Understanding diagnostic laboratory tests for invisible illnesses. This guide covers what each test measures, its limitations, approximate costs, and questions to ask your doctor. Always discuss results with a qualified healthcare provider.
Tick-borne Borrelia burgdorferi infection
First-tier screening test that detects antibodies (IgM and IgG) against Borrelia burgdorferi. Used as the initial screening step in the CDC-recommended two-tier testing algorithm.
Key Notes
With Insurance
$20-50 copay
Without Insurance
$75-200
Turnaround
1-3 days
Second-tier confirmatory test that identifies specific antibody bands against Borrelia proteins. IgM is relevant for early infection (first 4 weeks); IgG for infections lasting longer than 4-6 weeks.
Key Notes
With Insurance
$30-60 copay
Without Insurance
$150-350
Turnaround
3-7 days
A newer single-tier test using the C6 peptide (VlsE invariable region 6) that can detect both IgM and IgG responses. FDA-approved as an alternative to the standard two-tier approach.
Key Notes
With Insurance
$25-55 copay
Without Insurance
$100-250
Turnaround
2-5 days
Common laboratory markers encountered across invisible illness evaluations. Normal ranges may vary by laboratory. Always interpret results in clinical context with your healthcare provider.
Marker
CRP (C-Reactive Protein)
Normal Range
< 3.0 mg/L (standard); < 1.0 mg/L (hs-CRP low risk)
If Abnormal
Elevated levels indicate systemic inflammation. Common in acute infections, autoimmune flares, and chronic inflammatory conditions. Non-specific.
When to Retest
4-6 weeks if elevated; monitor trend rather than single values
Marker
ESR (Erythrocyte Sedimentation Rate)
Normal Range
0-20 mm/hr (women); 0-15 mm/hr (men)
If Abnormal
Elevated ESR suggests inflammation but is slower to respond than CRP. Can be elevated in infections, autoimmune disease, and malignancy.
When to Retest
4-8 weeks if elevated
Marker
ANA (Antinuclear Antibody)
Normal Range
Negative (titer < 1:40)
If Abnormal
Positive ANA occurs in lupus, Sjogren's, scleroderma, and other autoimmune conditions. Also positive in ~15% of healthy individuals at low titers.
When to Retest
Confirm once; pattern and titer guide further workup (anti-dsDNA, anti-Smith, anti-SSA/SSB)
Marker
TSH (Thyroid Stimulating Hormone)
Normal Range
0.4-4.0 mIU/L
If Abnormal
High TSH = hypothyroidism (fatigue, weight gain, brain fog). Low TSH = hyperthyroidism. Both can mimic chronic illness symptoms.
When to Retest
6-8 weeks after treatment initiation or dose change
Marker
Ferritin
Normal Range
20-200 ng/mL (women); 20-500 ng/mL (men)
If Abnormal
Low ferritin = iron deficiency (fatigue, exercise intolerance). Elevated ferritin = inflammation, iron overload, or chronic disease.
When to Retest
8-12 weeks after iron supplementation; 3-6 months for monitoring
Marker
Vitamin D (25-OH)
Normal Range
30-100 ng/mL (optimal: 40-60 ng/mL)
If Abnormal
Deficiency (< 20 ng/mL) or insufficiency (20-29 ng/mL) is common in chronic illness and associated with fatigue, pain, and immune dysfunction.
When to Retest
3 months after supplementation initiation
Marker
D-dimer
Normal Range
< 500 ng/mL (age-adjusted: age x 10 for patients > 50)
If Abnormal
Elevated levels indicate fibrin degradation (clot breakdown). Seen in DVT/PE, DIC, infection, inflammation, Long COVID microclotting.
When to Retest
As clinically indicated; not a routine monitoring test
Every 510(k)-cleared diagnostic device matching “Lyme” or “Borrelia” in the FDA database (105 devices, pulled August 26, 2026). 510(k) clearance means substantially equivalent to a legally marketed predicate — it is not FDA approval. A test absent from this list has no matching 510(k) record; that alone does not make it invalid.
| Test | Manufacturer | Cleared | 510(k) |
|---|---|---|---|
| Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | Jul 10, 2026 | K254295 |
| Lyme-ID IgG Test; Bio-ID800 | Inanovate, Inc. | Nov 14, 2025 | K252627 |
| iDart Lyme IgM ImmunoBlot Kit | Id-Fish Technology, Inc. | Jun 12, 2025 | K242872 |
| iDart Lyme IgG ImmunoBlot Kit | Id-Fish Technology, Inc. | Aug 12, 2024 | K233367 |
| ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit | Zeus Scientific | Jul 13, 2023 | K230863 |
| Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | Mar 22, 2021 | K203289 |
| Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | Mar 22, 2021 | K203292 |
| Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics | Mar 22, 2021 | K203295 |
| Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics | Mar 22, 2021 | K203296 |
| LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus | DiaSorin, Inc. | Feb 18, 2021 | K202573 |
| LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus | DiaSorin, Inc. | Feb 18, 2021 | K202574 |
| Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics | Apr 6, 2020 | K200023 |
| Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics | Apr 6, 2020 | K200025 |
| LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set | DiaSorin, Inc. | Jan 29, 2020 | K193051 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System | Zeus Scientific, Inc. | Jul 29, 2019 | K190907 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System | Zeus Scientific, Inc. | Jul 29, 2019 | K191240 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System | Zeus Scientific, Inc. | Jul 29, 2019 | K191398 |
| BioPlex 2200 Lyme Total | Bio-Rad Laboratories | Mar 12, 2019 | K183446 |
| Sofia 2 Lyme FIA, Sofia Lyme Control Set | Quidel Corporation | Aug 30, 2018 | K173496 |
| Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | May 2, 2018 | K180264 |
| Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack | Quidel Corporation | Feb 28, 2018 | K173691 |
| Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | Euroimmun Us, Inc. | Dec 10, 2017 | K172722 |
| Lyme B. burgdorferi (IgM) MarStripe Test | Trinity Biotech | Oct 23, 2017 | K172254 |
| Sofia Lyme FIA, Sofia Lyme Control Set | Quidel Corporation | Oct 20, 2017 | K163713 |
| Borrelia B31 ViraChip IgM Test Kit | Viramed Biotech AG | Aug 22, 2017 | K163695 |
| Borrelia B31 ViraChip IgG Test Kit | Viramed Biotech AG | Jul 12, 2017 | K163504 |
| Lyme B. burgdorferi (IgG) MarStripe Test | Trinity Biotech | Feb 1, 2017 | K163095 |
| Anti-Borrelia burgdorferi US Westernblot (IgG) | Euroimmun US | Aug 25, 2016 | K161513 |
| VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II | BIOMERIEUX | Jul 9, 2015 | K141133 |
| EUROIMMUN LYME ELISA(IgG/IgM) | Euroimmun US | May 4, 2015 | K142038 |
| VIDAS LYME IGM | Biomerieux S.A. | Jun 4, 2013 | K122979 |
| VIDAS LYME IGG | Biomerieux S.A. | Mar 5, 2013 | K122986 |
| ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM | Zeus Scientific, Inc. | Jul 26, 2012 | K113397 |
| BORRELIA BURGDORFERI IGM BLOT TEST | Gold Standard Diagnostics | Jun 1, 2012 | K113846 |
| BORRELIA BURGDORFERI IGG BLOT TEST | Gold Standard Diagnostics | Apr 11, 2012 | K113847 |
| ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM | Zeus Scientific, Inc. | Jul 6, 2010 | K100728 |
| VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS | Viramed Biotech AG | Nov 25, 2009 | K092693 |
| VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE | Viramed Biotech AG | Aug 5, 2009 | K082329 |
| PLATELIA LYME IGM | Bio-Rad | Jun 26, 2008 | K081362 |
| PLATELIA LYME IGG ASSAY | Bio-Rad | May 8, 2008 | K080012 |
| LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871 | DiaSorin, Inc. | Apr 12, 2007 | K062473 |
| VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT | Viramed Biotech AG | Aug 11, 2005 | K051071 |
| BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT | Viramed Biotech AG | Aug 11, 2005 | K051169 |
| BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM | Trinity Biotech USA | Nov 26, 2003 | K033070 |
| BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | Trinity Biotech USA | Nov 26, 2003 | K033083 |
| BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG | Boston Biomedica, Inc. | Nov 24, 2003 | K032713 |
| IMMUNETICS C6 LYME ELISA KIT | Immunetics, Inc. | May 10, 2001 | K003754 |
| QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT | Inova Diagnostics, Inc. | Jan 27, 2000 | K994004 |
| BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM | Zeus Scientific, Inc. | Sep 3, 1999 | K991180 |
| BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM | Zeus Scientific, Inc. | Sep 3, 1999 | K991185 |
| QUANTA LITE LYME IGG ELISA | Inova Diagnostics, Inc. | Apr 15, 1999 | K984222 |
| QUANTA LITE LYME IGM ELISA | Inova Diagnostics, Inc. | Apr 15, 1999 | K984234 |
| PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY | Chembio Diagnostic Systems, Inc. | Feb 12, 1999 | K981913 |
| IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | Columbia Bioscience, Inc. | Dec 16, 1998 | K983605 |
| IS BORRELIA BURGDORFERI IGM TEST SYSTEM | Columbia Bioscience, Inc. | Dec 16, 1998 | K983606 |
| LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G) | Mrl Diagnostics | Jun 1, 1998 | K971006 |
| LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) | Mrl Diagnostics | Jun 1, 1998 | K971007 |
| LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) | Cambridge Diagnostics Ireland, Ltd. | Apr 9, 1998 | K970761 |
| HUMAN LYME IGM WESTERN BLOT KIT | Cambridge Diagnostics Ireland, Ltd. | Apr 9, 1998 | K970768 |
| CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111) | Cambridge Biotech Corp. | Feb 17, 1998 | K971169 |
| CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112) | Cambridge Biotech Corp. | Feb 17, 1998 | K971170 |
| ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL | Boston Biomedica, Inc. | Feb 5, 1998 | K974809 |
| ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL | Boston Biomedica, Inc. | Feb 5, 1998 | K974810 |
| BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM | Wampole Laboratories | Mar 26, 1997 | K965129 |
| BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | Wampole Laboratories | Mar 26, 1997 | K965131 |
| MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM | Mardx Diagnostics, Inc. | Jun 7, 1996 | K951709 |
| MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM | Mardx Diagnostics, Inc. | Jun 5, 1996 | K950829 |
| IMMUNO DOT BORRELIA DOT BLOT G TEST | Genbio | May 3, 1996 | K953682 |
| MMUNO DOT BORRELIA DOT BLOT M TEST | Genbio | May 3, 1996 | K953683 |
| VIDAS LYME SCREEN II | Biomerieux Vitek, Inc. | Jun 13, 1995 | K943812 |
| BARTELS LYME DISEASE IGM EIA | Baxter Diagnostics, Inc. | Sep 2, 1992 | K922578 |
| IMMUNODOT BORRELIA (LYME) TEST | General Biometrics, Inc. | Apr 8, 1992 | K911627 |
| IMMUNOWELL LYME (P39 RECOMBINANT) TEST | General Biometrics, Inc. | Dec 30, 1991 | K911599 |
| IMMUNOWELL BORRELIA (LYME)TEST | General Biometrics, Inc. | Dec 20, 1991 | K911590 |
| LYME-CHECK(TM) TEST KIT | Diagnostic Technology, Inc. | Nov 5, 1991 | K896378 |
| LYME STAT M TEST KIT | Whittaker Bioproducts, Inc. | Oct 21, 1991 | K904652 |
| FIAX LYME M TEST KIT | Whittaker Bioproducts, Inc. | Oct 16, 1991 | K904893 |
| LYME-SPOT IF KIT | Vitek Systems, Inc. | Aug 30, 1991 | K910230 |
| LYME DISEASE IGM ELISA | Hillcrest Biologicals | Jun 28, 1991 | K900206 |
| LYME IGM ELISA TEST | Gull Laboratories, Inc. | Jun 21, 1991 | K903013 |
| LYME DISEASE MICROASSAY | Diamedix Corp. | Jun 10, 1991 | K910899 |
| LYME IGM MICROASSAY | Diamedix Corp. | Jun 10, 1991 | K911330 |
| BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST | Medical Diagnostic Technologies, Inc. | May 10, 1991 | K911145 |
| LYME IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | May 2, 1990 | K900196 |
| LYME IGM MICROASSAY | Diamedix Corp. | May 2, 1990 | K900572 |
| BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE | Bion Ent., Ltd. | Apr 5, 1990 | K901054 |
| LYME IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | Dec 13, 1989 | K895292 |
| IMMUNODOT LYME TEST | General Biometrics, Inc. | Oct 30, 1989 | K894410 |
| MARDX LYME DISEASE IFA (IGM) TEST SYSTEM | Mardx, Inc. | Sep 19, 1989 | K894609 |
| MARDX LYME DISEASE EIA (IGG) TEST SYSTEM | Mardx Diagnostics, Inc. | Aug 21, 1989 | K894224 |
| MARDX LYME DISEASE EIA (IGM) TEST SYSTEM | Mardx Diagnostics, Inc. | Aug 21, 1989 | K894293 |
| LYME DISEASE MICROASSAY | Diamedix Corp. | Jul 25, 1989 | K890843 |
| MARDX LYME DISEASE IGG IFA TEST SYSTEM | Mardx Diagnostics, Inc. | Apr 18, 1989 | K890053 |
| BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY | Medical Diagnostic Technologies, Inc. | Apr 10, 1989 | K885290 |
| BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM | Medical Diagnostic Technologies, Inc. | Apr 10, 1989 | K885293 |
| BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM | Medical Diagnostic Technologies, Inc. | Apr 10, 1989 | K885294 |
| LYME DISEASE IFA (IGM) | Hillcrest Biologicals | Mar 15, 1989 | K883767 |
| HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES | Cambridge Bioscience Corp. | Mar 15, 1989 | K890281 |
| LYME ELISA TEST SYSTEM | Zeus Scientific, Inc. | Mar 2, 1989 | K885317 |
| LYME FAST TEST | 3M Company | Jan 13, 1989 | K883544 |
| LYME DISEASE IFA (IGG) | Hillcrest Biologicals | Dec 13, 1988 | K883487 |
| LYME DISEASE ELISA | Hillcrest Biologicals | Apr 26, 1988 | K880476 |
| LYME STAT TEST KIT | Whittaker Bioproducts, Inc. | Mar 30, 1988 | K875286 |
| FIAX TEST KIT FOR LYME DISEASE ANTIBODIES | Whittaker Bioproducts, Inc. | Oct 15, 1987 | K872247 |
| IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI | Zeus Scientific, Inc. | Aug 25, 1987 | K871246 |
Source: openFDA device 510(k) API. K-numbers link to the FDA record.