive Control 

IVD 

IVitro Diagnostics 

LOD 

Limit ODetection 

NTC 

NTemplate Control 

Orf1ab 

Open Reading Frame 1ab 

PCR 

Polymerase Chain Reaction 

qPCR 

quantitative (or semi-quantitative) Polymerase Chain Reaction 

PPE 

Personal Protective Equipment 

RFU 

Relative Fluorescence Units 

RNA 

Ribonucleic Acid 

RPC 

RNA Process Control 

RT-PCR 

Reverse Transcriptase Polymerase Chain Reaction 

RUO 

Research Use Only 

SARS-CoV-2 

Severe Acute Respiratory Syndrome Coronavirus 2 

SDS 

Safety Data Sheets 

VTM 

Viral Transport Media 

 

PRODUCT 

PURPOSE 

MFG. BY BIOMEME? 

200uL Transfer Pipettes 

Used to transfer 200uL of patient sample into the first chamber of the M1 Sample Prep Cartridge 

No 

2mL Sample Collection Tubes 

Screw-cap tubes with many uses; commonly used for collecting the extracted sample after performing M1 Sample Prep or holding aliquots of other solutions such as processed positive control. Preferred over tubes with flip-cap for long-term storage 

No 

Android Smartphone 

OR 

Rugged CAT Phone 

Standard Android smartphone with the Biomeme Go app pre-installed, included as a required product in the EUA for SARS test. 

Rugged CAT phone also has the Biomeme Go app pre-installed and is more durable than the standard android smartphone. 

No 

Barb Column Tips 

Tips compatible with Luer-Lock syringes sold/used with M1 Sample Prep Cartridges. These tips contain a silica membrane (called a filter) that captures the target DNA/RNA from the sample during the sample prep. 

YES 

Barrier Pipette Tips 

Disposable pipette tips that come in varying sizes to accommodate the various sizes of pipettes and contain a filter that acts as a barrier between the part of the tip that will hold the liquid, and the pipette itself. These are preferred because they lessen the risk of pipette contamination. 

No 

BDW 

(Biomeme Drying Wash) 

Biomeme Drying Wash is found in the 4th chamber of the M1 Sample Prep cartridge. It prepares the filter for efficient drying in the Air-Dry Step that follows.  

YES 

BEB 

(Biomeme Elution Buffer) 

Biomeme Elution Buffer is found in the 6th and final chamber of the M1 Sample Prep cartridge. This solution will cause the DNA/RNA to be released from the filter, into this solution, which then becomes the extracted sample. This solution is not designed to stabilize the DNA/RNA for long, and the extracted sample must be used within 4 hours maximum since the sample preparation. 

YES 

BLB 

(Biomeme Lysis Buffer) 

Biomeme Lysis Buffer is found in the 1st chamber of the M1 Sample Prep, or in Biomeme’s VTM which is called DNA/RNA Preservation Buffer.  This buffer lyses cells and breaks open viral capsids to release the DNA/RNA into solution and inactivates the SARS-CoV-2 virus after 10 minutes of incubation, significantly lowering the risk of working with a potentially hazardous sample. 

YES 

BPW 

(Biomeme Protein Wash) 

Biomeme Protein Wash is found in the 2nd chamber of the M1 Sample Prep cartridge and causes unwanted proteins to unbind from the filter, increasing the purity of the extracted sample. 

YES 

BWB 

(Biomeme Washing Buffer) 

Biomeme Wash Buffer is found in the 3rd chamber of the M1 Sample Prep cartridge and causes other potential contaminants to unbind from the filter, increasing the purity of the extracted sample. 

YES 

Bulk Vial 

These contain the same lyophilized assay that is found in the Go-Strips or Go-Plates, but in bulk. A bulk vial is one time use, because once it is resuspended, it has a short shelf life. One bulk vial is enough for about 165 reactions, but this number may vary depending on the final concentration desired. 

YES 

Centrifuge 

A machine that generates centrifugal force, which at low speeds for short amounts of time (<4 seconds), can gently pull any droplets on the inside of the tube to the bottom, without causing separation of the homogenous solution. When working with microliter volumes, a small droplet remaining separate from the rest of the sample can significantly alter the concentration of the sample and therefore impact the test result. 

No 

Fixed-Volume Pipette (10uL) 

Reusable pipette used to transfer 10uL volumes, required for processing positive control samples.  

No 

Fixed-Volume Pipette (20uL) 

Reusable pipette used to transfer 20uL volumes, required for transferring purified/extracted sample into Go-Strip wells. 

No 

Flocked Specimen Collection Swabs 

Used to collect nasopharyngeal or nasal swab specimens. 

No 

Franklin one9 Thermocycler 

Portable, hand-held, battery-operated thermocycler. The Franklin one9 has 1 active color channel (FAM probe - green) and 9 reaction wells. The other two color channels can be activated by using an upgrade code, since all Franklins are inherently capable of detecting all three color channels. The thermocycler can cycle through temperatures as low as 40°C and as high as 100°C.  

YES