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New Customer Onboarding Guide

To download the PDF version of this guide, click HERE


Biomeme Onboarding Outline: ‘Biomeme 101’ 

Customer Success Team: 

Andrew Barnard, Kanak Gupta, Julia Baum, and Sarah Senula 

 

Contact: 

Email: support@biomeme.com 

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: 

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

 

  1. Learn and utilize new or unfamiliar terms/vocabulary 

 

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

 

  1. Become comfortable going through the end-to-end workflow 

 

  1. Become confident in analyzing your results 

 

Expectations/Goals: 

  1. 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 

 

  1. 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. 

 

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

 

  1. 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. 

 

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

 

  1. 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) 

 

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

 

  1. 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. 

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

 

  1. 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. 

 

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

 

  1. Resuspending RPC buffer - We will demonstrate how to resuspend the lyophilized RPC pellet (internal positive control), if applicable. 

 

  1. 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. 

 

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

 

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

 

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

 

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

 

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

 

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

 

  1. 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. 

 

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

 

  1. 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 

Preservation Buffer or another 3rd party VTM (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). High throughput labs should replace pipette after 2,500 uses or when wear becomes evident on pipette. 

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. 

  

Once the foil pouch is opened, strips should be used within 7-10 days. All air should be squeezed out of the pouch prior to reclosing. 

  

Individual test strips should be used within a reasonable period after removal from the  individual foil pouch. Once opened, the dry reagent resists high humidity for up to one hour. Do not remove foil until ready to load 

Component of 3000555 

RNA Positive Control 

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

  

Once resuspended, the RPC can be kept at room temperature (20-25°C) for 7-10 days. It can also be aliquoted and frozen at -20 °C for longer-term storage. We caution against frequent freezing and re-thawing as it will degrade the control. 

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)/ up to 9 months. 

N/A 

Purified Extracted 

Sample in Collection Tube 

If not being used within 15 minutes of extraction, store on ice for up to 4 hours. 

 

 

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, we want to minimize the introduction of these enzymes into our samples, especially after they are purified. Further, we want to limit contamination across samples, which could potentially result in false positives. Below, we will outline good cleaning practices 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 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 can 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 folder and run organization for each throughput level, as large numbers of runs in a single folder can cause performance issues. 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 

 

Acronyms 

 

TERM 

DEFINITION 

BDW 

Biomeme Drying Wash 

BEB 

Biomeme Elution Buffer 

BLB 

Biomeme Lysis Buffer 

BPW 

Biomeme Protein Wash 

BWB 

Biomeme Wash Buffer 

CDC 

 

Centers for Disease Control and Prevention 

CLIA 

Clinical Laboratory Improvement Amendments of 1998. Our IVD testing is limited to CLIA certified laboratories that can perform high complexity tests 

DNA 

Deoxyribonucleic Acid 

EUA 

Emergency Use Authorization 

FDA 

Food and Drug Administration 

 

IFU 

Instructions for Use; where you can find the most comprehensive directions for our SARS-CoV-2 testing 

IPC 

Internal Positive Control 

IVD 

In Vitro Diagnostics; used in human diagnostics, 'In Vitro" means outside of the body 

LOD 

Limit of Detection; this defines the minimum amount of nucleic acid that must be present in the sample for our test to be able to detect it 

NTC 

No Template Control; used to monitor reagent and/or environmental contamination. The expected Cq value is 0 

PCR 

Polymerase Chain Reaction- a method widely used to rapidly make millions of copies of a specific genetic sample (DNA or RNA) from as little as a few strands 

PPE 

Personal Protective Equipment 

RFU 

Relative Fluorescence Units; this is shown on the Y-axis of the results graph in the Biomeme Go App and Cloud 

RNA 

Ribonucleic Acid 

RPC 

RNA Process Control; a MS2 Bacteriophage (aka Amber, Internal Process Control, Internal Positive Control). RPC is represented in results as the Amber fluorescent color channel/curve 

RT-PCR 

In this type of PCR reaction, Reverse Transcriptase, an enzyme used to initiate reverse transcription, generates complementary DNA from an RNA template 

RUO 

Research Use Only 

SARS-CoV-2 

Severe Acute Respiratory Syndrome Coronavirus 2 is the full name of the virus, and the disease this virus causes is Covid-19 

SDS 

Safety Data Sheets 

VTM 

Viral Transport Medium; the Preservation Buffer by Biomeme is a type of this 

 

 

Materials/Products 

 

TERM 

DEFINITION 

200uL Transfer Pipettes 

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

2mL Sample Collection Tubes 

Versatile tubes commonly used for collecting the extracted sample after performing M1 Sample Prep, or holding aliquots of other solutions 

Android Smartphone 

Standard Android smartphone with the Biomeme app pre-installed. Used as the controller for the Franklin thermocycler 

Barbed Column Tips 

In-house manufactured, twist-on tips compatible with luer lock syringes. Contains filter/silica membrane to bind DNA/RNA 

BDW 

Biomeme Drying Wash is an alcohol wash found in the fourth chamber of the M1 Sample Prep cartridge that prepares the silica membrane in the Barbed Column Tip for the air dry step 

BEB 

Biomeme Elution Buffer found in the last chamber of the M1 Sample Prep cartridge. The pure RNA is released from the silica membrane into the solution/extracted sample 

BLB 

Biomeme Lysis Buffer found in the first chamber of the M1 Sample Prep. Lyses cells inactivate the virus. RNA binds to the filter/silica membrane in the Barbed Column Tip 

BPW 

Biomeme Protein Wash found in the second chamber of the M1 Sample Prep cartridge removes unwanted proteins that bound to the silica membrane in the Barbed Column Tip 

BWB 

Biomeme Wash Buffer found in the third chamber of the M1 Sample Prep cartridge removes other contaminants from the silica membrane in the Barbed Column Tip to ensure a highly pure sample 

Centrifuge 

A machine that generates centrifugal force, which at low speeds, can pull any droplets on the inside of the tube to the bottom without separating the components of the solution 

Fixed-Volume Pipette (20uL) 

Reusable pipette used to transfer 20uL of purified RNA template into lyophilized test strip (SARS-CoV-2 Go-Strip). To be used with corresponding pipette tips 

Flocked Specimen Collection Swabs 

Used to collect nasopharyngeal or nasal swab specimens. 

Franklin one9 Thermocycler 

Hand-held, battery-operated thermocycler. The Franklin one9 has 1 active color channel (FAM (green)) and 9 reaction wells (9 samples per run) 

Franklin three9 Thermocycler 

Hand-held, battery-operated thermocycler. The Franklin three9 has 3 active color channels (FAM (green), TexasRedX (amber), and ATTO647N (red)) and 9 reaction wells (9 samples per run) 

Franklin two9 Thermocycler 

Hand-held, battery-operated thermocycler. The Franklin two9 has 2 active color channels (FAM (green), ATTO647N (red)), and 9 reaction wells (9 samples per run) 

Go-Plate 

Pre-aliquoted 96-well PCR plate that contains our lyophilized master mix, enzymes, and multiplexed primer/probes 

Go-Strips 

Pre-aliquoted 3-well PCR strips that contain our lyophilized master mix, enzymes, and multiplexed primer/probes 

M1 Sample Prep Cartridge 

An easy-to-use method of nucleic acid extraction that generates a purified sample ready for PCR. Buffers come pre-aliquoted in the provided sample prep cartridges for ease of use, and the extraction method is designed to be completed in 6 simple steps 

M1 Sample Prep Cartridge Kit for RNA 2.0 

Used to extract purified RNA from samples. Sold in kits that include 96 cartridges, 96 syringes, and 96 columns (sufficient for preparing 96 samples) 

Molecular Grade Water (or Nuclease-Free Water) 

Water that is suitable for use in molecular biology applications which demands assurance that the water is free from DNases/RNases (nucleases) and protease contamination. This is often used as the sample for the NTC 

Preservation Buffer (for DNA or RNA) 

Biomeme's VTM that inactivates the virus and stabilizes the sample for long-term preservation 

Preservation Buffer Tubes (for DNA or RNA) 

Used to collect and maintain samples during transport and before molecular analysis 

Sample Prep Tray 

A product designed by Biomeme to organize and streamline sample preparation and extraction 

Void Filling Caps 

Rubber caps that are placed on top of Go-Strips to prevent evaporation of the sample during the PCR reaction 

Vortexer 

A machine commonly used in laboratories to adequately mix a solution with components that may have settled to the bottom. It is recommended that the RPC buffer be vortexed before use 

 

 

Other Words/Terms 

 

TERM 

DEFINITION 

Aliquot 

To separate a stock of solution into smaller volumes ideal for storage or to prevent stock contamination 

Amplicon 

The identical copies of the target nucleic acid produced through the PCR reaction 

Amplification 

The process by which the target nucleic acid is enzymatically replicated to produce identical copies. The most widely used amplification method is Polymerase Chain Reaction (PCR) 

Amplification Plot 

The graph that Real-Time qPCR results are displayed on. This can be accessed from the Biomeme Cloud and Biomeme Go app 

Assay 

In qPCR, this refers to all the target-specific components of the test, such as primers and probes 

Baseline View on the Biomeme Cloud 

This graph represents the data after it has been processed through an algorithm 

Biomeme Cloud 

A data management software that allows analysis of the results, and metrics for the Cq and RFU values, including standard deviation and mean