Where the diagnosis of Alport syndrome is suspected, a full clinical and family evaluation, together with molecular or pathological examination, (depending on local availability), are typically used to establish a diagnosis.[22]Savige J, Gregory M, Gross O, et al. Expert guidelines for the management of Alport syndrome and thin basement membrane nephropathy. J Am Soc Nephrol. 2013 Feb;24(3):364-75.
http://www.ncbi.nlm.nih.gov/pubmed/23349312?tool=bestpractice.com
Direct gene testing is recommended if patients have two or more diagnostic criteria for Alport syndrome.[21]Savige J, Ariani F, Mari F, et al. Expert consensus guidelines for the genetic diagnosis of Alport syndrome. Pediatr Nephrol. 2019 Jul;34(7):1175-89.
https://orbi.uliege.be/handle/2268/235913
http://www.ncbi.nlm.nih.gov/pubmed/29987460?tool=bestpractice.com
[23]Hanson H, Storey H, Pagan J, et al. The value of clinical criteria in identifying patients with X-linked Alport syndrome. Clin J Am Soc Nephrol. 2011 Jan;6(1):198-203.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3022243
http://www.ncbi.nlm.nih.gov/pubmed/20884774?tool=bestpractice.com
[24]Flinter FA, Cameron JS, Chantler C, et al. Genetics of classic Alport's syndrome. Lancet. 1988 Oct 29;2(8618):1005-7.
http://www.ncbi.nlm.nih.gov/pubmed/2902439?tool=bestpractice.com
Targeted molecular examination (e.g., detection of a COL4A5/6 contiguous gene deletion) may be used where symptoms and signs suggest a diagnosis of Alport syndrome with diffuse leiomyomatosis.
Clinical evaluation
Diagnosis should be considered in any child or adult (male or female) who presents with features compatible with a diagnosis of Alport syndrome. These include haematuria, proteinuria, deafness, hypertension, and renal failure. Symptoms may be vague and only relate to the development of renal failure such as fatigue, breathlessness, peripheral oedema, growth restriction, hypertension, and signs and symptoms of acidosis. If renal disease is associated with deafness then there is a high suspicion of the diagnosis, especially in males. A family history of these features should always be sought and screening for haematuria offered to first-degree relatives, especially parents, as this may identify familial disease. Patients should be screened for high-frequency sensorineural hearing loss and lenticonus (bulging of the lens capsule and the underlying cortex)/retinopathy even in the absence of symptoms.[2]Jacobs K, Meire FM. Lenticonus. Bull Soc Belge Ophtalmol. 2000;(277):65-70.
http://www.ncbi.nlm.nih.gov/pubmed/11126676?tool=bestpractice.com
[3]Kashtan C. Multidisciplinary management of Alport syndrome: current perspectives. J Multidiscip Healthc. 2021 May 21:14:1169-80.
https://www.dovepress.com/multidisciplinary-management-of-alport-syndrome-current-perspectives-peer-reviewed-fulltext-article-JMDH
http://www.ncbi.nlm.nih.gov/pubmed/34045864?tool=bestpractice.com
The presence of the characteristic central retinopathy, present in 40% to 70% of males, is said to be pathognomonic of the disease.[4]Jais JP, Knebelmann B, Giatras I, et al. X-linked Alport syndrome: natural history in 195 families and genotype-phenotype correlations in males. J Am Soc Nephrol. 2000 Apr;11(4):649-57.
https://journals.lww.com/jasn/fulltext/2000/04000/x_linked_alport_syndrome__natural_history_in_195.7.aspx
http://www.ncbi.nlm.nih.gov/pubmed/10752524?tool=bestpractice.com
[25]Perrin D, Jungers P, Grunfeld JP, et al. Perimacular changes in Alport's syndrome. Clin Nephrol. 1980 Apr;13(4):163-7.
http://www.ncbi.nlm.nih.gov/pubmed/7379367?tool=bestpractice.com
The following historical and symptomatic criteria suggest strong clinical evidence for the diagnosis of classic Alport syndrome.[24]Flinter FA, Cameron JS, Chantler C, et al. Genetics of classic Alport's syndrome. Lancet. 1988 Oct 29;2(8618):1005-7.
http://www.ncbi.nlm.nih.gov/pubmed/2902439?tool=bestpractice.com
[26]Savige J, Storey H, Watson E, et al. Consensus statement on standards and guidelines for the molecular diagnostics of Alport syndrome: refining the ACMG criteria. Eur J Hum Genet. 2021 Aug;29(8):1186-97.
https://www.nature.com/articles/s41431-021-00858-1
http://www.ncbi.nlm.nih.gov/pubmed/33854215?tool=bestpractice.com
Haematuria with or without progression to chronic kidney disease, together with a family history of haematuria or renal failure
Proteinuria
Progressive sensorineural hearing loss
Characteristic ocular changes (anterior lenticonus [bulging of the lens capsule and the underlying cortex]/maculopathy).[2]Jacobs K, Meire FM. Lenticonus. Bull Soc Belge Ophtalmol. 2000;(277):65-70.
http://www.ncbi.nlm.nih.gov/pubmed/11126676?tool=bestpractice.com
[3]Kashtan C. Multidisciplinary management of Alport syndrome: current perspectives. J Multidiscip Healthc. 2021 May 21:14:1169-80.
https://www.dovepress.com/multidisciplinary-management-of-alport-syndrome-current-perspectives-peer-reviewed-fulltext-article-JMDH
http://www.ncbi.nlm.nih.gov/pubmed/34045864?tool=bestpractice.com
Cataracts may be a presenting symptom.[15]Van Loo A, Vanholder R, Buytaert I, et al. Alport syndrome and diffuse leiomyomatosis with major morbid events presenting at adult age. Nephrol Dial Transplant. 1997 Apr;12(4):776-80.
https://academic.oup.com/ndt/article/12/4/776/1813896?login=false
http://www.ncbi.nlm.nih.gov/pubmed/9141011?tool=bestpractice.com
Typical ultra-structural changes in the glomerular basement membrane
Large family-based studies of X-linked Alport syndrome, the most common form, show that in male patients the most common clinical presentation (about 80%) is microscopic or macroscopic (gross) haematuria with or without proteinuria.[4]Jais JP, Knebelmann B, Giatras I, et al. X-linked Alport syndrome: natural history in 195 families and genotype-phenotype correlations in males. J Am Soc Nephrol. 2000 Apr;11(4):649-57.
https://journals.lww.com/jasn/fulltext/2000/04000/x_linked_alport_syndrome__natural_history_in_195.7.aspx
http://www.ncbi.nlm.nih.gov/pubmed/10752524?tool=bestpractice.com
Other presentations include proteinuria, deafness, chronic kidney disease, and hypertension.
Gross haematuria occurs in about 60% of patients.
Proteinuria is eventually found in most patients (>95%).
Hearing loss is present in about 80% of patients and eye signs in about 35%.
Aortic abnormalities have also been rarely described in affected males and may be found with echocardiogram.[27]Kashtan CE, Segal Y, Flinter F, et al. Aortic abnormalities in males with Alport syndrome. Nephrol Dial Transplant. 2010 Nov;25(11):3554-60.
http://www.ncbi.nlm.nih.gov/pubmed/20494893?tool=bestpractice.com
In women with X-linked Alport syndrome, more than 95% will have microscopic haematuria and 75% will develop proteinuria.[7]Jais JP, Knebelmann B, Giatras I, et al. X-linked Alport syndrome: natural history and genotype-phenotype correlations in girls and women belonging to 195 families: a "European Community Alport syndrome Concerted Action" study. J Am Soc Nephrol. 2003 Oct;14(10):2603-10.
https://journals.lww.com/jasn/fulltext/2003/10000/x_linked_alport_syndrome__natural_history_and.21.aspx
http://www.ncbi.nlm.nih.gov/pubmed/14514738?tool=bestpractice.com
Approximately 30% will have some hearing impairment and 15% will have eye signs.
Chronic kidney disease will develop in 12% before aged 40 years, which is correlated with the presence of proteinuria and deafness. Between 15% and 30% of women may develop renal failure by the aged 60 years, but further studies are required to verify this due to likely ascertainment bias in early studies.[28]Savige J, Colville D, Rheault M, et al. Alport syndrome in women and girls. Clin J Am Soc Nephrol. 2016 Sep 7;11(9):1713-20.
https://journals.lww.com/cjasn/fulltext/2016/09000/alport_syndrome_in_women_and_girls.25.aspx
http://www.ncbi.nlm.nih.gov/pubmed/27287265?tool=bestpractice.com
Steroid-resistant nephrotic syndrome, focal and segmental glomerulosclerosis, familial IgA glomerulonephritis, and end-stage kidney failure of unknown cause have also been associated with variants in COL4A3, COL4A4, and COL4A5 and are therefore considered an extension of the classical Alport phenotype.[26]Savige J, Storey H, Watson E, et al. Consensus statement on standards and guidelines for the molecular diagnostics of Alport syndrome: refining the ACMG criteria. Eur J Hum Genet. 2021 Aug;29(8):1186-97.
https://www.nature.com/articles/s41431-021-00858-1
http://www.ncbi.nlm.nih.gov/pubmed/33854215?tool=bestpractice.com
Further rare signs and symptoms associated with Alport syndrome are learning disability, dysphagia (caused by oesophageal leiomyomas), altered bowel habit (diffuse leiomyomatosis of the bowel wall) and cough or recurrent bronchitis (caused by bronchial leiomyomas).[13]Zhou J, Mochizuki T, Smeets H, et al. Deletion of the paired alpha 5(IV) and alpha 6(IV) collagen genes in inherited smooth muscle tumors. Science. 1993 Aug 27;261(5125):1167-1169.
http://www.ncbi.nlm.nih.gov/pubmed/8356449?tool=bestpractice.com
[14]Guillem P, Delcambre F, Cohen-Solal L, et al. Diffuse esophageal leiomyomatosis with perirectal involvement mimicking Hirschsprung disease. Gastroenterology. 2001 Jan;120(1):216-20.
https://www.doi.org/10.1053/gast.2001.20883
http://www.ncbi.nlm.nih.gov/pubmed/11208731?tool=bestpractice.com
Audiometry and ophthalmoscopy are recommended in all patients with suspected Alport syndrome to support diagnosis and guide management of the specific complications such as hearing loss and visual acuity.
See Assessment of hearing loss.
Molecular genetic testing
If, after a full clinical and family evaluation, there is a strong clinical suspicion of Alport syndrome, molecular diagnosis can be initially offered by targeted next generation sequencing, which can also confirm the mode of inheritance (see Aetiology).[16]Savige J, Lipska-Zietkiewicz BS, Watson E, et al. Guidelines for genetic testing and management of Alport syndrome. Clin J Am Soc Nephrol. 2022 Jan;17(1):143-54.
https://journals.lww.com/cjasn/fulltext/2022/01000/guidelines_for_genetic_testing_and_management_of.24.aspx
http://www.ncbi.nlm.nih.gov/pubmed/34930753?tool=bestpractice.com
[21]Savige J, Ariani F, Mari F, et al. Expert consensus guidelines for the genetic diagnosis of Alport syndrome. Pediatr Nephrol. 2019 Jul;34(7):1175-89.
https://orbi.uliege.be/handle/2268/235913
http://www.ncbi.nlm.nih.gov/pubmed/29987460?tool=bestpractice.com
[22]Savige J, Gregory M, Gross O, et al. Expert guidelines for the management of Alport syndrome and thin basement membrane nephropathy. J Am Soc Nephrol. 2013 Feb;24(3):364-75.
http://www.ncbi.nlm.nih.gov/pubmed/23349312?tool=bestpractice.com
[29]Kashtan CE, Gross O. Clinical practice recommendations for the diagnosis and management of Alport syndrome in children, adolescents, and young adults - an update for 2020. Pediatr Nephrol. 2021 Mar;36(3):711-9.
http://www.ncbi.nlm.nih.gov/pubmed/33159213?tool=bestpractice.com
It can be used to predict phenotype, and to help in offering prenatal and pre-implantation genetic diagnosis. Genetic counselling should be sought before testing. In Europe, genetic testing to confirm diagnosis is indicated over renal biopsy; however, in countries with a higher cost or lower availability, renal biopsy may be preferred.[26]Savige J, Storey H, Watson E, et al. Consensus statement on standards and guidelines for the molecular diagnostics of Alport syndrome: refining the ACMG criteria. Eur J Hum Genet. 2021 Aug;29(8):1186-97.
https://www.nature.com/articles/s41431-021-00858-1
http://www.ncbi.nlm.nih.gov/pubmed/33854215?tool=bestpractice.com
[29]Kashtan CE, Gross O. Clinical practice recommendations for the diagnosis and management of Alport syndrome in children, adolescents, and young adults - an update for 2020. Pediatr Nephrol. 2021 Mar;36(3):711-9.
http://www.ncbi.nlm.nih.gov/pubmed/33159213?tool=bestpractice.com
The current mutation detection rate in COL4A5 is high when direct sequencing and deletion screening strategies are used in patients who fulfil two or more diagnostic criteria (see Diagnostic criteria).[23]Hanson H, Storey H, Pagan J, et al. The value of clinical criteria in identifying patients with X-linked Alport syndrome. Clin J Am Soc Nephrol. 2011 Jan;6(1):198-203.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3022243
http://www.ncbi.nlm.nih.gov/pubmed/20884774?tool=bestpractice.com
[30]Martin P, Heiskari N, Zhou J, et al. High mutation detection rate in the COL4A5 collagen gene in suspected Alport syndrome using PCR and direct DNA sequencing. J Am Soc Nephrol. 1998 Dec;9(12):2291-301.
http://jasn.asnjournals.org/content/9/12/2291.full.pdf+html
http://www.ncbi.nlm.nih.gov/pubmed/9848783?tool=bestpractice.com
[31]Hertz JM, Thomassen M, Storey H, et al. Clinical utility gene card for: Alport syndrome. Eur J Hum Genet. 2012 Jun;20(6):ejhg.2011.237.
http://www.ncbi.nlm.nih.gov/pubmed/22166944?tool=bestpractice.com
Many genetic testing laboratories deposit COL4A3, COL4A4, and COL4A5 variants in a fully curated and standardised database, with the aim of improving the accuracy of genetic testing and prediction of phenotype.[32]Savige J, Ars E, Cotton RG, et al; The International Alport Mutation Consortium. DNA variant databases improve test accuracy and phenotype prediction in Alport syndrome. Pediatr Nephrol. 2014 Jun;29(6):971-77.
http://www.ncbi.nlm.nih.gov/pubmed/23720012?tool=bestpractice.com
cDNA may also be tested and can be obtained from hair root and skin biopsy samples.[33]Tazon-Vega B, Ars E, Burset M, et al. Genetic testing for X-linked Alport syndrome by direct sequencing of COL4A5 cDNA from hair root RNA samples. Am J Kidney Dis. 2007 Aug;50(2):257.e1-e14.
http://www.ncbi.nlm.nih.gov/pubmed/17660027?tool=bestpractice.com
Testing can confirm linkage to COL4A5 in X-linked Alport syndrome or COL4A3/4 in autosomal Alport syndrome.
Genetic testing can also aid in establishing a diagnosis when patients present with non-classical findings, as presentation can vary greatly depending on age of presentation, sex, and mode of inheritance.[26]Savige J, Storey H, Watson E, et al. Consensus statement on standards and guidelines for the molecular diagnostics of Alport syndrome: refining the ACMG criteria. Eur J Hum Genet. 2021 Aug;29(8):1186-97.
https://www.nature.com/articles/s41431-021-00858-1
http://www.ncbi.nlm.nih.gov/pubmed/33854215?tool=bestpractice.com
Diagnosis is established by the identification of a pathogenic or likely pathogenic variant in COL4A3, COL4A4, or COL4A5.[16]Savige J, Lipska-Zietkiewicz BS, Watson E, et al. Guidelines for genetic testing and management of Alport syndrome. Clin J Am Soc Nephrol. 2022 Jan;17(1):143-54.
https://journals.lww.com/cjasn/fulltext/2022/01000/guidelines_for_genetic_testing_and_management_of.24.aspx
http://www.ncbi.nlm.nih.gov/pubmed/34930753?tool=bestpractice.com
[26]Savige J, Storey H, Watson E, et al. Consensus statement on standards and guidelines for the molecular diagnostics of Alport syndrome: refining the ACMG criteria. Eur J Hum Genet. 2021 Aug;29(8):1186-97.
https://www.nature.com/articles/s41431-021-00858-1
http://www.ncbi.nlm.nih.gov/pubmed/33854215?tool=bestpractice.com
Finding a relevant COL4A3-COL4A5 variant also indicates that other family members should be investigated.[26]Savige J, Storey H, Watson E, et al. Consensus statement on standards and guidelines for the molecular diagnostics of Alport syndrome: refining the ACMG criteria. Eur J Hum Genet. 2021 Aug;29(8):1186-97.
https://www.nature.com/articles/s41431-021-00858-1
http://www.ncbi.nlm.nih.gov/pubmed/33854215?tool=bestpractice.com
Renal investigations and complication monitoring
Renal biopsy with electron microscopy and immunohistochemical analysis for type IV collagens allows for diagnosis of Alport syndrome to be confirmed in most cases. Occasionally renal biopsy is contraindicated, which would prevent a pathological diagnosis being made. It is the characteristic electron microscopic changes of thinning, thickening, splitting, and lamellation of the glomerular basement membrane that should be sought in renal biopsies where Alport syndrome is a possible diagnosis. Renal ultrasound also excludes any structural abnormality of the renal tract that may suggest an alternative diagnosis.
Routine investigations for renal disease are also done. They can also be used to monitor decline in renal function:
FBC
Urinalysis
Fasting lipid panel
Metabolic panel
Serum intact PTH
ECG
Echocardiogram
Skin biopsy
Skin biopsy is less invasive than renal biopsy, and where immunohistochemistry for type IV collagens is available it can be considered as part of the diagnostic approach although is rarely used. It is also faster than molecular testing. Total absence of alpha-5(IV) staining in the epidermal basement membrane is seen in males, and focal absence (or mosaic distribution) in females is seen in 50% to 60% of families.[34]Gubler MC. Diagnosis of Alport syndrome without biopsy? Pediatr Nephrol. 2007 May;22(5):621-5.
http://www.ncbi.nlm.nih.gov/pubmed/17143627?tool=bestpractice.com
Skin biopsy is of little value in autosomal forms of Alport syndrome.